Asthma and Allergy Clinical Trials

Are You Currently Taking Oral Corticosteroids (OCS) for Your Asthma?

Would you like to contribute to important new research? SUNRISE is a clinical study investigating whether a new biologic treatment called tezepelumab may help to reduce or remove the need for OCS in adults with severe asthma. The study is looking for people who:

• Are between 18 and 80 years of age
• Have had an asthma diagnosis for at least 1 year
• Have been taking OCS for asthma for at least 6 months
• Have been using inhaled corticosteroids for at least a year, and a long-acting beta 2-agonist (LABA) for at least 3 months
• Have not been receiving any biologic treatment for asthma for at least 4 months
  
  

Sponsored by AstraZeneca

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Now Accepting Patients for National Asthma Study

Are you a young adult between the ages of 18 and 30, African American or Black, with persistent asthma? Are you looking to get better control of your asthma? A national study is now accepting patients to test various mobile health programs. If you qualify for the study, you will be asked to use a mobile health program for about 10 weeks and complete four 30-minute questionnaires spread out over the course of one year. Everything is remote – you won’t have to come in for any study visits.

You will receive $160 for completing the study and will be given a Garmin physical activity tracker which you can keep after the study has ended.

Learn more about the study and see if you qualify.

If you have any questions, please contact us at: 734-489-1949 or theathenaproject2022@gmail.com

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Latest Asthma and Allergy News

Atopic Dermatitis

Late-breaking Amlitelimab Phase 2b Data Presented at EADV Show Potential Best-in-Class Profile in Atopic Dermatitis
A new study (STREAM-AD) found that a drug called amlitelimab is effective in treating moderate-to-severe atopic dermatitis in adults who don't respond well to topical treatments. This treatment aims to provide relief to people with persistent itch and skin issues. The study showed that amlitelimab led to major improvements in participants’ skin condition. The highest response was seen in people who received amlitelimab 250 mg with a 500 mg loading dose. This dosage reduced symptoms by 61.5% at week 16 and 64.4% at week 24. Other doses also showed positive results. The next phase of the clinical trial program for amlitelimab in atopic dermatitis is set to begin in 2024.

COVID-19

New CDC Data on Long COVID-19
The Centers for Disease Control and Prevention (CDC) recently released two new data briefs on long COVID in U.S. adults and children. The analyses show that about 1.3% of children and 6.9% of adults ever had long COVID. Also, around .5% of children and 3.4% of adults currently have long COVID, identified by new, returning, or ongoing symptoms they did not have before getting COVID-19. Female children and adults were more likely to have long COVID than males. Hispanic children and adults were also more likely to have long COVID than other racial or ethnic groups.

Study Reveals How Young Children’s Immune Systems Tame SARS-CoV-2
New research explains why young children have milder cases of COVID-19 than adults. A study of infants and young kids found their immune response to the virus is different. When kids get infected, they produce strong and long-lasting antibodies that stay high for 300 days or more. In adults, antibodies usually spike for a few weeks and then decline. Adults with COVID-19 also have high levels of proteins in their blood that are linked to more severe cases of COVID-19, while kids don't. Children have these proteins in their noses instead of in their blood, which might help fight the virus at its entry point. These findings are important for future vaccine development, so they can mimic this strong immune response in kids without causing dangerous inflammation.

Eosinophilic Esophagitis (EoE)

Dupixent® (Dupilumab) sBLA for Treatment of Eosinophilic Esophagitis In Children Aged 1 to 11 Accepted for FDA Priority Review
The Food and Drug Administration (FDA) is reviewing Dupixent (dupilumab) as a possible treatment for children aged 1 to 11 with eosinophilic esophagitis (EoE). Dupixent® is already approved for people aged 12 and older with EoE. The news follows a study that showed Dupixent helped children in this age group achieve and retain remission. While some side effects were noted, they were consistent with the drug's known safety profile. The FDA will aim to make a decision by Jan. 31, 2024.

Food Allergy

Aquestive Therapeutics Reaffirms Timeline and Pathway for Anaphylm™ (Epinephrine) Sublingual Film
Aquestive Therapeutics provided an update on their under-the-tongue epinephrine product, called Anaphylm™. In previous studies, Anaphylm was found to be safe and work as effectively as other forms of epinephrine. The company plans to start a clinical trial for the product in late 2023 in hopes of getting treatment approval by the FDA in 2024.

Single and Repeat Dose Clinical Study of neffy® (Epinephrine Nasal Spray) Published in the Journal of Allergy and Clinical Immunology
The results from a study on neffy were recently published in the Journal of Allergy and Clinical Immunology. It is a form of epinephrine that is sprayed into the nose instead of injected. The study found that neffy works as well as or better than other forms of epinephrine in treating severe allergic reactions. It also delivered consistent epinephrine levels similar to injections and provided a stable response to a second dose, unlike traditional injections. The study found neffy to be well-tolerated, with mild side effects like nasal discomfort and headaches. Despite FDA requirements for more studies on neffy®, ARS Pharma aims to launch neffy® in the second half of 2024 if approved.

FDA Draft Guidance Could Result in Safer Food Options for People with Allergies to Sesame, Other Food Allergens
The FDA has released new guidelines to help food makers follow safety rules regarding allergens. Millions of people in the U.S. have food allergies, which can cause severe reactions called anaphylaxis. Recently, sesame was added as a major allergen, meaning it must be clearly labeled in foods. After the law was passed, some companies started adding sesame to their products on purpose. While doing so follows the law, it limits choices for people with food allergies. The FDA wants companies to prevent allergen cross-contact without adding more allergens. The goal is to make food safe for everyone, especially people with food allergies while providing clear and accurate food labels.

Sublingual Immunotherapy May Result in Desensitization and Remission for Peanut-Allergic Children
New research published in The Journal of Allergy and Clinical Immunology shows that peanut sublingual immunotherapy (SLIT) is safe and effective for young children. It may also result in desensitization and remission for kids with peanut allergy. The study involved 50 kids ages 1 to 4 years. Half of the participants received SLIT for peanut, and half received a placebo. After 36 months, children who were desensitized to peanut stopped treatment and were then tested for remission three months later. Overall, 60% of the treated kids experienced desensitization and 48% experienced remission three months after stopping treatment. No placebo kids outgrew their allergy. While more research is needed, early peanut SLIT appears promising for managing peanut allergies in children.

Health Equity

NIH Launches Community-Led Research Program to Advance Health Equity
The National Institutes of Health (NIH) is supporting a unique community-led research program called ComPASS. This program aims to study and address the social and structural factors in communities that affect people’s health. These include access to safe spaces, healthy food, jobs, transportation, and quality health care. The NIH is providing about $171 million to fund research over five years to 26 community organizations and a coordinating center. These organizations will work with academic institutions to look at the social and economic conditions that lead to health inequalities. The goal of the program is to develop and test strategies to improve these conditions and people’s health by addressing community health disparities.