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

This month, we are highlighting clinical trials, surveys, and news on:

• Adults with asthma
• Epinephrine nasal spray
• Dupilumab for moderate-to-severe asthma and chronic obstructive pulmonary disease (COPD)
• COVID-19 vaccination during pregnancy
• Treatment for chronic spontaneous urticaria (CSU)
  
  

Note: The links below will take you to external websites.

Latest Asthma and Allergy News

Anaphylaxis

News on NDS1C Epinephrine Nasal Spray
Bryn Pharma recently announced new information about their epinephrine nasal spray (NDS1C). The spray is designed to treat severe allergic reactions, also known as anaphylaxis.

The data presented showed the spray is effective in delivering the medicine and is safe for people to use. When given in repeated doses, it also showed no negative effects on safety or effectiveness compared to the single dose.

Data also showed that the spray was absorbed in the body faster than other types of epinephrine injections. This means it could be another option for people who need quick relief from severe allergic reactions if approved.

Asthma

New Research on DUPIXENT® for Adults with Uncontrolled Moderate-to-Severe Asthma
Results from a study on DUPIXENT® (dupilumab) were recently presented at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.

The study looked at how the treatment affects the airways in adults aged 21 to 70 years with moderate-to-severe asthma, or with oral steroid dependent asthma. It found that participants taking DUPIXENT had reduced inflammation in the airways and improved breathing after about 6 months. The medicine also helped reduce mucus buildup in the lungs that can make it hard to breathe.

Using a new imaging technology, researchers saw greater improvements in overall lung function and less mucus in people taking DUPIXENT® compared to people who didn’t take this treatment. The medicine's safety profile was similar to what's already known, with some common side effects like infections and injection site reactions. Overall, the study suggests that DUPIXENT® could be a helpful treatment for adults with moderate-to-severe asthma.

Chronic Obstructive Pulmonary Disease (COPD)

DUPIXENT® Accepted for FDA Priority Review for Treatment of COPD With Type 2 Inflammation
The Food and Drug Administration (FDA) is reviewing a new use for DUPIXENT for treating chronic obstructive pulmonary disease (COPD) in certain adults. The application is based on research showing that in adults who were current or former smokers with uncontrolled COPD and who have a certain type of inflammation, the treatment helped reduce serious COPD flare-ups and improved lung function. The participants maintained the improvements for up to one year.

Safety results were in line with what's known about the medicine, with some common side effects including back pain, COVID-19, diarrhea, headache, and nasopharyngitis.

Priority Review is given to drugs that could make big improvements in treating, diagnosing, and preventing serious conditions. DUPIXENT has previously been approved for use in certain patients with asthma, atopic dermatitis, chronic spontaneous urticaria, chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis. Its use for COPD is still being studied, so its safety and effectiveness haven't been fully confirmed yet by any regulatory authority. The FDA decision is expected by June 27, 2024.

New Clinical Trials for People with COPD
AstraZeneca is starting a new study to see if a medicine called BREZTRI AEROSPHERE® could help people with chronic obstructive pulmonary disease (COPD) who are at risk of serious heart and lung problems including death. They're testing the use of this single inhaler, triple-combination treatment on people with COPD who are more likely to have heart or lung issues, regardless of how often they've had flare-ups in the past. Information from this study will help to provide useful information regarding the overall management of these types of individuals with COPD.

In another study, researchers are also comparing BREZTRI AEROSPHERE® (single inhaler, triple therapy) with another type of treatment (a single inhaler, dual combination) or a placebo inhaler (no treatment) to see which one works better for COPD patients' overall heart and lung health.

COPD affects millions of people around the world. If not treated appropriately, this disease can lead to severe exacerbations of lung and heart problems. Higher risk individuals with this lung disease who are not effectively treated can suffer from severe lung and heart events and even fatalities. These two studies aim to find better treatments to help people with COPD live healthier lives.

COVID-19

COVID-19 Vaccination and Boosting During Pregnancy Protects Infants for 6 Months
A study by the National Institute of Allergy and Infectious Diseases (NIAID) found that pregnant people who get mRNA COVID-19 vaccines can protect their babies from getting sick with COVID-19 for at least six months after birth.

The study looked at 475 babies born to people who were vaccinated during pregnancy. During the study, 271 people got two doses of a COVID-19 vaccine. The remaining 204 got two doses of this vaccine and a COVID-19 booster shot. The results showed that infants of parents who received two COVID-19 vaccine doses during pregnancy had a very good antibody response at birth. In addition, babies born to parents who received two doses of a COVID-19 vaccine with a booster dose during pregnancy had higher levels of antibodies against COVID-19 and greater protections against COVID-19 during their first 6 months of life. Of interest, none of the babies in the study had to go to the hospital because of COVID-19.

This research suggests that getting vaccinated with the COVID-19 vaccine during pregnancy not only protects the parent but also helps protect the baby. Two-dose administration of the vaccine followed by a booster shot during pregnancy provided the best protection for the infants. Finally, this shows that vaccination during pregnancy can help keep newborns safe from COVID-19 until they can get vaccinated themselves.

Chronic Spontaneous Urticaria (CSU)

Results from a Clinical Study on Rilzabrutinib for Chronic Spontaneous Urticaria (CSU)
Positive results from a Phase 2 clinical study called RILECSU show that a medicine called rilzabrutinib can help improve itchiness, hives, and urticaria in adults with CSU.

In the study, different doses of rilzabrutinib were tested. The highest dose showed significant improvement in itchiness, hives severity, and urticaria activity compared to a placebo. Rilzabrutinib was generally well-tolerated, with side effects like diarrhea and nausea reported more often than with the placebo.

Rilzabrutinib is still being studied. Its safety and effectiveness haven't been confirmed by any regulatory authority yet. But these results suggest it could be a helpful treatment for people with moderate-to-severe CSU.

Medical Review: March 2024 by John James, MD; Michael Pistiner, MD, MMSc; and Sarbjit Singh Saini, MD