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Credit. IStock Share Fast Facts New @HopkinsMedicine study finds African-American women with common form of hair loss at increased risk of uterine fibroids - Click to Tweet New study in @JAMADerm shows most common form of alopecia (hair loss) in African-American women associated with higher risks of uterine fibroids - Click to Tweet In a study of medical records gathered on hundreds of thousands of African-American women, Johns Hopkins researchers say they have evidence that women with a common form of hair loss have an increased chance of developing uterine leiomyomas, or fibroids.In a report on the research, published in the December 27 issue of JAMA Dermatology, the researchers call on physicians who treat women with central centrifugal cicatricial alopecia (CCCA) to make patients aware that they may be at increased risk for fibroids and should be screened for the condition, particularly if they have symptoms such as heavy bleeding and pain. CCCA predominantly affects black women and is the most common form of permanent alopecia in this population. The excess scar tissue that forms as a result of this type of hair loss may also explain the higher risk for uterine fibroids, which are characterized by fibrous growths in the lining of the womb.

Crystal Aguh, M.D., assistant professor of dermatology at the Johns Hopkins University School of Medicine, says the scarring associated with CCCA is similar to the scarring associated with excess fibrous tissue elsewhere in the body, a situation that may explain why women with this type of hair loss are at a higher risk for fibroids.People of African descent, she notes, are more prone to develop other disorders of abnormal scarring, termed fibroproliferative disorders, such as keloids (a type of raised scar after trauma), scleroderma (an autoimmune disorder marked by thickening of the skin as well as internal organs), some types of lupus and clogged arteries. During a four-year period from 2013-2017, the researchers analyzed patient data from the Johns Hopkins electronic medical record system (Epic) of 487,104 black women ages 18 and over. The prevalence of those with fibroids was compared in patients with and without CCCA. Overall, the researchers found that 13.9 percent of women with CCCA also had a history of uterine fibroids compared to only 3.3 percent of black women without the condition.

In absolute numbers, out of the 486,000 women who were reviewed, 16,212 had fibroids.Within that population, 447 had CCCA, of which 62 had fibroids. The findings translate to a fivefold increased risk of uterine fibroids in women with CCCA, compared to age, sex and race matched controls. Aguh cautions that their study does not suggest any cause and effect relationship, or prove a common cause for both conditions. ÂThe cause of the link between the two conditions remains unclear,â she says.

However, the association was strong enough, she adds, to recommend that physicians and patients be made aware of it. Women with this type of scarring alopecia should be screened not only for fibroids, but also for other disorders associated with excess fibrous tissue, Aguh says. An estimated 70 percent of white women and between 80 and 90 percent of African-American women will develop fibroids by age 50, according to the NIH, and while CCCA is likely underdiagnosed, some estimates report a prevalence of rates as high as 17 percent of black women having this condition. The other authors on this paper were Ginette A.

Okoye, M.D. Of Johns Hopkins and Yemisi Dina of Meharry Medical College.Credit. The New England Journal of Medicine Share Fast Facts This study clears up how big an effect the mutational burden has on outcomes to immune checkpoint inhibitors across many different cancer types. - Click to Tweet The number of mutations in a tumorâs DNA is a good predictor of whether it will respond to a class of cancer immunotherapy drugs known as checkpoint inhibitors.

- Click to Tweet The âmutational burden,â or the number of mutations present in a tumorâs DNA, is a good predictor of whether that cancer type will respond to a class of cancer immunotherapy drugs known as checkpoint inhibitors, a new study led by Johns Hopkins Kimmel Cancer Center researchers shows. The finding, published in the Dec. 21 New England Journal of Medicine, could be used to guide future clinical trials for these drugs. Checkpoint inhibitors are a relatively new class of drug that helps the immune system recognize cancer by interfering with mechanisms cancer cells use to hide from immune cells.

As a result, the drugs cause the immune system to fight cancer in the same way that it would fight an . These medicines have had remarkable success in treating some types of cancers that historically have had poor prognoses, such as advanced melanoma and lung cancer. However, these therapies have had little effect on other deadly cancer types, such as pancreatic cancer and glioblastoma. The mutational burden of certain tumor types has previously been proposed as an explanation for why certain cancers respond better than others to immune checkpoint inhibitors says study leader Mark Yarchoan, M.D., chief medical oncology fellow.

Work by Dung Le, M.D., associate professor of oncology, and other researchers at the Johns Hopkins Kimmel Cancer Center and its Bloomberg~Kimmel Cancer Institute for Cancer Immunotherapy showed that colon cancers that carry a high number of mutations are more likely to respond to checkpoint inhibitors than those that have fewer mutations. However, exactly how big an effect the mutational burden has on outcomes to immune checkpoint inhibitors across many different cancer types was unclear. To investigate this question, Yarchoan and colleagues Alexander Hopkins, Ph.D., research fellow, and Elizabeth Jaffee, M.D., co-director of the Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care and associate director of the Bloomberg~Kimmel Institute, combed the medical literature for the results of clinical trials using checkpoint inhibitors on various different types of cancer. They combined these findings with data on the mutational burden of thousands of tumor samples from patients with different tumor types.

Analyzing 27 different cancer types for which both pieces of information were available, the researchers found a strong correlation. The higher a cancer typeâs mutational burden tends to be, the more likely it is to respond to checkpoint inhibitors. More than half of the differences in how well cancers responded to immune checkpoint inhibitors could be explained by the mutational burden of that cancer. ÂThe idea that a tumor type with more mutations might be easier to treat than one with fewer sounds a little counterintuitive.

Itâs one of those things that doesnât sound right when you hear it,â says Hopkins. ÂBut with immunotherapy, the more mutations you have, the more chances the immune system has to recognize the tumor.â Although this finding held true for the vast majority of cancer types they studied, there were some outliers in their analysis, says Yarchoan. For example, Merkel cell cancer, a rare and highly aggressive skin cancer, tends to have a moderate number of mutations yet responds extremely well to checkpoint inhibitors. However, he explains, this cancer type is often caused by a ventolin, which seems to encourage a strong immune response despite the cancerâs lower mutational burden.

In contrast, the most common type of colorectal cancer has moderate mutational burden, yet responds poorly to checkpoint inhibitors for reasons that are still unclear. Yarchoan notes that these findings could help guide clinical trials to test checkpoint inhibitors on cancer types for which these drugs havenât yet been tried. Future studies might also focus on finding ways to prompt cancers with low mutational burdens to behave like those with higher mutational burdens so that they will respond better to these therapies. He and his colleagues plan to extend this line of research by investigating whether mutational burden might be a good predictor of whether cancers in individual patients might respond well to this class of immunotherapy drugs.

ÂThe end goal is precision medicineâmoving beyond whatâs true for big groups of patients to see whether we can use this information to help any given patient,â he says. Yarchoan receives funding from the Norman &. Ruth Rales Foundation and the Conquer Cancer Foundation. Through a licensing agreement with Aduro Biotech, Jaffee has the potential to receive royalties in the future..

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These ourare favorite blogs ands do you give ventolin to croup support groups thatexplain the http://blog.hiddenblessings.com/2010/09/21/hello-world/ experience of life with hearing loss. Sites for people with hearing loss The Hearing Health Foundation The Hearing Health Foundationâs mission is to prevent and cure hearing loss and tinnitus through research. They are the largest private funder of hearing research and have awarded millions of dollars since their organization in 1958. They maintain a hearing health blog and write a free magazine, Hearing Health Magazine, do you give ventolin to croup which keeps donors informed of the latest hearing health discoveries and provides a directory of annual summer camps for children and adults with hearing loss.

Readers can learn about hearing loss, its prevention and current research on the site or get involved by sharing their hearing loss story and donating to the cause. Hearing Journey If youâve received a cochlear implant or have hearing loss, you may want to join this community sponsored by Advance Bionics and the Bionic Ear Association. Readers do you give ventolin to croup can learn about cochlear implants and hearing loss, post questions for other readers to respond to or share stories about their hearing loss journey. The home page lists the names of current conversations along with the top categories of discussions.

Readers must register to view the content. Oticon Medical Friends If you or do you give ventolin to croup a loved one wears a Ponto bone-anchored hearing aid, you may already know about this patient-focused site. Oticon Medical Friends lets users connect with other Ponto users across the world. You must register to use the site.

Oticon Medical also helps maintain the Bone Anchored Hearing Systems (BAHS) do you give ventolin to croup Blog, which features real patient stories and journeys. Hearing Like Me This online community is sponsored by Phonak, a hearing device manufacturer. The corporate presence isnât overwhelming at all, instead giving space to people with hearing loss who want to connect with others who are experiencing the same challenges. Readers can view most of the information without registering unless they do you give ventolin to croup are planning to participate in the online forums.

Deaf and Hard of Hearing The mission of this website, established in 2008, is to empower the hearing loss community by promoting confident social interaction and open communication. The site also maintains a directory of summer camps and daycares for deaf and hard of hearing children, profiles a member of the month, and keeps a directory of audiologists, hearing care facilities and schools for the deaf and hard of hearing. No registration do you give ventolin to croup is required. However, readers are encouraged to register and receive access to chat live with other members.

Bloggers and writers we love Smart Hearing Journalist and author Katherine Bouton has written several books about hearing loss, but in recent years she's also become an advocate and educator for people who are hearing-impaired. This approach shines through on her blog, which she uses to provide "strategies, skills, and resources for living better with hearing loss." This is perhaps because she herself has hearing lossâshe uses a do you give ventolin to croup cochlear implant for one ear, and a hearing aid for the other. We highly recommend Katherine's blog for staying up-to-date on the real-world experiences of people with hearing loss. My Hearing Loss Story Carly, who has single-sided deafness, candidly shares the ups and downs of suddenly losing her hearing at her blog, Hearing Loss Story.

She also delves into the practical, from tackling how to wear a mask with do you give ventolin to croup hearing loss during the asthma treatment ventolin, to her struggles with tinnitus. Her warm and empathic voice are like a warm cup of tea on a rainy day. "I started this blog as a way to inform my friends and family about my progress, for anyone else who is going through a similar experience as me, or for anybody who is interested in learning about this type of hearing loss, and the way it can affect everyday life," Carly explains. Note.

Carly also shared her experience with us using a CROS hearing aid. My Thoughts You have to love an authentic person and Jennifer Gibson definitely fits that bill. She writes about growing up with severe hearing loss with honesty, passion and clarity. Her post about traveling with hearing loss not only gives hearing individuals a glimpse into what that might be like, it also gives those with hearing loss a few great tips for navigating on their own.

Did we mention she is also a published author, graphic designer and illustrator?. Her trilogy, "Sway, Compass and Destiny," follows the adventures of Jessie, a teenager with hearing loss. The award-winning books can be purchased on her website. Hands and Voices This group blog, facilitated by Karen Putz, is still going strong, with touching posts from parents with deaf or hard of hearing children.

Recent topics include the parenting during the ventolin and parenting a child who has hearing loss and Down syndrome. Lipreading Mom Since we last touched base with Shanna Groves, she has decided to scale back her book writing and public speaking activities. Thankfully, her faithful readers can still hear her strong, passionate voice about being a mom with hearing loss in her blog posts. ÂLipreadingMom.com is not about being an author or speaker,â she writes.

ÂIt is a connection with other people who may live with hearing loss. It is a connection with other parents and grandparents. Through the sharing of our everyday experiences, we can inspire, inform and entertain. In other words, we can make the world of parenting with a hearing loss not such a lonely place.â Living with Hearing Loss Hearing loss advocate and writer Shari Eberts updates her blog frequently, focusing on functional advice for people dealing with hearing impairments.

The blog helps to "serve as an outlet for my experiences as well as a community for those dealing with similar issues," Shari says. Her site is thorough and excellent, we recommend starting with her "most popular posts" page to get a sense of what you'll find. Cochlear Implant Life "The decision to have a Cochlear Implant is one that has changed my life. But, the path to achieving success with it did not happen overnight," writes Aiden Toominator, who manages the site and a related newsletter and YouTube channel.

