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Welcome to our June 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:

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



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



LEARN MORE



Does Your Child Have Uncontrolled Hives?

There is a new clinical trial testing a medicine called dupilumab to see if it can safely help children aged ≥ 2 years to <12 years with chronic spontaneous urticaria (CSU). CSU is marked by the appearance of itchy hives.

Sponsored by Sanofi

LEARN MORE




Surveys

Participants Needed for Mild Asthma Survey

Researchers at the University of Michigan are hoping to learn more about mild asthma. The researchers would like to better understand patients’, parents’, and physicians’ experiences with and concerns about mild asthma to direct future areas of research.

Participation will include a Qualtrics survey with demographic questions and questions about the categorization and treatment of mild asthma.

Who may qualify to participate?

  • Patients >18 years old with mild/intermittent asthma
  • Parents of children <18 years old with mild/intermittent asthma

Participation is voluntary and you can stop participating at any time.

Please click below to proceed to the survey.

PATIENT SURVEY



PARENT SURVEY



Student Spotlight

Take a Quick Survey to Help New Inhaler Development

Miles Lanham, freshman at the University of Virginia, saw his friend have an asthma attack during a workout with no way to get his to his quick-relief inhaler in time. After that, Miles set out to develop a quick-relief inhaler smaller than a handheld eraser, with the goal of making carrying a quick-relief inhaler easier, more comfortable, and less Invasive. It can also be worn on the wrist, attached to a phone, or attached to any other preferred item. We invite you to learn more by following the link to view an infographic, take a quick survey, and to follow the development of the Portahaler. Your feedback is key.

TAKE THE SURVEY


Latest Asthma and Allergy News

Asthma

The Impact of Insomnia and Depression on Asthma Control
People with asthma often report having trouble sleeping, especially if their asthma is not well-controlled. But experts have not fully understood how sleep disorders like insomnia affect asthma. It is also not clear how mood disorders like depression impact asthma control.

In this retrospective study, researchers looked at medical records from a large asthma center. They compared asthma patients with insomnia to patients without insomnia, matching them by age, sex, other health conditions, and asthma treatments. They checked for sleep apnea, mood disorders, asthma attacks, and asthma control test (ACT) scores.

The study found the patients with insomnia were more likely to also have sleep apnea (57.3% vs. 18%) and depression or anxiety (68.5% vs. 11.4%) compared to the patients without insomnia. People with insomnia had on average nearly 1 asthma flare per year, while the average for the patients without insomnia was lower (0.59 flares per year).

The authors suggest that there is significant interaction between insomnia, depression, and sleep apnea in people with asthma and are linked to more frequent asthma flares. The study suggests that sleep and mood disorders can negatively affect asthma control.

Promising Results for Rilzabrutinib, a New Medicine Under Investigation for the Treatment of Moderate to Severe Asthma
An early phase study showed that the drug rilzabrutinib can help reduce asthma attacks and improve symptoms in adults with poorly controlled moderate to severe asthma at different doses.

The results showed that high-dose rilzabrutinib reduced the loss of asthma control by 36%, and the low dose reduced it by 25%. Patients also showed major improvement in their asthma symptoms, with noticeable benefits as early as 2 weeks of treatment.

Rilzabrutinib at high and low doses was well-tolerated over 12 weeks. The most common side effect was diarrhea. No serious issues like low blood cell count, bleeding, or heart problems were reported.

Rilzabrutinib is still being studied, and regulatory authorities have not yet confirmed its safety and effectiveness.

GlaxoSmithKline (GSK) Announces Positive Results for the Treatment of Severe Asthma with a New Medicine
GSK announced positive results from a late phase clinical trialthat studied a medicine called depemokimab. The studies were done in adults and teens with severe asthma marked by high levels of eosinophils, a type of white blood cell. There are three other biologics medicines available now that reduce eosinophils in the lungs. But they have to be injected under the skin every 2 or 4 weeks. This new medicine is given every 6 months by injection.

The trials involved participants who were already on standard asthma treatments. They either received depemokimab or a placebo (non-treatment). Both trials showed that over a year, participants who took depemokimab had fewer asthma flares compared to participants who did not take the treatment. Both depemokimab and placebo has similar rates and severity of adverse events.

Depemokimab is still being tested and is not yet approved. It is also being studied for other inflammatory diseases. GSK plans to use these results to seek approval from health authorities.

Chronic Obstructive Pulmonary Disease (COPD)

New Data Show TEZSPIRE Impact on Moderate to Severe COPD
A recent early phase study on chronic obstructive pulmonary disease (COPD) looked at how well TEZSPIRE® (tezepelumab), approved for asthma, works for people with moderate to very severeCOPD. The study looked at people with COPD who had different levels of blood eosinophils. Blood eosinophils are a type of white blood cell which are found more often in people with asthma.

In the studay, TEZSPIRE reduced COPD flare-ups by 17% over a year compared to no treatment, regardless of blood eosinophil count, but was not statistically significant.

But, for patients with an eosinophil count of 150 cells/µL or more, TEZSPIRE reduced flare-ups by 37%, which was a major improvement. People with even higher blood eosinophils counts (300 cells/µL or more), saw a reduction in flare ups of 46%.

Along with the reduction in flares, the TEZSPIRE groups had improved lung function and quality of life. The drug was generally safe. The most common side effects were worsening of the underlying COPD and COVID-19 infections. Otherwise, there were no differences in side effects from previous asthma studies. TEZSPIRE was approved by the Food and Drug Administration (FDA) for asthma in 2021. It  continues to be studied for COPD but is not yet approved.

Study Shows Dupixent Impact on Uncontrolled COPD
A later phase study in adults looked at Dupixent® (dupilumab) as an add-on treatment for uncontrolled COPD despite being on maximum standard treatment. The group on Dupixent were compared to people on the maximum standard of care for COPD and a placebo (non-treatment). The study focused on patients with high levels of eosinophils, a type of white blood cell. Dupixent has been FDA approved for asthma and other allergic diseases like eczema, eosinophilic esophagitis, and chronic nasal and sinus symptoms from nasal polyps.

The results show that after a year Dupixent reduced moderate to severe COPD flare-ups by 34%. Compared to participants who did not take the treatment, participants on Dupixent had improved lung function, better quality of life, and reduced respiratory symptoms.

Safety results were consistent with known side effects of Dupixent. Common side effects included COVID-19, inflammation of the nasal passages, and headaches. Fewer COPD-related adverse events happened with Dupixent compared to placebo.

The results confirmed earlier positive findings from another study that showed major benefits. The use of Dupixent for COPD is still being studied and has not yet been fully approved. Dupixent is currently being reviewed by the FDA and other regulatory bodies worldwide. The FDA’s decision is expected by June 27, 2024.

Medical Review: June 2024 by Jerry Shier, MD

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