Welcome to our June research update! Getting involved with research is an important way to impact asthma and allergy treatments, education, and awareness.

The Asthma and Allergy Foundation of America (AAFA) works with doctors, researchers, patients, caregivers, public health, and government agencies to conduct and support research that is important to people affected by asthma and allergies.

Here are current research opportunities you can get involved in as a person with asthma or allergies (or as a caregiver for someone with asthma and allergies):

Latest Asthma and Allergy Research News

New Report on the Current State of Health Care for Eosinophilic Esophagitis
AAFA and the American Partnership for Eosinophilic Disorders (APFED) published a new report called “Life with EoE: The Patient Experience and Opportunities to Improve Care in the U.S.”

The report highlights the current state of EoE care in the United States. This includes challenges and barriers to timely diagnosis, quality medical care, effective treatments, and access to resources for EoE. These challenges also present opportunities to address the unmet needs and improve future care for people living with EoE in the United States.

This report is the result of a research study on the needs of people with EoE and their caregivers. We collected data through social listening of peer-to-peer discussions, one-on-one interviews with people with EoE and caregivers, a survey of people with EoE and caregivers, and a survey of health care providers who treat people with EoE.

Race-Based Disparities in Asthma: A Post-Pandemic Snapshot
A new analysis from AAFA and Komodo Health highlights race-based disparities in asthma outcomes following the COVID-19 pandemic. The COVID-19 pandemic brought a surprising period of relief for many people with asthma. Asthma attacks declined and some patients reported breathing more easily. But an earlier analysis of asthma data during the COVID-19 pandemic found while overall numbers of emergency department visits went down, race-based gaps grew.

This analysis sought to understand how race-based disparities in asthma have changed since the COVID-19 pandemic. It found that more severe disease and emergency department use in cities where a higher number of residents are Black. The analysis shows that data can help us better understand health disparities and improve equity in asthma health and care.

Lessons Learned Around COVID-19 and Asthma
A new review highlights lessons learned regarding asthma and the COVID-19 pandemic. The review confirms asthma is not considered a risk factor for getting COVID-19 or dying from COVID-19. But people with more severe asthma that is not well-controlled are at an increased risk for COVID-19 infection.

The review also stresses that asthma does not protect against COVID-19. People with asthma should be strongly encouraged to get COVID-19 vaccines, practice good hygiene, wear a mask, and practice physical distancing depending on their local infection risk. The review highlights how the pandemic revealed much about the health care behavior of people with asthma. It showed us different and valuable ways to manage asthma, which can inspire better management using digital technologies.

Asthma Patients Undergoing Regular High-intensity Exercise May Be Able to Reduce Daily Inhaled Corticosteroid Dosage
A new study suggests that supervised high-intensity interval training (HIIT) can help reduce the need for asthma medicine. The study compared two groups of adults with persistent asthma. The first group did supervised HIIT three times a week for six months. The other group followed their usual lifestyle. Every two months, participants’ medicine doses were adjusted based on how well their symptoms were controlled.

After six months, the exercise group reduced their doses more than the control group. The exercise group also reported improved symptoms and a better quality of life compared to the control group. The positive effects of exercise lasted even after 12 months without impacting asthma control. The study reinforces that regular aerobic exercise is an important part of managing asthma and may reduce the need for medicine.

Under-the-Tongue Epinephrine Film, Anaphylm™, Showed Positive Results in Recent Clinical Tests

Aquestive Therapeutics, a pharmaceutical company, conducted pilot studies to test their new product called Anaphylm. Anaphylm is an under-the-tongue epinephrine being developed to treat severe allergic reactions. The pilot studies focused on the effectiveness and safety of Anaphylm.

The results showed that Anaphylm was able to deliver epinephrine within 10 minutes of being given. These results are positive as severe allergic reactions, called anaphylaxis, need to be treated quickly. The studies also compared Anaphylm with auto-injector forms of epinephrine. The data showed that Anaphylm provided higher epinephrine levels during the first 10 minutes compared to the other forms. The studies found no major adverse events reported among the participants who received Anaphylm. This suggests the treatment is safe and well-tolerated by patients. Aquestive Therapeutics plans to submit a protocol for another trial to the Food and Drug Administration (FDA) later this year. This trial will provide further information on the effectiveness and safety of Anaphylm.

FDA Approves AYVAKIT® (Avapritinib) as the First and Only Treatment for Indolent Systemic Mastocytosis
The FDA has approved a medicine called AYVAKIT® for the treatment of adults with a rare condition called indolent systemic mastocytosis (ISM). This is the first and only approved medicine designed to treat this disease.

AYVAKIT was developed to target the main cause of the ISM and was previously approved for the treatment of advanced cases in June 2021. The approval of AYVAKIT is based on a large study called the PIONEER trial, which showed major improvements in symptoms and measures of the disease compared to a placebo. The medicine was well-tolerated with mostly mild-to-moderate side effects. The approval marks a major step in the treatment of ISM and provides hope for the people affected by this condition.

FDA Advisory Committee Unanimously Recommends Nirsevimab as the First Vaccine Against RSV for All Infants
The FDA Antimicrobial Drugs Advisory Committee (AMDAC) has voted in favor of a new vaccine to help prevent respiratory syncytial virus (RSV) in newborns and infants. The vaccine is called nirsevimab. The committee unanimously agreed that nirsevimab is effective in preventing RSV lower respiratory tract disease (LRTD) in newborns and infants during their first RSV season and for children up to 24 months old who are still at risk in their second RSV season.

If approved, nirsevimab would be the first vaccine designed to protect all infants during their first RSV season, regardless of their health condition or preterm status. The FDA accepted the application for nirsevimab in 2022 and is expediting its review. The FDA will consider the AMDAC’S recommendation during its review of the application for nirsevimab. If approved by the third quarter of 2023, nirsevimab will be available in the U.S. before the 2023-2024 RSV season.

FDA Announces Additional Steps to Modernize Clinical Trials
The FDA has released draft guidance with updated recommendations for good clinical practices (GCPs) in clinical trials. The goal is to modernize the design and conduct of trials, making them more efficient without compromising the safety of participants or the accuracy of the data collected.

GCPs are important for participant safety and data integrity. But the current trial system has been seen as costly, inefficient, and lacking collaboration and innovation. The new draft recommendations aim to streamline trials, making them more flexible and efficient.

The FDA hopes that the finalized recommendations will encourage thoughtful and safe approaches to clinical trials while embracing innovative technologies and trial designs, such as the use of digital health technologies like wearable sensors to facilitate data collection and patient recruitment. The draft guidance will be open for public comment for 60 days. They will consider feedback before finalizing the guideline.