Cochlear Implant Life has helpful reviews of new products, stories from CI users and an online shop. Rewiring Tinnitus Rewiring Tinnitus blogger and life coach Glenn Schweitzer has made a career out of a bad situation. A diagnosis of Meniere's disease and resulting tinnitus. Based on what he learned overcoming a challenging health situation, he now shares his experience and tips on his site.

"If you suffer from tinnitus, I want you to know right now that there is so much hope. No matter how severe your tinnitus is, or how bad things may seem, you can learn to live with your tinnitus, too," Glenn shares on his site. (Note. Glenn is also a Healthy Hearing columnist.) Share your story Got a hearing loss blog or vlog that you'd like featured on this list?.

Please contact us.Cold wintry weather can cause hearing aid damage if proper precautions aren't taken. While often hearing aids can be repaired, an ounce of prevention is worth a pound of cure. Here's some information on how cold weather and moisture can damage hearing aids, what to be aware of and how you can prevent weather damage. Also, find out about tinnitus and winter weather, and why clogged ears are more common in cold weather.Hearing aids, cold weather and moisture Moisture and condensation can quicklydamage hearing aids.

Temperature extremes can be damaging to a hearing aid and its batteries. The cold itself is not necessarily damaging, but the condensation that occurs due to temperature change can damage internal components. Even when it isn't snowing or raining, moisture is present because extreme temperature changes are common in the winter. For example, if you are walking outside and the temperature is 20 degrees Fahrenheit, you will almost certainly be bundled up from head to toe with a hat over your ears.

But when you head indoors, it could be nearly 50 degrees warmer because the heat is on. Even if you take off your coat and other winter gear right away, the temperature change can form condensation on your hearing aids. And maybe you were walking quickly and your head began to sweat, which could also damage your hearing aids and batteries. Signs of moisture damage Moisture can ruin the microphone and receiver of your hearing aids, as well as clog the earmold tubing and sound and cause corrosion.

Here are some tell-tale signs that your hearing aids have been damaged. Your hearing aid cuts out during loud noises. The sound fades or comes and goes. Everything you hear is punctuated by static.

Sounds are unclear or seem distorted. Your hearing aid completely stops working and then starts again. This might happen a few times. Hearing aid fixes If you think your hearing aids have been exposed to moisture, there are other things to check first.

Such as. Your hearing aid is turned on and (if you have one) the T-switch is in the right position. If you have disposable batteries, make sure they have been inserted correctly. Also, sometimes when batteries are dying, you will see some of the same signs as above.

Check to make sure the battery is not corroded. If it is, it will have a white powdery substance and should be thrown out immediately. The battery contacts, which are the points where the batteries touch the hearing aids. Clean them or remove moisture with a dry cotton swab.

The earmold, to be sure it or the sound outlet are not clogged with wax. Or, if you wear domes (a tiny cone that's inserted deep in the ear), make sure they are not damaged. More. How to troubleshoot common hearing aid problems If none of these things seem to be the issue, you may have moisture in your hearing aid.

If you wear behind-the-ear (BTE) hearing aids, look in the tubing for moisture droplets. If you wear earmolds, you can purchase an earmold puffer, which blows out any moisture, and consider having your earmolds fitted with a moisture dispersing tube. For in-the-ear (ITE) hearing aids, it's a little trickier to remove the moisture. If you don't already have one, purchase a hearing aid drying device and place your hearing aids in it immediately to hopefully dry them out and avoid damage.

Not sure what kind of hearing aid you have?. Check out our primer on hearing aid types and styles. Precautions for cold weather and hearing aids While moisture is hard to avoid in extreme cold, there are some precautions you can take in an attempt to keep your hearing aids dry and safe. Protect with earmuffs Earmuffs aren't only for keeping your ears warm while you're skating on the neighborhood pond or ice fishing with your favorite nephew.

Specialized earmuffs are available specifically for protecting your ears from damaging noise. Even if you already have hearing loss, further damage from noise is almost completely preventable by simply limiting your exposure. Noise-reduction earmuffs are not just for winter. In fact, they will come in handy many times throughout the year.

Whether you're using your noisy lawnmower in the spring, enjoying a fireworks show in the summer and taking in a football game in a noisy arena, earmuffs will keep the noise level safe. Depending upon the style you choose, expect to pay anywhere from $10 on up for earmuffs that reduce noise by as much as 30 dB. Buy a pair of sweatbands Some active hearing aid wearers continue to work up a sweat outdoors while enjoying winter sports. You may also get caught outside during periods of heavy snow or freezing rain.

To minimize the amount of moisture your behind-the-ear hearing aids are exposed to as a result of perspirationâor precipitationâduring the winter months, invest in hearing aid sweatbands. These accessories are available in a variety of colors and sizes, with an average price of $20 per pair. Most of them are washable and slip on easily, acting as a moisture repellant and providing a windscreen for your microphone. If your hearing healthcare provider doesn't sell them, you can find them easily online.

Other wise ideas. Purchase a hearing aid drying kit or dehumidifier. Remove your hearing aid batteries and store your devices in this device every night. Some even sanitize hearing aids during storage.

Dehumidifiers range in price from $5 to $100 and can be purchased online, through your hearing care provider or in many drug stores. Use an umbrella in the rain and wear a raincoat with a hood. If you think your hearing aid has gotten wet, remove the battery immediately. Ear protection for winter Ears hurt from cold weather?.

Don't risk exostosis!. It turns out earmuffs, hats, and scarves are not just fashion accessories. Always keep your ears covered in very cold weather to reduce discomfort and the risk of frostbite. In fact, excessive exposure to extreme cold and wet conditions can lead to a rare condition known as exostosis.

Also known as âsurferâs earâ due to the condition being especially prevalent in those who spend time in or around cold water, exostosis results when exposure to the cold causes abnormal bone growths to appear on the bone surrounding the ear canal. As a result, the ear canal can become blocked, which increases the risk of due to trapped fluid. While the condition can be corrected surgically, avid skiers, snowmobilers or snowshoers should make sure to keep their ears warm, dry and covered to reduce their risk. Also known as âsurferâs earâ due to the condition being prevalent in those who spend time in or around cold water, exostosis results when exposure to the cold causes knobs of bony growth to appear on the bone surrounding the ear canal.

Can cold weather cause ringing in the ears?. Tinnitus and winter For some people, cold, wintry weather triggers their tinnitus, or ringing in the ears. Research shows that internet search terms for tinnitus go up in the winter!. Exactly why tinnitus is more common in winter, though, isn't well understood.

It's thought to be less about the frosty temperatures affecting our ears, and more about seasonal trends, such as more cold and flu s (which can increase pressure in the ear), unhealthy activities that can lead to high blood pressure (such as eating lots of salty foods), and increased rates of depression and stress. All of these things are known risk factors for tinnitus. Cold weather and clogged ears Changes in barometric pressure can leave your ears feeling clogged any time of year. Add in a seasonal respiratory swelling up your sinuses and you can feel downright miserable.

Read more about the causes of clogged ears. Why ear s are more common in winter During the winter, your ears are often colder, which means reduced circulation to provide a healthy blood supply. Meanwhile, ventolines and bacterial s are a lot more common in the winter. Put these together, and you have a heightened risk sinus s and a painful condition known as otitis media.

Otitis media, or an ear , causes painful swelling and inflammation of the middle ear. The swelling and can build up and increase the pressure behind the ear drum and block drainage from the Eustachian tube. Antibiotics can treat most ear s, but until the fluid is cleared, temporary hearing loss can result. Be sure to treat colds and flu immediately with rest, medication and plenty of fluids, and if you suspect an ear see a doctor immediately to prevent hearing damage.

Your doctor may prescribe medication and/or nasal sprays to help you get some relief. You can reduce your risk of ear s by keeping your ears warm and dry when you are outside in winter weather. Maintaining a healthy diet and exercising to improve blood circulation can also be helpful, especially in the colder months when resistance to is lower.

Sites for people with hearing loss The Hearing Health Foundation The Hearing http://blog.hiddenblessings.com/2010/09/21/hello-world/ Health Foundationâs mission buy ventolin nz is to prevent and cure hearing loss and tinnitus through research. They are the largest private funder of hearing research and have awarded millions of dollars since their organization in 1958. They maintain a hearing health blog and write a free magazine, Hearing Health Magazine, which keeps donors informed of the latest hearing health discoveries and provides a directory of annual summer camps for children and adults with hearing loss. Readers can learn about hearing loss, its buy ventolin nz prevention and current research on the site or get involved by sharing their hearing loss story and donating to the cause.

Hearing Journey If youâve received a cochlear implant or have hearing loss, you may want to join this community sponsored by Advance Bionics and the Bionic Ear Association. Readers can learn about cochlear implants and hearing loss, post questions for other readers to respond to or share stories about their hearing loss journey. The home page lists the names of current buy ventolin nz conversations along with the top categories of discussions. Readers must register to view the content.

Oticon Medical Friends If you or a loved one wears a Ponto bone-anchored hearing aid, you may already know about this patient-focused site. Oticon Medical Friends lets users connect with other Ponto users across buy ventolin nz the world. You must register to use the site. Oticon Medical also helps maintain the Bone Anchored Hearing Systems (BAHS) Blog, which features real patient stories and journeys.

Hearing Like Me This online buy ventolin nz community is sponsored by Phonak, a hearing device manufacturer. The corporate presence isnât overwhelming at all, instead giving space to people with hearing loss who want to connect with others who are experiencing the same challenges. Readers can view most of the information without registering unless they are planning to participate in the online forums. Deaf and Hard of Hearing The mission of this website, established in 2008, is to empower buy ventolin nz the hearing loss community by promoting confident social interaction and open communication.

The site also maintains a directory of summer camps and daycares for deaf and hard of hearing children, profiles a member of the month, and keeps a directory of audiologists, hearing care facilities and schools for the deaf and hard of hearing. No registration is required. However, readers are encouraged to register and receive access buy ventolin nz to chat live with other members. Bloggers and writers we love Smart Hearing Journalist and author Katherine Bouton has written several books about hearing loss, but in recent years she's also become an advocate and educator for people who are hearing-impaired.

This approach shines through on her blog, which she uses to provide "strategies, skills, and resources for living better with hearing loss." This is perhaps because she herself has hearing lossâshe uses a cochlear implant for one ear, and a hearing aid for the other. We highly recommend Katherine's blog for staying up-to-date on the real-world experiences of people buy ventolin nz with hearing loss. My Hearing Loss Story Carly, who has single-sided deafness, candidly shares the ups and downs of suddenly losing her hearing at her blog, Hearing Loss Story. She also delves into the practical, from tackling how to wear a mask with hearing loss during the asthma treatment ventolin, to her struggles with tinnitus.

Her warm and empathic voice are like a warm cup of tea on buy ventolin nz a rainy day. "I started this blog as a way to inform my friends and family about my progress, for anyone else who is going through a similar experience as me, or for anybody who is interested in learning about this type of hearing loss, and the way it can affect everyday life," Carly explains. Note. Carly also shared her experience with us using a buy ventolin nz CROS hearing aid.

My Thoughts You have to love an authentic person and Jennifer Gibson definitely fits that bill. She writes about growing up with severe hearing loss with honesty, passion and clarity. Her post about traveling with hearing loss not only gives hearing individuals a glimpse into what that might be like, it also gives those buy ventolin nz with hearing loss a few great tips for navigating on their own. Did we mention she is also a published author, graphic designer and illustrator?.

Her trilogy, "Sway, Compass and Destiny," follows the adventures of Jessie, a teenager with hearing loss. The award-winning books can be purchased on her website buy ventolin nz. Hands and Voices This group blog, facilitated by Karen Putz, is still going strong, with touching posts from parents with deaf or hard of hearing children. Recent topics include the parenting during the ventolin and parenting a child who has hearing loss and Down syndrome.

Lipreading Mom Since we last buy ventolin nz touched base with Shanna Groves, she has decided to scale back her book writing and public speaking activities. Thankfully, her faithful readers can still hear her strong, passionate voice about being a mom with hearing loss in her blog posts. ÂLipreadingMom.com is not about being an author or speaker,â she writes. ÂIt is a connection with other people who may live buy ventolin nz with hearing loss.

It is a connection with other parents and grandparents. Through the sharing of our everyday experiences, we can inspire, inform and entertain. In other words, we can make the world of parenting with buy ventolin nz a hearing loss not such a lonely place.â Living with Hearing Loss Hearing loss advocate and writer Shari Eberts updates her blog frequently, focusing on functional advice for people dealing with hearing impairments. The blog helps to "serve as an outlet for my experiences as well as a community for those dealing with similar issues," Shari says.

Her site is thorough and excellent, we recommend starting with her "most popular posts" page to get a sense of what you'll find. Cochlear Implant Life "The decision to have a Cochlear Implant is one that buy ventolin nz has changed my life. But, the path to achieving success with it did not happen overnight," writes Aiden Toominator, who manages the site and a related newsletter and YouTube channel. Cochlear Implant Life has helpful reviews of new products, stories from CI users and an online shop.

Rewiring Tinnitus Rewiring Tinnitus blogger and life coach Glenn Schweitzer has made a career out buy ventolin nz of a bad situation. A diagnosis of Meniere's disease and resulting tinnitus. Based on what he learned overcoming a challenging health situation, he now shares his experience and tips on his site. "If you suffer buy ventolin nz from tinnitus, I want you to know right now that there is so much hope.

No matter how severe your tinnitus is, or how bad things may seem, you can learn to live with your tinnitus, too," Glenn shares on his site. (Note. Glenn is also a Healthy Hearing columnist.) Share your story Got a hearing loss blog or vlog that you'd like featured on this list? buy ventolin nz. Please contact us.Cold wintry weather can cause hearing aid damage if proper precautions aren't taken.

While often hearing aids can be repaired, an ounce of prevention is worth a pound of cure. Here's some information on how cold weather buy ventolin nz and moisture can damage hearing aids, what to be aware of and how you can prevent weather damage. Also, find out about tinnitus and winter weather, and why clogged ears are more common in cold weather.Hearing aids, cold weather and moisture Moisture and condensation can quicklydamage hearing aids. Temperature extremes can be damaging to a hearing aid and its batteries.

The cold itself is not necessarily damaging, but the condensation that occurs due to temperature change can damage internal components buy ventolin nz. Even when it isn't snowing or raining, moisture is present because extreme temperature changes are common in the winter. For example, if you are walking outside and the temperature is 20 degrees Fahrenheit, you will almost certainly be bundled up from head to toe with a hat over your ears. But when you head indoors, it could be nearly buy ventolin nz 50 degrees warmer because the heat is on.

Even if you take off your coat and other winter gear right away, the temperature change can form condensation on your hearing aids. And maybe you were walking quickly and your head began to sweat, which could also damage your hearing aids and batteries. Signs of moisture buy ventolin nz damage Moisture can ruin the microphone and receiver of your hearing aids, as well as clog the earmold tubing and sound and cause corrosion. Here are some tell-tale signs that your hearing aids have been damaged.

Your hearing aid cuts out during loud noises. The sound buy ventolin nz fades or comes and goes. Everything you hear is punctuated by static. Sounds are unclear or seem distorted https://werkraum-hochberg.de/downloads/.

Your hearing aid completely stops working and then starts again. This might buy ventolin nz happen a few times. Hearing aid fixes If you think your hearing aids have been exposed to moisture, there are other things to check first. Such as.

Your hearing aid is turned on and (if buy ventolin nz you have one) the T-switch is in the right position. If you have disposable batteries, make sure they have been inserted correctly. Also, sometimes when batteries are dying, you will see some of the same signs as above. Check to make sure the battery buy ventolin nz is not corroded.

If it is, it will have a white powdery substance and should be thrown out immediately. The battery contacts, which are the points where the batteries touch the hearing aids. Clean them or remove moisture with a dry cotton swab buy ventolin nz. The earmold, to be sure it or the sound outlet are not clogged with wax.

Or, if you wear domes (a tiny cone that's inserted deep in the ear), make sure they are not damaged. More buy ventolin nz. How to troubleshoot common hearing aid problems If none of these things seem to be the issue, you may have moisture in your hearing aid. If you wear behind-the-ear (BTE) hearing aids, look in the tubing for moisture droplets.

If you wear earmolds, you can purchase an earmold puffer, which blows out any moisture, and consider having your earmolds fitted with a moisture dispersing tube buy ventolin nz. For in-the-ear (ITE) hearing aids, it's a little trickier to remove the moisture. If you don't already have one, purchase a hearing aid drying device and place your hearing aids in it immediately to hopefully dry them out and avoid damage. Not sure what kind of hearing aid you have? buy ventolin nz.

Check out our primer on hearing aid types and styles. Precautions for cold weather and hearing aids While moisture is hard to avoid in extreme cold, there are some precautions you can take in an attempt to keep your hearing aids dry and safe. Protect with earmuffs Earmuffs aren't only for keeping your ears warm while you're skating on the neighborhood pond or ice fishing with your favorite nephew buy ventolin nz. Specialized earmuffs are available specifically for protecting your ears from damaging noise.

Even if you already have hearing loss, further damage from noise is almost completely preventable by simply limiting your exposure. Noise-reduction earmuffs are not just buy ventolin nz for winter. In fact, they will come in handy many times throughout the year. Whether you're using your noisy lawnmower in the spring, enjoying a fireworks show in the summer and taking in a football game in a noisy arena, earmuffs will keep the noise level safe.

Depending upon the style you choose, expect to pay anywhere from $10 on up for earmuffs that reduce buy ventolin nz noise by as much as 30 dB. Buy a pair of sweatbands Some active hearing aid wearers continue to work up a sweat outdoors while enjoying winter sports. You may also get caught outside during periods of heavy snow or freezing rain. To minimize the amount of moisture your behind-the-ear hearing aids are exposed to as a result of perspirationâor buy ventolin nz precipitationâduring the winter months, invest in hearing aid sweatbands.

These accessories are available in a variety of colors and sizes, with an average price of $20 per pair. Most of them are washable and slip on easily, acting as a moisture repellant and providing a windscreen for your microphone. If your hearing healthcare buy ventolin nz provider doesn't sell them, you can find them easily online. Other wise ideas.

Purchase a hearing aid drying kit or dehumidifier. Remove your hearing aid batteries and store your devices in this device every buy ventolin nz night. Some even sanitize hearing aids during storage. Dehumidifiers range in price from $5 to $100 and can be purchased online, through your hearing care provider or in many drug stores.

Use an umbrella in buy ventolin nz the rain and wear a raincoat with a hood. If you think your hearing aid has gotten wet, remove the battery immediately. Ear protection for winter Ears hurt from cold weather?. Don't buy ventolin nz risk exostosis!.

It turns out earmuffs, hats, and scarves are not just fashion accessories. Always keep your ears covered in very cold weather to reduce discomfort and the risk of frostbite. In fact, excessive exposure to extreme cold and wet buy ventolin nz conditions can lead to a rare condition known as exostosis. Also known as âsurferâs earâ due to the condition being especially prevalent in those who spend time in or around cold water, exostosis results when exposure to the cold causes abnormal bone growths to appear on the bone surrounding the ear canal.

As a result, the ear canal can become blocked, which increases the risk of due to trapped fluid. While the condition can be corrected surgically, avid buy ventolin nz skiers, snowmobilers or snowshoers should make sure to keep their ears warm, dry and covered to reduce their risk. Also known as âsurferâs earâ due to the condition being prevalent in those who spend time in or around cold water, exostosis results when exposure to the cold causes knobs of bony growth to appear on the bone surrounding the ear canal. Can cold weather cause ringing in the ears?.

Tinnitus and winter For some people, cold, wintry buy ventolin nz weather triggers their tinnitus, or ringing in the ears. Research shows that internet search terms for tinnitus go up in the winter!. Exactly why tinnitus is more common in winter, though, isn't well understood. It's thought to be less about the frosty buy ventolin nz temperatures affecting our ears, and more about seasonal trends, such as more cold and flu s (which can increase pressure in the ear), unhealthy activities that can lead to high blood pressure (such as eating lots of salty foods), and increased rates of depression and stress.

All of these things are known risk factors for tinnitus. Cold weather and clogged ears Changes in barometric pressure can leave your ears feeling clogged any time of year. Add in a seasonal respiratory swelling up your buy ventolin nz sinuses and you can feel downright miserable. Read more about the causes of clogged ears.

Why ear s are more common in winter During the winter, your ears are often colder, which means reduced circulation to provide a healthy blood supply. Meanwhile, ventolines and bacterial buy ventolin nz s are a lot more common in the winter. Put these together, and you have a heightened risk sinus s and a painful condition known as otitis media. Otitis media, or an ear , causes painful swelling and inflammation of the middle ear.

The swelling and can build up and increase the pressure behind the ear drum and block drainage from the Eustachian tube. Antibiotics can treat most ear s, but until the fluid is cleared, temporary hearing loss can result. Be sure to treat colds and flu immediately with rest, medication and plenty of fluids, and if you suspect an ear see a doctor immediately to prevent hearing damage. Your doctor may prescribe medication and/or nasal sprays to help you get some relief.

You can reduce your risk of ear s by keeping your ears warm and dry when you are outside in winter weather. Maintaining a healthy diet and exercising to improve blood circulation can also be helpful, especially in the colder months when resistance to is lower. Whatever you do, don't put a cotton swab in your ear, as it can push hardened earwax further back into the ear.

What is ventolin evohaler used for

The transpopulation represents a vulnerable population segment both socially check and medically, with a higher incidence of mental health what is ventolin evohaler used for issues. During the asthma treatment outbreak, transgender persons have faced additional social, psychological and physical difficulties.1 what is ventolin evohaler used for 2 In Italy and in several other countries access to healthcare has been difficult or impossible thereby hindering the start or continuation of hormonal and psychological treatments. Furthermore, several planned gender-affirming surgeries have what is ventolin evohaler used for been postponed.

These obstacles may have caused an additional psychological burden given the positive effects of medical and surgical treatments on well-being, directly and indirectly, reducing stressors such as workplace discrimination and social inequalities.3 Some what is ventolin evohaler used for organisational aspects should also be considered. Binary gender policies may worsen inequalities and marginalisation of transgender subjects potentially increasing the risk of morbidity and mortality.As with the general population, during the lockdown, the Internet and social media were useful in reducing isolation and, in this particular population, were also what is ventolin evohaler used for relevant for keeping in touch with associations and healthcare facilities with the support of telemedicine services.4 Addressing the role of the telemedicine in the transpopulation, between May and June 2020 we conducted an anonymous web-based survey among transgenders living in Italy (ClinicalTrials.gov Identifier NCT04448418). Among the 108 respondents, with a mean age of 34.3Â±11.7 years, 73.1% were transmen and 26.9% transwomen and 88.9% were undergoing gender-affirming hormonal treatment (GAHT).

One in four what is ventolin evohaler used for subjects (24.1%) presented a moderate-to-severe impact of the ventolin event (Impact of Event Scale score â¥26). The availability of telematic endocrinological visit was associated with better Mental Health Scores in the 12-items Short Form Health Survey(SF-12) (p=0.030) and better IES (p=0.006).Our survey suggests a positive effect of telemedicine as the availability of telematic endocrinological consultations may have relieved the distress caused by the ventolin by offering the opportunity to avoid halting what is ventolin evohaler used for GAHT. In fact, deprivation of GAHT may result in several negative effects such as the increase in short-term self-medication and in depression and suicidal behaviour not what is ventolin evohaler used for only for those waiting for the start of treatment but also for those already using hormones.5 In conclusion, particular attention should be paid to vulnerable groups like the transpopulation who may pay a higher price during the ventolin.

The use of telemedicine for continuation and monitoring of GAHT may be an effective tool for mitigating the negative effects of the ventolin.AcknowledgmentsThe authors thank Julie Norbury for English copy editing.The British Medical Association recently published their report on the impact of asthma treatment on mental health in England, highlighting the urgent need for investment in mental health services and further recruitment of mental health staff.1 Like many others, they have predicted a substantial increase in demand on mental health what is ventolin evohaler used for services in the coming months. Their recommendations include a call for detailed workforce what is ventolin evohaler used for planning at local, national and system levels. This coincides with the publication of the âNHS People Planâ which also emphasised the need to maximise staff potential.2 The message from both is clear, it is time what is ventolin evohaler used for for Trusts to revise and improve how they use their multidisciplinary workforce, including non-medical prescribers (NMPs).Pharmacists have been able to register as independent prescribers since 20063 and as such, can work autonomously to prescribe any medicine for any medical condition within their areas of competency.4 There has been a slow uptake of pharmacists into this role5 and while a recent General Pharmaceutical Council survey found only a small increase between the number of active prescribers from 2013 (1.094) to 2019 (1.590), almost a quarter of prescribers included mental health within their prescribing practice.6 More recently, we have started to see increasing reports of the value of pharmacist independent prescribers in mental health services.7 8Pharmacists bring a unique perspective to patient consultation.

Their expertise in pharmacology and medicine use means they are ideally placed to help patients optimise their medicines treatment4 and to ensure that patients are involved in decisions about their medicines, taking into account individual views and preferences. This approach is consistent with the guidance on medicines optimisation from the National Institute for Health and Care Excellence9 and the Royal Pharmaceutical Society,10 and the Department of Healthâs drive to involve patients actively in clinical decisions.11 what is ventolin evohaler used for An increased focus on precision psychiatry in urging clinicians to tailor medicines to patients according to evidence about individualised risks and benefits.12 13 However, it takes time to discuss medicine choices and to explore individual beliefs about medicines. This is especially relevant in Psychiatry, where a large group of medicines (eg, antipsychotics) may have a wide range of what is ventolin evohaler used for potential side effects.

Prescribing pharmacists could provide what is ventolin evohaler used for leadership and support in tailoring medicines for patients, as part of the wider multidisciplinary team.10The recent news that Priadel, the most commonly used brand of lithium in the UK, is planned to be discontinued14 is another example where a new and unexpected burden on psychiatric services could be eased by sharing the workload with prescribing pharmacists. The Medicines and Healthcare Products Regulatory Agency recommends that patients should have an individualised medication review in order to switch from one brand of lithium to another.14 This is work that can be done by prescribing pharmacists who have an in-depth knowledge of the pharmacokinetics of lithium formulations.Importantly, this is a role that can be delivered using telepsychiatry and enhanced by what is ventolin evohaler used for the use of digital tools. Patients can what is ventolin evohaler used for meet pharmacists from the comfort of their own home using video conferencing.

Pharmacists can upload and share medicines information on the screen while discussing the benefits, risks and individual medication needs with each client. Increasingly organisations are using technology whereby prescriptions can be prepared electronically and sent securely to patients or their medicines providers.15We know from systematic reviews that NMPs in general are considered to provide a responsive, efficient and convenient service5 and to deliver similar prescribing outcomes as doctors.16 Medical professionals who have worked with NMPs have found that this support permits them to concentrate on clinical issues that require medical expertise.5 A patient survey carried out in 2013 indicated that independent nonâmedical prescribing was valued highly by patients and that generally there were few perceived differences in the care received from respondentsâ NMP and their usual doctor.17 The literature also suggests that an NMPâs role is more likely to flourish when linked to what is ventolin evohaler used for a strategic vision of NMPs within an National Health Service (NHS) Trust, along with a well-defined area of practice.18Mental health trusts are being asked to prepare for a surge in referrals and as part of this planning, they will need to ensure that they get the most out of their highly skilled workforce. There are active pharmacist prescribers in many trusts, however, this role is not yet commonplace.19 Health Education England has already identified that this is an important area of transformation for pharmacy and has called on mental health pharmacy teams to what is ventolin evohaler used for develop and share innovative ways of working.19 The âNHS People Planâ outlines a commitment to train 50 community-based specialist mental health pharmacists within the next 2âyears, along with a plan to extend the pharmacy foundation training to create a sustainable supply of prescribing pharmacists in future years.2We suggest that Mental Health Trusts should urgently develop prescribing roles for specialist mental health pharmacists, which are integrated within mental health teams.

In these what is ventolin evohaler used for roles, prescribing pharmacists can actively support their multidisciplinary colleagues in case discussion meetings. Furthermore, they should host regular medication review what is ventolin evohaler used for clinics, where patients can be referred to discuss their medicine options and, as advancements in precision therapeutics continue, have their treatment individually tailored to their needs. This is the way forward for a modern and patient-oriented NHS in the UK..

The transpopulation represents a vulnerable population segment both socially and medically, with buy ventolin nz a higher incidence of mental health issues. During the asthma treatment outbreak, transgender persons have faced additional social, psychological and physical difficulties.1 2 In Italy and in several other countries access to healthcare has been difficult or impossible thereby hindering the start or buy ventolin nz continuation of hormonal and psychological treatments. Furthermore, several planned gender-affirming surgeries have been buy ventolin nz postponed. These obstacles may have caused an additional psychological burden given the positive effects of medical and surgical treatments on well-being, directly and indirectly, reducing stressors such as buy ventolin nz workplace discrimination and social inequalities.3 Some organisational aspects should also be considered. Binary gender policies may worsen inequalities and marginalisation of transgender subjects potentially buy ventolin nz increasing the risk of morbidity and mortality.As with the general population, during the lockdown, the Internet and social media were useful in reducing isolation and, in this particular population, were also relevant for keeping in touch with associations and healthcare facilities with the support of telemedicine services.4 Addressing the role of the telemedicine in the transpopulation, between May and June 2020 we conducted an anonymous web-based survey among transgenders living in Italy (ClinicalTrials.gov Identifier NCT04448418).

Among the 108 respondents, with a mean age of 34.3Â±11.7 years, 73.1% were transmen and 26.9% transwomen and 88.9% were undergoing gender-affirming hormonal treatment (GAHT). One in buy ventolin nz four subjects (24.1%) presented a moderate-to-severe impact of the ventolin event (Impact of Event Scale score â¥26). The availability of telematic endocrinological visit was associated with better Mental Health Scores in the 12-items Short Form Health Survey(SF-12) (p=0.030) and better IES (p=0.006).Our survey suggests a positive effect of buy ventolin nz telemedicine as the availability of telematic endocrinological consultations may have relieved the distress caused by the ventolin by offering the opportunity to avoid halting GAHT. In fact, deprivation of GAHT may result in several negative effects such as the increase in short-term self-medication and in buy ventolin nz depression and suicidal behaviour not only for those waiting for the start of treatment but also for those already using hormones.5 In conclusion, particular attention should be paid to vulnerable groups like the transpopulation who may pay a higher price during the ventolin. The use of telemedicine for continuation and monitoring of GAHT may be an effective tool for mitigating the negative effects of the ventolin.AcknowledgmentsThe authors thank Julie Norbury for English copy editing.The British Medical Association recently published their report on the buy ventolin nz impact of asthma treatment on mental health in England, highlighting the urgent need for investment in mental health services and further recruitment of mental health staff.1 Like many others, they have predicted a substantial increase in demand on mental health services in the coming months.

Their recommendations include a buy ventolin nz call for detailed workforce planning at local, national and system levels. This coincides with the buy ventolin nz publication of the âNHS People Planâ which also emphasised the need to maximise staff potential.2 The message from both is clear, it is time for Trusts to revise and improve how they use their multidisciplinary workforce, including non-medical prescribers (NMPs).Pharmacists have been able to register as independent prescribers since 20063 and as such, can work autonomously to prescribe any medicine for any medical condition within their areas of competency.4 There has been a slow uptake of pharmacists into this role5 and while a recent General Pharmaceutical Council survey found only a small increase between the number of active prescribers from 2013 (1.094) to 2019 (1.590), almost a quarter of prescribers included mental health within their prescribing practice.6 More recently, we have started to see increasing reports of the value of pharmacist independent prescribers in mental health services.7 8Pharmacists bring a unique perspective to patient consultation. Their expertise in pharmacology and medicine use means they are ideally placed to help patients optimise their medicines treatment4 and to ensure that patients are involved in decisions about their medicines, taking into account individual views and preferences. This approach is consistent with the guidance on medicines optimisation from the National Institute for Health and Care Excellence9 and the Royal Pharmaceutical Society,10 and the Department of Healthâs drive to involve patients actively in clinical decisions.11 An increased focus on precision psychiatry in urging clinicians to tailor medicines to patients according to evidence about individualised risks and buy ventolin nz benefits.12 13 However, it takes time to discuss medicine choices and to explore individual beliefs about medicines. This is especially relevant in Psychiatry, where a large group of medicines (eg, antipsychotics) may have a wide buy ventolin nz range of potential side effects.

Prescribing pharmacists could provide leadership and support in tailoring medicines for patients, as part of the wider multidisciplinary team.10The recent buy ventolin nz news that Priadel, the most commonly used brand of lithium in the UK, is planned to be discontinued14 is another example where a new and unexpected burden on psychiatric services could be eased by sharing the workload with prescribing pharmacists. The Medicines and Healthcare Products Regulatory Agency recommends that patients should have an individualised medication review in order to switch from one brand of lithium to another.14 This is work that buy ventolin nz can be done by prescribing pharmacists who have an in-depth knowledge of the pharmacokinetics of lithium formulations.Importantly, this is a role that can be delivered using telepsychiatry and enhanced by the use of digital tools. Patients can meet pharmacists buy ventolin nz from the comfort of their own home using video conferencing. Pharmacists can upload and share medicines information on the screen while discussing the benefits, risks and individual medication needs with each client. Increasingly organisations are using technology whereby prescriptions can be prepared electronically and sent securely to patients or their medicines providers.15We know from systematic reviews that buy ventolin nz NMPs in general are considered to provide a responsive, efficient and convenient service5 and to deliver similar prescribing outcomes as doctors.16 Medical professionals who have worked with NMPs have found that this support permits them to concentrate on clinical issues that require medical expertise.5 A patient survey carried out in 2013 indicated that independent nonâmedical prescribing was valued highly by patients and that generally there were few perceived differences in the care received from respondentsâ NMP and their usual doctor.17 The literature also suggests that an NMPâs role is more likely to flourish when linked to a strategic vision of NMPs within an National Health Service (NHS) Trust, along with a well-defined area of practice.18Mental health trusts are being asked to prepare for a surge in referrals and as part of this planning, they will need to ensure that they get the most out of their highly skilled workforce.

There are active pharmacist prescribers in many trusts, however, this role is not yet commonplace.19 Health Education England has already identified that this is an important area of transformation for pharmacy and has called on mental health buy ventolin nz pharmacy teams to develop and share innovative ways of working.19 The âNHS People Planâ outlines a commitment to train 50 community-based specialist mental health pharmacists within the next 2âyears, along with a plan to extend the pharmacy foundation training to create a sustainable supply of prescribing pharmacists in future years.2We suggest that Mental Health Trusts should urgently develop prescribing roles for specialist mental health pharmacists, which are integrated within mental health teams. In these roles, buy ventolin nz prescribing pharmacists can actively support their multidisciplinary colleagues in case discussion meetings. Furthermore, they should host regular medication review clinics, where patients can be referred to discuss their medicine options and, as advancements in precision therapeutics continue, have their buy ventolin nz treatment individually tailored to their needs. This is the way forward for a modern and patient-oriented NHS in the UK..

Ventolin pill price

Participants Figure Visit Website 1 ventolin pill price. Figure 1 ventolin pill price. Enrollment and Randomization.

The diagram represents all enrolled participants through ventolin pill price November 14, 2020. The safety subset (those with a median of 2 months of follow-up, in accordance with application requirements for Emergency Use Authorization) is based on an October 9, 2020, data cut-off date. The further ventolin pill price procedures that one participant in the placebo group declined after dose 2 (lower right corner of the diagram) were those involving collection of blood and nasal swab samples.Table 1.

Table 1. Demographic Characteristics of the Participants in the ventolin pill price Main Safety Population. Between July 27, 2020, and November 14, 2020, a total of 44,820 persons were screened, and 43,548 persons 16 years of age or older underwent randomization at 152 sites worldwide (United States, 130 sites.

Argentina, 1 ventolin pill price. Brazil, 2. South Africa, ventolin pill price 4.

Germany, 6 ventolin pill price. And Turkey, 9) in the phase 2/3 portion of the trial. A total ventolin pill price of 43,448 participants received injections.

21,720 received BNT162b2 and 21,728 received placebo (Figure 1). At the data cut-off date of October ventolin pill price 9, a total of 37,706 participants had a median of at least 2 months of safety data available after the second dose and contributed to the main safety data set. Among these 37,706 participants, 49% were female, 83% were White, 9% were Black or African American, 28% were Hispanic or Latinx, 35% were obese (body mass index [the weight in kilograms divided by the square of the height in meters] of at least 30.0), and 21% had at least one coexisting condition.

The median age was 52 years, and 42% of participants ventolin pill price were older than 55 years of age (Table 1 and Table S2). Safety Local Reactogenicity Figure 2. Figure 2 ventolin pill price.

Local and Systemic Reactions Reported within 7 Days after Injection of BNT162b2 or Placebo, According to Age Group. Data on local and systemic reactions and use of medication were collected with electronic diaries from participants in the reactogenicity ventolin pill price subset (8,183 participants) for 7 days after each vaccination. Solicited injection-site (local) ventolin pill price reactions are shown in Panel A.

Pain at the injection site was assessed according to the following scale. Mild, does not interfere ventolin pill price with activity. Moderate, interferes with activity.

Severe, prevents daily activity ventolin pill price. And grade 4, emergency department visit or hospitalization. Redness and swelling were measured according to the following scale ventolin pill price.

Mild, 2.0 to 5.0 cm in diameter. Moderate, >5.0 to 10.0 cm in diameter ventolin pill price. Severe, >10.0 cm in diameter.

And grade 4, necrosis or exfoliative dermatitis (for ventolin pill price redness) and necrosis (for swelling). Systemic events and medication use are shown in ventolin pill price Panel B. Fever categories are designated in the key.

Medication use was not ventolin pill price graded. Additional scales were as follows. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint ventolin pill price pain (mild.

Does not interfere with activity. Moderate. Some interference with activity.

Or severe. Prevents daily activity), vomiting (mild. 1 to 2 times in 24 hours.

Moderate. >2 times in 24 hours. Or severe.

Requires intravenous hydration), and diarrhea (mild. 2 to 3 loose stools in 24 hours. Moderate.

4 to 5 loose stools in 24 hours. Or severe. 6 or more loose stools in 24 hours).

Grade 4 for all events indicated an emergency department visit or hospitalization. Ð¸ bars represent 95% confidence intervals, and numbers above the ð¸ bars are the percentage of participants who reported the specified reaction.The reactogenicity subset included 8183 participants. Overall, BNT162b2 recipients reported more local reactions than placebo recipients.

Among BNT162b2 recipients, mild-to-moderate pain at the injection site within 7 days after an injection was the most commonly reported local reaction, with less than 1% of participants across all age groups reporting severe pain (Figure 2). Pain was reported less frequently among participants older than 55 years of age (71% reported pain after the first dose. 66% after the second dose) than among younger participants (83% after the first dose.

In general, local reactions were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Systemic Reactogenicity Systemic events were reported more often by younger treatment recipients (16 to 55 years of age) than by older treatment recipients (more than 55 years of age) in the reactogenicity subset and more often after dose 2 than dose 1 (Figure 2B). The most commonly reported systemic events were fatigue and headache (59% and 52%, respectively, after the second dose, among younger treatment recipients.

51% and 39% among older recipients), although fatigue and headache were also reported by many placebo recipients (23% and 24%, respectively, after the second dose, among younger treatment recipients. 17% and 14% among older recipients). The frequency of any severe systemic event after the first dose was 0.9% or less.

Severe systemic events were reported in less than 2% of treatment recipients after either dose, except for fatigue (in 3.8%) and headache (in 2.0%) after the second dose. Fever (temperature, â¥38Â°C) was reported after the second dose by 16% of younger treatment recipients and by 11% of older recipients. Only 0.2% of treatment recipients and 0.1% of placebo recipients reported fever (temperature, 38.9 to 40Â°C) after the first dose, as compared with 0.8% and 0.1%, respectively, after the second dose.

Two participants each in the treatment and placebo groups reported temperatures above 40.0Â°C. Younger treatment recipients were more likely to use antipyretic or pain medication (28% after dose 1. 45% after dose 2) than older treatment recipients (20% after dose 1.

No difference was noted between the BNT162b2 group and the placebo group. Adverse Events Adverse event analyses are provided for all enrolled 43,252 participants, with variable follow-up time after dose 1 (Table S3). More BNT162b2 recipients than placebo recipients reported any adverse event (27% and 12%, respectively) or a related adverse event (21% and 5%).

This distribution largely reflects the inclusion of transient reactogenicity events, which were reported as adverse events more commonly by treatment recipients than by placebo recipients. Sixty-four treatment recipients (0.3%) and 6 placebo recipients (<0.1%) reported lymphadenopathy. Few participants in either group had severe adverse events, serious adverse events, or adverse events leading to withdrawal from the trial.

Four related serious adverse events were reported among BNT162b2 recipients (shoulder injury related to treatment administration, right axillary lymphadenopathy, paroxysmal ventricular arrhythmia, and right leg paresthesia). Two BNT162b2 recipients died (one from arteriosclerosis, one from cardiac arrest), as did four placebo recipients (two from unknown causes, one from hemorrhagic stroke, and one from myocardial infarction). No deaths were considered by the investigators to be related to the treatment or placebo.

No asthma treatmentâassociated deaths were observed. No stopping rules were met during the reporting period. Safety monitoring will continue for 2 years after administration of the second dose of treatment.

Efficacy Table 2. Table 2. treatment Efficacy against asthma treatment at Least 7 days after the Second Dose.

Table 3. Table 3. treatment Efficacy Overall and by Subgroup in Participants without Evidence of before 7 Days after Dose 2.

Figure 3. Figure 3. Efficacy of BNT162b2 against asthma treatment after the First Dose.

Shown is the cumulative incidence of asthma treatment after the first dose (modified intention-to-treat population). Each symbol represents asthma treatment cases starting on a given day. Filled symbols represent severe asthma treatment cases.

Some symbols represent more than one case, owing to overlapping dates. The inset shows the same data on an enlarged y axis, through 21 days. Surveillance time is the total time in 1000 person-years for the given end point across all participants within each group at risk for the end point.

Table 2). Among participants with and those without evidence of prior SARS CoV-2 , 9 cases of asthma treatment at least 7 days after the second dose were observed among treatment recipients and 169 among placebo recipients, corresponding to 94.6% treatment efficacy (95% CI, 89.9 to 97.3). Supplemental analyses indicated that treatment efficacy among subgroups defined by age, sex, race, ethnicity, obesity, and presence of a coexisting condition was generally consistent with that observed in the overall population (Table 3 and Table S4).

treatment efficacy among participants with hypertension was analyzed separately but was consistent with the other subgroup analyses (treatment efficacy, 94.6%. 95% CI, 68.7 to 99.9. Case split.

BNT162b2, 2 cases. Placebo, 44 cases). Figure 3 shows cases of asthma treatment or severe asthma treatment with onset at any time after the first dose (mITT population) (additional data on severe asthma treatment are available in Table S5).

Between the first dose and the second dose, 39 cases in the BNT162b2 group and 82 cases in the placebo group were observed, resulting in a treatment efficacy of 52% (95% CI, 29.5 to 68.4) during this interval and indicating early protection by the treatment, starting as soon as 12 days after the first dose.Baseline Anti-Spike IgG Assays and PCR Testing Rates Table 1. Table 1. Demographic Characteristics and asthma PCR Testing for 12,541 Health Care Workers According to asthma Anti-Spike IgG Status.

Of 1265 seropositive health care workers, 864 (68%) recalled having had symptoms consistent with those of asthma disease 2019 (asthma treatment), including symptoms that preceded the widespread availability of PCR testing for asthma. 466 (37%) had had a previous PCR-confirmed asthma , of which 262 were symptomatic. Fewer seronegative health care workers (2860 [25% of the 11,364 who were seronegative]) reported prebaseline symptoms, and 24 (all symptomatic, 0.2%) were previously PCR-positive.

The median age of seronegative and seropositive health care workers was 38 years (interquartile range, 29 to 49). Health care workers were followed for a median of 200 days (interquartile range, 180 to 207) after a negative antibody test and for 139 days at risk (interquartile range, 117 to 147) after a positive antibody test. Rates of symptomatic PCR testing were similar in seronegative and seropositive health care workers.

8.7 and 8.0 tests per 10,000 days at risk, respectively (rate ratio, 0.92. 95% confidence interval [CI], 0.77 to 1.10). A total of 8850 health care workers had at least one postbaseline asymptomatic screening test.

Seronegative health care workers attended asymptomatic screening more frequently than seropositive health care workers (141 vs. 108 per 10,000 days at risk, respectively. Rate ratio, 0.76.

Of 1265 health care workers with a positive anti-spike IgG assay, 2 had a positive PCR test (0.13 per 10,000 days at risk), and both workers were asymptomatic when tested. The incidence rate ratio for positive PCR tests in seropositive workers was 0.12 (95% CI, 0.03 to 0.47. P=0.002).

The incidence of PCR-confirmed symptomatic in seronegative health care workers was 0.60 per 10,000 days at risk, whereas there were no confirmed symptomatic s in seropositive health care workers. No PCR-positive results occurred in 24 seronegative, previously PCR-positive health care workers. Seroconversion occurred in 5 of these workers during follow-up.

Figure 1. Figure 1. Observed Incidence of asthmaâPositive PCR Results According to Baseline Anti-Spike IgG Antibody Status.

The incidence of polymerase-chain-reaction (PCR) tests that were positive for asthma during the period from April through November 2020 is shown per 10,000 days at risk among health care workers according to their antibody status at baseline. In seronegative health care workers, 1775 PCR tests (8.7 per 10,000 days at risk) were undertaken in symptomatic persons and 28,878 (141 per 10,000 days at risk) in asymptomatic persons. In seropositive health care workers, 126 (8.0 per 10,000 days at risk) were undertaken in symptomatic persons and 1704 (108 per 10,000 days at risk) in asymptomatic persons.

RR denotes rate ratio.Incidence varied by calendar time (Figure 1), reflecting the first (March through April) and second (October and November) waves of the ventolin in the United Kingdom, and was consistently higher in seronegative health care workers. After adjustment for age, gender, and month of testing (Table S1) or calendar time as a continuous variable (Fig. S2), the incidence rate ratio in seropositive workers was 0.11 (95% CI, 0.03 to 0.44.

P=0.002). Results were similar in analyses in which follow-up of both seronegative and seropositive workers began 60 days after baseline serologic assay. With a 90-day window after positive serologic assay or PCR testing.

And after random removal of PCR results for seronegative health care workers to match asymptomatic testing rates in seropositive health care workers (Tables S2 through S4). The incidence of positive PCR tests was inversely associated with anti-spike antibody titers, including titers below the positive threshold (P<0.001 for trend) (Fig. S3A).

Anti-Nucleocapsid IgG Status With anti-nucleocapsid IgG used as a marker for prior in 12,666 health care workers (Fig. S1B and Table S5), 226 of 11,543 (1.10 per 10,000 days at risk) seronegative health care workers tested PCR-positive, as compared with 2 of 1172 (0.13 per 10,000 days at risk) antibody-positive health care workers (incidence rate ratio adjusted for calendar time, age, and gender, 0.11. 95% CI, 0.03 to 0.45.

P=0.002) (Table S6). The incidence of PCR-positive results fell with increasing anti-nucleocapsid antibody titers (P<0.001 for trend) (Fig. S3B).

A total of 12,479 health care workers had both anti-spike and anti-nucleocapsid baseline results (Fig. S1C and Tables S7 and S8). 218 of 11,182 workers (1.08 per 10,000 days at risk) with both immunoassays negative had subsequent PCR-positive tests, as compared with 1 of 1021 workers (0.07 per 10,000 days at risk) with both baseline assays positive (incidence rate ratio, 0.06.

95% CI, 0.01 to 0.46) and 2 of 344 workers (0.49 per 10,000 days at risk) with mixed antibody assay results (incidence rate ratio, 0.42. 95% CI, 0.10 to 1.69). Seropositive Health Care Workers with PCR-Positive Results Table 2.

Table 2. Demographic, Clinical, and Laboratory Characteristics of Health Care Workers with Possible asthma Re. Three seropositive health care workers subsequently had PCR-positive tests for asthma (one with anti-spike IgG only, one with anti-nucleocapsid IgG only, and one with both antibodies).

The time between initial symptoms or seropositivity and subsequent positive PCR testing ranged from 160 to 199 days. Information on the workersâ clinical histories and on PCR and serologic testing results is shown in Table 2 and Figure S4. Only the health care worker with both antibodies had a history of PCR-confirmed symptomatic that preceded serologic testing.

After five negative PCR tests, this worker had one positive PCR test (low viral load. Cycle number, 21 [approximate equivalent cycle threshold, 31]) at day 190 after while the worker was asymptomatic, with subsequent negative PCR tests 2 and 4 days later and no subsequent rise in antibody titers. If this workerâs single PCR-positive result was a false positive, the incidence rate ratio for PCR positivity if anti-spike IgGâseropositive would fall to 0.05 (95% CI, 0.01 to 0.39) and if anti-nucleocapsid IgGâseropositive would fall to 0.06 (95% CI, 0.01 to 0.40).

The National Institute of Allergy and Infectious Diseases and Leidos Biomedical Researchfor the INSIGHT Network. The National Heart, Lung, and Blood Institute and the Research Triangle Institute for the PETAL (Prevention and Early Treatment of Acute Lung Injury) Network and the Cardiothoracic Surgical Trials Network. And the U.S.

Department of Veterans Affairs and grants from the governments of Denmark (no. 126 from the National Research Foundation), Australia (from the National Health and Medical Research Council), and the United Kingdom (MRC_UU_12023/23 from the Medical Research Council). Trial medications were donated by Gilead Sciences and Eli Lilly.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. The members of the writing committee are as follows. Prof.

Jens D. Lundgren, M.D., D.M.Sc., Birgit Grund, Ph.D., Christina E. Barkauskas, M.D., Thomas L.

Holland, M.D., Robert L. Gottlieb, M.D., Ph.D., Uriel Sandkovsky, M.D., Samuel M. Brown, M.D., Kirk U.

Knowlton, M.D., Wesley H. Self, M.D., M.P.H., D. Clark Files, M.D., Mamta K.

Jain, M.D., M.P.H., Thomas Benfield, M.D., D.M.Sc., Michael E. Bowdish, M.D., Bradley G. Leshnower, M.D., Jason V.

Baker, M.D., Jens-Ulrik Jensen, M.D., Ph.D., Edward M. Gardner, M.D., Adit A. Ginde, M.D., M.P.H., Estelle S.

Harris, M.D., Isik S. Johansen, M.D., D.M.Sc., Norman Markowitz, M.D., Michael A. Matthay, M.D., Lars Ãstergaard, M.D., Ph.D., D.M.Sc., Christina C.

Chang, M.D., Ph.D., Victoria J. Davey, Ph.D., M.P.H., Anna Goodman, F.R.C.P., D.Phil., Elizabeth S. Higgs, M.D., Daniel D.

Murray, Ph.D., Thomas A. Murray, Ph.D., Roger Paredes, M.D., Ph.D., Mahesh K.B. Parmar, Ph.D., Andrew N.

Phillips, Ph.D., Cavan Reilly, Ph.D., Shweta Sharma, M.S., Robin L. Dewar, Ph.D., Marc Teitelbaum, M.D., Deborah Wentworth, M.P.H., Huyen Cao, M.D., Paul Klekotka, M.D., Ph.D., Abdel G. Babiker, Ph.D., Annetine C.

Gelijns, Ph.D., Virginia L. Kan, M.D., Mark N. Polizzotto, M.D., Ph.D., B.

Taylor Thompson, M.D., H. Clifford Lane, M.D., and James D. Neaton, Ph.D.This article was published on December 22, 2020, at NEJM.org.A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.We thank the members of the TICO data and safety monitoring board â Merlin L.

Robb, M.D. (chair), David Glidden, Ph.D., Graeme A. Meintjes, M.B., Ch.B., Ph.D., Barbara E.

Murray, M.D., Stuart Campbell Ray, M.D., Valeria Cavalcanti Rolla, M.D., Ph.D., Haroon Saloojee, M.B., B.Ch., Anastasios A. Tsiatis, Ph.D., Paul A. Volberding, M.D., Jonathan Kimmelman, Ph.D., and Sally Hunsberger, Ph.D.

(executive secretary) â for their review of the protocol and their guidance based on interim reviews of the data.Trial Design We are conducting an ongoing operationally seamless (continual enrollment), multicenter, randomized, double-blind, placebo-controlled, phase 1â3 clinical trial involving symptomatic, nonhospitalized patients with asthma treatment. The interim analysis we describe here involved the first 275 patients enrolled during the phase 1â2 portion of the trial and was conducted to assess the safety and efficacy of REGN-COV2, to gain an understanding of the natural history of asthma treatment in outpatients, and to refine the end points for subsequent analyses. The trial continues to recruit beyond the first 275 patients for whom data are described in this report.

The results for the key primary and secondary prespecified end points are planned to be reported at trial completion. The data cutoff for this interim analysis was September 4, 2020. In the phase 1â2 portion of the trial reported here, all patients were randomly assigned (1:1:1) to receive placebo, REGN-COV2 at a dose of 2.4 g (low dose), or REGN-COV2 at a dose of 8.0 g (high dose) (Fig.

S1 in the Supplementary Appendix, available with the full text of this article at NEJM.org). Each of the two antibodies that make up REGN-COV2 â casirivimab (REGN10933) and imdevimab (REGN10987) â is given in equal doses in the cocktail. Details of the randomization stratification are provided in the Supplementary Appendix.

All patients had to have a confirmed asthma , with a asthmaâpositive test result received no more than 72 hours before randomization and symptom onset no more than 7 days before randomization. The full list of inclusion and exclusion criteria are provided in the Supplementary Appendix. The protocol is available at NEJM.org.

An assay for antiâasthma antibodies was performed in all patients. Because these results were not available at randomization, patients underwent randomization regardless of their baseline serologic status, and the analyses were prespecified to first evaluate efficacy in the subgroup of patients who were serum antibodyânegative â that is, those patients who tested negative for all three of the following antibodies. IgA anti-S1 domain of spike protein, IgG anti-S1 domain of spike protein, and IgG anti-nucleocapsid protein.

Patients who were positive for any one of these antibodies were designated as serum antibodyâpositive. A small number of patients could not be evaluated or had borderline results (unknown serum antibody status). Analyses involving these patients were conducted but are not reported here.

Intervention and Assessments At baseline (day 1), REGN-COV2 (at the high dose or low dose) or saline placebo was administered intravenously in a 250-ml normal saline solution over a period of 1 hour. The schedule of assessments is described in the protocol, along with a summary of protocol amendments. Quantitative virologic analysis, asthma serum antibody testing, and measurement of the two components of REGN-COV2 in serum are described in the Supplementary Appendix.

The change in viral load from baseline to various days during the trial was an additional prespecified virologic end point, and the change in absolute viral load (measured in copies per milliliter) was a post hoc virologic end point. The prespecified key clinical end point was the percentage of patients with at least one asthma treatmentârelated medically attended visit through day 29 in both the serum antibodyânegative subgroup and the overall trial population. Medically attended visits could include telemedicine visits, in-person physician visits, urgent care or emergency department visits, and hospitalization.

For assessments of safety, we collected data on adverse events that occurred or worsened during the observation period (grade 3 and 4. Phase 1 only), serious adverse events that occurred or worsened during the observation period (phases 1 and 2), and the following adverse events of special interest (phases 1 and 2). Grade 2 or higher hypersensitivity or infusion-related reactions.

Pharmacokinetic variables included the concentrations of casirivimab and imdevimab in serum over time. Trial Oversight Regeneron designed the trial. Gathered the data, together with the trial investigators.

And analyzed the data. Regeneron and the authors vouch for the accuracy and completeness of the data, and Regeneron vouches for the fidelity of the trial to the protocol. The authors provided critical feedback and final approval of the manuscript for submission.

An independent data and safety monitoring committee periodically monitored unblinded data to make recommendations about trial modification and termination. The independent committee and, separately, Regeneron physicians who were aware of the treatment-group assignments and were not involved in the conduct of the trial performed interim data reviews for adapting the trial design. The trial was conducted in accordance with the principles of the Declaration of Helsinki, International Council for Harmonisation Good Clinical Practice guidelines, and applicable regulatory requirements.

The local institutional review board or ethics committee at each study center oversaw trial conduct and documentation. One center was found to have violations of Good Clinical Practice guidelines (not related to the collection of data on efficacy or safety end points) and was withdrawn from the trial after analyses had been completed. All the patients provided written informed consent before participating in the trial.

Statistical Analysis The statistical analysis plan for the presented analysis was finalized before database lock and unblinding. The full analysis set included the first 275 patients with asthma treatment symptoms who underwent randomization in the combined phase 1â2 portions of the trial. A sample of 275 patients (72 in phase 1 and 203 in phase 2) was considered sufficient for the assessment of virologic efficacy, clinical trends, and safety for the purpose of informing subsequent analyses.

Because patients could enroll if they had tested positive for asthma no more than 72 hours before randomization, patients who tested negative by qualitative RT-PCR at baseline (lower limit of detection, 714 copies per milliliter [2.85 log10 copies per milliliter]) were excluded from analyses of virologic end points in a modified full analysis set. Because of the a priori hypothesis that patients whose immune system was already clearing the ventolin were unlikely to benefit from additional antibody therapy, analyses were prespecified in the statistical analysis plan to focus on the serum antibodyânegative subgroup. All patients who received REGN-COV2 or placebo were included in the safety population.

The time-weighted average change from baseline (day 1) through day 7 was calculated for each patient as the area under the concentrationâtime curve, with the use of the linear trapezoidal rule for change from baseline divided by the time interval of the observation period. This end point was analyzed with an analysis-of-covariance model with treatment group, risk factor, and baseline serum antibody status as fixed effects and baseline viral load and treatment groupâbyâbaseline viral load as covariates. Confidence intervals in this report were not adjusted for multiplicity.

Statistical analyses were performed with SAS software, version 9.4 or higher (SAS Institute). Additional statistical and pharmacokinetic analysis methods are described in the Supplementary Appendix..

Participants Figure http://www.finedesigncontracting.com/?page_id=23 1 buy ventolin nz. Figure 1 buy ventolin nz. Enrollment and Randomization. The diagram represents all enrolled participants through November 14, 2020 buy ventolin nz. The safety subset (those with a median of 2 months of follow-up, in accordance with application requirements for Emergency Use Authorization) is based on an October 9, 2020, data cut-off date.

The further procedures that one participant in the placebo group declined after dose 2 (lower right corner of buy ventolin nz the diagram) were those involving collection of blood and nasal swab samples.Table 1. Table 1. Demographic Characteristics of the Participants buy ventolin nz in the Main Safety Population. Between July 27, 2020, and November 14, 2020, a total of 44,820 persons were screened, and 43,548 persons 16 years of age or older underwent randomization at 152 sites worldwide (United States, 130 sites. Argentina, 1 buy ventolin nz.

Brazil, 2. South Africa, buy ventolin nz 4. Germany, 6 buy ventolin nz. And Turkey, 9) in the phase 2/3 portion of the trial. A total of buy ventolin nz 43,448 participants received injections.

21,720 received BNT162b2 and 21,728 received placebo (Figure 1). At the data cut-off date of October 9, a total of 37,706 participants had a median of at least 2 buy ventolin nz months of safety data available after the second dose and contributed to the main safety data set. Among these 37,706 participants, 49% were female, 83% were White, 9% were Black or African American, 28% were Hispanic or Latinx, 35% were obese (body mass index [the weight in kilograms divided by the square of the height in meters] of at least 30.0), and 21% had at least one coexisting condition. The median age was 52 years, and 42% of buy ventolin nz participants were older than 55 years of age (Table 1 and Table S2). Safety Local Reactogenicity Figure 2.

Figure 2 buy ventolin nz. Local and Systemic Reactions Reported within 7 Days after Injection of BNT162b2 or Placebo, According to Age Group. Data on local and systemic reactions and use of medication were collected with electronic diaries from participants in the reactogenicity subset (8,183 participants) for 7 days after each buy ventolin nz vaccination. Solicited injection-site (local) reactions are shown in Panel A buy ventolin nz. Pain at the injection site was assessed according to the following scale.

Mild, does not buy ventolin nz interfere with activity. Moderate, interferes with activity. Severe, prevents daily buy ventolin nz activity. And grade 4, emergency department visit or hospitalization. Redness and buy ventolin nz swelling were measured according to the following scale.

Mild, 2.0 to 5.0 cm in diameter. Moderate, >5.0 to buy ventolin nz 10.0 cm in diameter. Severe, >10.0 cm in diameter. And grade 4, buy ventolin nz necrosis or exfoliative dermatitis (for redness) and necrosis (for swelling). Systemic events and buy ventolin nz medication use are shown in Panel B.

Fever categories are designated in the key. Medication use buy ventolin nz was not graded. Additional scales were as follows. Fatigue, headache, chills, new buy ventolin nz or worsened muscle pain, new or worsened joint pain (mild. Does not interfere with activity.

Moderate. Some interference with activity. Or severe. Prevents daily activity), vomiting (mild. 1 to 2 times in 24 hours.

Moderate. >2 times in 24 hours. Or severe. Requires intravenous hydration), and diarrhea (mild. 2 to 3 loose stools in 24 hours.

Moderate. 4 to 5 loose stools in 24 hours. Or severe. 6 or more loose stools in 24 hours). Grade 4 for all events indicated an emergency department visit or hospitalization.

Ð¸ bars represent 95% confidence intervals, and numbers above the ð¸ bars are the percentage of participants who reported the specified reaction.The reactogenicity subset included 8183 participants. Overall, BNT162b2 recipients reported more local reactions than placebo recipients. Among BNT162b2 recipients, mild-to-moderate pain at the injection site within 7 days after an injection was the most commonly reported local reaction, with less than 1% of participants across all age groups reporting severe pain (Figure 2). Pain was reported less frequently among participants older than 55 years of age (71% reported pain after the first dose. 66% after the second dose) than among younger participants (83% after the first dose.

78% after the second dose). A noticeably lower percentage of participants reported injection-site redness or swelling. The proportion of participants reporting local reactions did not increase after the second dose (Figure 2A), and no participant reported a grade 4 local reaction. In general, local reactions were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Systemic Reactogenicity Systemic events were reported more often by younger treatment recipients (16 to 55 years of age) than by older treatment recipients (more than 55 years of age) in the reactogenicity subset and more often after dose 2 than dose 1 (Figure 2B).

The most commonly reported systemic events were fatigue and headache (59% and 52%, respectively, after the second dose, among younger treatment recipients. 51% and 39% among older recipients), although fatigue and headache were also reported by many placebo recipients (23% and 24%, respectively, after the second dose, among younger treatment recipients. 17% and 14% among older recipients). The frequency of any severe systemic event after the first dose was 0.9% or less. Severe systemic events were reported in less than 2% of treatment recipients after either dose, except for fatigue (in 3.8%) and headache (in 2.0%) after the second dose.

Fever (temperature, â¥38Â°C) was reported after the second dose by 16% of younger treatment recipients and by 11% of older recipients. Only 0.2% of treatment recipients and 0.1% of placebo recipients reported fever (temperature, 38.9 to 40Â°C) after the first dose, as compared with 0.8% and 0.1%, respectively, after the second dose. Two participants each in the treatment and placebo groups reported temperatures above 40.0Â°C. Younger treatment recipients were more likely to use antipyretic or pain medication (28% after dose 1. 45% after dose 2) than older treatment recipients (20% after dose 1.

38% after dose 2), and placebo recipients were less likely (10 to 14%) than treatment recipients to use the medications, regardless of age or dose. Systemic events including fever and chills were observed within the first 1 to 2 days after vaccination and resolved shortly thereafter. Daily use of the electronic diary ranged from 90 to 93% for each day after the first dose and from 75 to 83% for each day after the second dose. No difference was noted between the BNT162b2 group and the placebo group. Adverse Events Adverse event analyses are provided for all enrolled 43,252 participants, with variable follow-up time after dose 1 (Table S3).

More BNT162b2 recipients than placebo recipients reported any adverse event (27% and 12%, respectively) or a related adverse event (21% and 5%). This distribution largely reflects the inclusion of transient reactogenicity events, which were reported as adverse events more commonly by treatment recipients than by placebo recipients. Sixty-four treatment recipients (0.3%) and 6 placebo recipients (<0.1%) reported lymphadenopathy. Few participants in either group had severe adverse events, serious adverse events, or adverse events leading to withdrawal from the trial. Four related serious adverse events were reported among BNT162b2 recipients (shoulder injury related to treatment administration, right axillary lymphadenopathy, paroxysmal ventricular arrhythmia, and right leg paresthesia).

Two BNT162b2 recipients died (one from arteriosclerosis, one from cardiac arrest), as did four placebo recipients (two from unknown causes, one from hemorrhagic stroke, and one from myocardial infarction). No deaths were considered by the investigators to be related to the treatment or placebo. No asthma treatmentâassociated deaths were observed. No stopping rules were met during the reporting period. Safety monitoring will continue for 2 years after administration of the second dose of treatment.

Efficacy Table 2. Table 2. treatment Efficacy against asthma treatment at Least 7 days after the Second Dose. Table 3. Table 3.

treatment Efficacy Overall and by Subgroup in Participants without Evidence of before 7 Days after Dose 2. Figure 3. Figure 3. Efficacy of BNT162b2 against asthma treatment after the First Dose. Shown is the cumulative incidence of asthma treatment after the first dose (modified intention-to-treat population).

Each symbol represents asthma treatment cases starting on a given day. Filled symbols represent severe asthma treatment cases. Some symbols represent more than one case, owing to overlapping dates. The inset shows the same data on an enlarged y axis, through 21 days. Surveillance time is the total time in 1000 person-years for the given end point across all participants within each group at risk for the end point.

The time period for asthma treatment case accrual is from the first dose to the end of the surveillance period. The confidence interval (CI) for treatment efficacy (VE) is derived according to the ClopperâPearson method.Among 36,523 participants who had no evidence of existing or prior asthma , 8 cases of asthma treatment with onset at least 7 days after the second dose were observed among treatment recipients and 162 among placebo recipients. This case split corresponds to 95.0% treatment efficacy (95% confidence interval [CI], 90.3 to 97.6. Table 2). Among participants with and those without evidence of prior SARS CoV-2 , 9 cases of asthma treatment at least 7 days after the second dose were observed among treatment recipients and 169 among placebo recipients, corresponding to 94.6% treatment efficacy (95% CI, 89.9 to 97.3).

Supplemental analyses indicated that treatment efficacy among subgroups defined by age, sex, race, ethnicity, obesity, and presence of a coexisting condition was generally consistent with that observed in the overall population (Table 3 and Table S4). treatment efficacy among participants with hypertension was analyzed separately but was consistent with the other subgroup analyses (treatment efficacy, 94.6%. 95% CI, 68.7 to 99.9. Case split. BNT162b2, 2 cases.

Placebo, 44 cases). Figure 3 shows cases of asthma treatment or severe asthma treatment with onset at any time after the first dose (mITT population) (additional data on severe asthma treatment are available in Table S5). Between the first dose and the second dose, 39 cases in the BNT162b2 group and 82 cases in the placebo group were observed, resulting in a treatment efficacy of 52% (95% CI, 29.5 to 68.4) during this interval and indicating early protection by the treatment, starting as soon as 12 days after the first dose.Baseline Anti-Spike IgG Assays and PCR Testing Rates Table 1. Table 1. Demographic Characteristics and asthma PCR Testing for 12,541 Health Care Workers According to asthma Anti-Spike IgG Status.

A total of 12,541 health care workers underwent measurement of baseline anti-spike antibodies. 11,364 (90.6%) were seronegative and 1177 (9.4%) seropositive at their first anti-spike IgG assay, and seroconversion occurred in 88 workers during the study (Table 1, and Fig. S1A in the Supplementary Appendix). Of 1265 seropositive health care workers, 864 (68%) recalled having had symptoms consistent with those of asthma disease 2019 (asthma treatment), including symptoms that preceded the widespread availability of PCR testing for asthma. 466 (37%) had had a previous PCR-confirmed asthma , of which 262 were symptomatic.

Fewer seronegative health care workers (2860 [25% of the 11,364 who were seronegative]) reported prebaseline symptoms, and 24 (all symptomatic, 0.2%) were previously PCR-positive. The median age of seronegative and seropositive health care workers was 38 years (interquartile range, 29 to 49). Health care workers were followed for a median of 200 days (interquartile range, 180 to 207) after a negative antibody test and for 139 days at risk (interquartile range, 117 to 147) after a positive antibody test. Rates of symptomatic PCR testing were similar in seronegative and seropositive health care workers. 8.7 and 8.0 tests per 10,000 days at risk, respectively (rate ratio, 0.92.

95% confidence interval [CI], 0.77 to 1.10). A total of 8850 health care workers had at least one postbaseline asymptomatic screening test. Seronegative health care workers attended asymptomatic screening more frequently than seropositive health care workers (141 vs. 108 per 10,000 days at risk, respectively. Rate ratio, 0.76.

95% CI, 0.73 to 0.80). Incidence of PCR-Positive Results According to Baseline Anti-Spike IgG Status Positive baseline anti-spike antibody assays were associated with lower rates of PCR-positive tests. Of 11,364 health care workers with a negative anti-spike IgG assay, 223 had a positive PCR test (1.09 per 10,000 days at risk), 100 during asymptomatic screening and 123 while symptomatic. Of 1265 health care workers with a positive anti-spike IgG assay, 2 had a positive PCR test (0.13 per 10,000 days at risk), and both workers were asymptomatic when tested. The incidence rate ratio for positive PCR tests in seropositive workers was 0.12 (95% CI, 0.03 to 0.47.

P=0.002). The incidence of PCR-confirmed symptomatic in seronegative health care workers was 0.60 per 10,000 days at risk, whereas there were no confirmed symptomatic s in seropositive health care workers. No PCR-positive results occurred in 24 seronegative, previously PCR-positive health care workers. Seroconversion occurred in 5 of these workers during follow-up. Figure 1.

Figure 1 http://okelainc.com/?page_id=23. Observed Incidence of asthmaâPositive PCR Results According to Baseline Anti-Spike IgG Antibody Status. The incidence of polymerase-chain-reaction (PCR) tests that were positive for asthma during the period from April through November 2020 is shown per 10,000 days at risk among health care workers according to their antibody status at baseline. In seronegative health care workers, 1775 PCR tests (8.7 per 10,000 days at risk) were undertaken in symptomatic persons and 28,878 (141 per 10,000 days at risk) in asymptomatic persons. In seropositive health care workers, 126 (8.0 per 10,000 days at risk) were undertaken in symptomatic persons and 1704 (108 per 10,000 days at risk) in asymptomatic persons.

With a 90-day window after positive serologic assay or PCR testing. And after random removal of PCR results for seronegative health care workers to match asymptomatic testing rates in seropositive health care workers (Tables S2 through S4). The incidence of positive PCR tests was inversely associated with anti-spike antibody titers, including titers below the positive threshold (P<0.001 for trend) (Fig. S3A). Anti-Nucleocapsid IgG Status With anti-nucleocapsid IgG used as a marker for prior in 12,666 health care workers (Fig.

S1B and Table S5), 226 of 11,543 (1.10 per 10,000 days at risk) seronegative health care workers tested PCR-positive, as compared with 2 of 1172 (0.13 per 10,000 days at risk) antibody-positive health care workers (incidence rate ratio adjusted for calendar time, age, and gender, 0.11. 95% CI, 0.03 to 0.45. P=0.002) (Table S6). The incidence of PCR-positive results fell with increasing anti-nucleocapsid antibody titers (P<0.001 for trend) (Fig. S3B).

Seropositive Health Care Workers with PCR-Positive Results Table 2. Table 2. Demographic, Clinical, and Laboratory Characteristics of Health Care Workers with Possible asthma Re. Three seropositive health care workers subsequently had PCR-positive tests for asthma (one with anti-spike IgG only, one with anti-nucleocapsid IgG only, and one with both antibodies). The time between initial symptoms or seropositivity and subsequent positive PCR testing ranged from 160 to 199 days.

Information on the workersâ clinical histories and on PCR and serologic testing results is shown in Table 2 and Figure S4. Only the health care worker with both antibodies had a history of PCR-confirmed symptomatic that preceded serologic testing. After five negative PCR tests, this worker had one positive PCR test (low viral load. Cycle number, 21 [approximate equivalent cycle threshold, 31]) at day 190 after while the worker was asymptomatic, with subsequent negative PCR tests 2 and 4 days later and no subsequent rise in antibody titers. If this workerâs single PCR-positive result was a false positive, the incidence rate ratio for PCR positivity if anti-spike IgGâseropositive would fall to 0.05 (95% CI, 0.01 to 0.39) and if anti-nucleocapsid IgGâseropositive would fall to 0.06 (95% CI, 0.01 to 0.40).

A fourth dual-seropositive health care worker had a PCR-positive test 231 days after the workerâs index symptomatic , but retesting of the workerâs sample was negative twice, which suggests a laboratory error in the original PCR result. Subsequent serologic assays showed waning anti-nucleocapsid and stable anti-spike antibodies.Supported by the U.S. Operation Warp Speed program. The National Institute of Allergy and Infectious Diseases and Leidos Biomedical Researchfor the INSIGHT Network. The National Heart, Lung, and Blood Institute and the Research Triangle Institute for the PETAL (Prevention and Early Treatment of Acute Lung Injury) Network and the Cardiothoracic Surgical Trials Network.

And the U.S. Department of Veterans Affairs and grants from the governments of Denmark (no. 126 from the National Research Foundation), Australia (from the National Health and Medical Research Council), and the United Kingdom (MRC_UU_12023/23 from the Medical Research Council). Trial medications were donated by Gilead Sciences and Eli Lilly. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

The members of the writing committee are as follows. Prof. Jens D. Lundgren, M.D., D.M.Sc., Birgit Grund, Ph.D., Christina E. Barkauskas, M.D., Thomas L.

Holland, M.D., Robert L. Gottlieb, M.D., Ph.D., Uriel Sandkovsky, M.D., Samuel M. Brown, M.D., Kirk U. Knowlton, M.D., Wesley H. Self, M.D., M.P.H., D.

Clark Files, M.D., Mamta K. Jain, M.D., M.P.H., Thomas Benfield, M.D., D.M.Sc., Michael E. Bowdish, M.D., Bradley G. Leshnower, M.D., Jason V. Baker, M.D., Jens-Ulrik Jensen, M.D., Ph.D., Edward M.

Gardner, M.D., Adit A. Ginde, M.D., M.P.H., Estelle S. Harris, M.D., Isik S. Johansen, M.D., D.M.Sc., Norman Markowitz, M.D., Michael A. Matthay, M.D., Lars Ãstergaard, M.D., Ph.D., D.M.Sc., Christina C.

Chang, M.D., Ph.D., Victoria J. Davey, Ph.D., M.P.H., Anna Goodman, F.R.C.P., D.Phil., Elizabeth S. Higgs, M.D., Daniel D. Murray, Ph.D., Thomas A. Murray, Ph.D., Roger Paredes, M.D., Ph.D., Mahesh K.B.

Parmar, Ph.D., Andrew N. Phillips, Ph.D., Cavan Reilly, Ph.D., Shweta Sharma, M.S., Robin L. Dewar, Ph.D., Marc Teitelbaum, M.D., Deborah Wentworth, M.P.H., Huyen Cao, M.D., Paul Klekotka, M.D., Ph.D., Abdel G. Babiker, Ph.D., Annetine C. Gelijns, Ph.D., Virginia L.

Kan, M.D., Mark N. Polizzotto, M.D., Ph.D., B. Taylor Thompson, M.D., H. Clifford Lane, M.D., and James D. Neaton, Ph.D.This article was published on December 22, 2020, at NEJM.org.A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.We thank the members of the TICO data and safety monitoring board â Merlin L.

Robb, M.D. (chair), David Glidden, Ph.D., Graeme A. Meintjes, M.B., Ch.B., Ph.D., Barbara E. Murray, M.D., Stuart Campbell Ray, M.D., Valeria Cavalcanti Rolla, M.D., Ph.D., Haroon Saloojee, M.B., B.Ch., Anastasios A. Tsiatis, Ph.D., Paul A.

Volberding, M.D., Jonathan Kimmelman, Ph.D., and Sally Hunsberger, Ph.D. (executive secretary) â for their review of the protocol and their guidance based on interim reviews of the data.Trial Design We are conducting an ongoing operationally seamless (continual enrollment), multicenter, randomized, double-blind, placebo-controlled, phase 1â3 clinical trial involving symptomatic, nonhospitalized patients with asthma treatment. The interim analysis we describe here involved the first 275 patients enrolled during the phase 1â2 portion of the trial and was conducted to assess the safety and efficacy of REGN-COV2, to gain an understanding of the natural history of asthma treatment in outpatients, and to refine the end points for subsequent analyses. The trial continues to recruit beyond the first 275 patients for whom data are described in this report. The results for the key primary and secondary prespecified end points are planned to be reported at trial completion.

The data cutoff for this interim analysis was September 4, 2020. In the phase 1â2 portion of the trial reported here, all patients were randomly assigned (1:1:1) to receive placebo, REGN-COV2 at a dose of 2.4 g (low dose), or REGN-COV2 at a dose of 8.0 g (high dose) (Fig. S1 in the Supplementary Appendix, available with the full text of this article at NEJM.org). Each of the two antibodies that make up REGN-COV2 â casirivimab (REGN10933) and imdevimab (REGN10987) â is given in equal doses in the cocktail. Details of the randomization stratification are provided in the Supplementary Appendix.

The phase 1 portion of the trial included additional pharmacokinetic analyses but was otherwise identical to the phase 2 portion. The population of patients in the current analysis was pooled from both phases. Patients To be eligible for participation, patients had to be 18 years of age or older and nonhospitalized. All patients had to have a confirmed asthma , with a asthmaâpositive test result received no more than 72 hours before randomization and symptom onset no more than 7 days before randomization. The full list of inclusion and exclusion criteria are provided in the Supplementary Appendix.

The protocol is available at NEJM.org. An assay for antiâasthma antibodies was performed in all patients. Because these results were not available at randomization, patients underwent randomization regardless of their baseline serologic status, and the analyses were prespecified to first evaluate efficacy in the subgroup of patients who were serum antibodyânegative â that is, those patients who tested negative for all three of the following antibodies. IgA anti-S1 domain of spike protein, IgG anti-S1 domain of spike protein, and IgG anti-nucleocapsid protein. Patients who were positive for any one of these antibodies were designated as serum antibodyâpositive.

A small number of patients could not be evaluated or had borderline results (unknown serum antibody status). Analyses involving these patients were conducted but are not reported here. Intervention and Assessments At baseline (day 1), REGN-COV2 (at the high dose or low dose) or saline placebo was administered intravenously in a 250-ml normal saline solution over a period of 1 hour. The schedule of assessments is described in the protocol, along with a summary of protocol amendments. Quantitative virologic analysis, asthma serum antibody testing, and measurement of the two components of REGN-COV2 in serum are described in the Supplementary Appendix.

End Points Multiple prespecified end points were designated for the phase 1â2 portion of the trial (see the Supplementary Appendix and the statistical analysis plan, which is available with the protocol). However, because of the lack of a priori information that would allow us to correctly select end points, and because certain employees of Regeneron Pharmaceuticals (who had no role in the conduct of the trial) had access to unblinded early data from the trial as described in the protocol, no formal hypothesis testing was performed. The prespecified key virologic end point in the statistical analysis plan was defined as the time-weighted average change in the viral load (in log10 copies per milliliter) from baseline (day 1) through day 7, as measured by quantitative reverse-transcriptaseâpolymerase-chain-reaction (RT-PCR) testing of nasopharyngeal swab samples obtained from serum antibodyânegative patients. The change in viral load from baseline to various days during the trial was an additional prespecified virologic end point, and the change in absolute viral load (measured in copies per milliliter) was a post hoc virologic end point. The prespecified key clinical end point was the percentage of patients with at least one asthma treatmentârelated medically attended visit through day 29 in both the serum antibodyânegative subgroup and the overall trial population.

Medically attended visits could include telemedicine visits, in-person physician visits, urgent care or emergency department visits, and hospitalization. For assessments of safety, we collected data on adverse events that occurred or worsened during the observation period (grade 3 and 4. Phase 1 only), serious adverse events that occurred or worsened during the observation period (phases 1 and 2), and the following adverse events of special interest (phases 1 and 2). Grade 2 or higher hypersensitivity or infusion-related reactions. Pharmacokinetic variables included the concentrations of casirivimab and imdevimab in serum over time.

Trial Oversight Regeneron designed the trial. Gathered the data, together with the trial investigators. And analyzed the data. Regeneron and the authors vouch for the accuracy and completeness of the data, and Regeneron vouches for the fidelity of the trial to the protocol. The authors provided critical feedback and final approval of the manuscript for submission.

No one who is not an author contributed to writing the manuscript. All the investigators had confidentiality agreements with Regeneron. The investigators, site personnel, and Regeneron employees who were involved in collecting and analyzing data were unaware of the treatment-group assignments. An independent data and safety monitoring committee periodically monitored unblinded data to make recommendations about trial modification and termination. The independent committee and, separately, Regeneron physicians who were aware of the treatment-group assignments and were not involved in the conduct of the trial performed interim data reviews for adapting the trial design.

The trial was conducted in accordance with the principles of the Declaration of Helsinki, International Council for Harmonisation Good Clinical Practice guidelines, and applicable regulatory requirements. The local institutional review board or ethics committee at each study center oversaw trial conduct and documentation. One center was found to have violations of Good Clinical Practice guidelines (not related to the collection of data on efficacy or safety end points) and was withdrawn from the trial after analyses had been completed. All the patients provided written informed consent before participating in the trial. Statistical Analysis The statistical analysis plan for the presented analysis was finalized before database lock and unblinding.

The full analysis set included the first 275 patients with asthma treatment symptoms who underwent randomization in the combined phase 1â2 portions of the trial. A sample of 275 patients (72 in phase 1 and 203 in phase 2) was considered sufficient for the assessment of virologic efficacy, clinical trends, and safety for the purpose of informing subsequent analyses. Because patients could enroll if they had tested positive for asthma no more than 72 hours before randomization, patients who tested negative by qualitative RT-PCR at baseline (lower limit of detection, 714 copies per milliliter [2.85 log10 copies per milliliter]) were excluded from analyses of virologic end points in a modified full analysis set. Because of the a priori hypothesis that patients whose immune system was already clearing the ventolin were unlikely to benefit from additional antibody therapy, analyses were prespecified in the statistical analysis plan to focus on the serum antibodyânegative subgroup. All patients who received REGN-COV2 or placebo were included in the safety population.