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Study of Dupilumab's Effect on Airway Mucus in Adults with Severe Asthma

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with severe asthma, a condition where the airways become inflamed and narrow, making breathing difficult. The research examines how a medication called Dupilumab, given as an injection under the skin, affects mucus buildup in the airways of people with severe asthma. Mucus plugs are collections of thick secretions that can block the breathing passages and make asthma symptoms worse.

The medication Dupilumab (also known as REGN668) is already approved for treating severe asthma and will be administered through a pre-filled syringe containing 300 mg of the medicine. The purpose of this research is to understand how this treatment affects the accumulation of mucus in the airways of people with severe asthma.

The study will last approximately 22 months, during which participants will receive subcutaneous injections (shots given under the skin) of Dupilumab. Throughout the study, doctors will monitor how the medication affects the mucus plugs in the airways and observe changes in breathing patterns and inflammation levels in participants with severe asthma.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment
You will receive Dupixent (dupilumab) as a solution for injection under the skin (subcutaneous injection)
The medication comes in pre-filled syringes containing 300 mg of the active substance
Step 2
Treatment monitoring
Your airways will be monitored to assess how the medication affects mucus formation
The study will evaluate the effectiveness of Dupixent in treating severe asthma
Medical staff will track changes in your breathing and airway condition throughout the treatment
Step 3
Study duration
The study continues until December 31, 2025
Your participation duration may vary depending on when you join the study
Step 4
Treatment requirements
Regular measurements of specific substances in your blood will be taken to monitor your response to treatment
If you have previously used other similar medications, a waiting period of at least one month must have passed before starting this treatment

Who can join the trial?

8 criteria

Must be 18 years of age or older
Must have a confirmed medical diagnosis of asthma
Must meet specific criteria for severe asthma treatment with Dupilumab, including:
- FeNO (a measure of inflammation in breath) greater than 25 parts per billion
- Either two blood tests showing eosinophils (type of white blood cells) count of 250 per microliter or higher, OR one such measurement while reducing oral corticosteroid medication
- One measurement showing either sputum eosinophils (in mucus) of 2% or higher, or BAL eosinophils (in lung fluid) of 1% or higher
- If previously treated with monoclonal antibodies (specialized medications) for asthma or nasal polyps, must have stopped treatment for at least:
  - Two half-lives of the previous medication, or
  - One month, whichever is longer
  - Can be either male or female

Who cannot join the trial?

14 criteria

History of anaphylaxis (severe, life-threatening allergic reaction) to any biological therapy or monoclonal antibody
Participation in another clinical trial within the past 30 days
Current active parasitic infection (infections caused by parasites living in the body)
Significant respiratory tract infection within 4 weeks before screening
Current diagnosis of active tuberculosis (TB)
History of cancer within the past 5 years (except successfully treated non-melanoma skin cancer)
Significant liver disease or abnormal liver function tests
Pregnant women or women planning pregnancy during the study period
Breastfeeding women
Uncontrolled medical conditions that could interfere with the study, such as heart disease or diabetes
Regular use of systemic corticosteroids (oral or injectable steroids) for conditions other than asthma
Known immunodeficiency disorder (conditions that weaken the immune system)
History of alcohol or drug abuse within the past year
Mental health conditions that could affect ability to comply with study requirements

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Verified sites

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Verified
Medical University Of Vienna
Vienna, Austria

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Investigated drugs

Dupilumab is a medication used to treat severe asthma. It works by targeting specific proteins in the body that cause inflammation in the airways. This medication helps reduce inflammation and mucus production in the airways, making it easier for patients with severe asthma to breathe. It is administered as an injection under the skin and is particularly beneficial for patients whose asthma is not well controlled with standard asthma treatments.

Dupilumab

What is already known about the treatment

Dupilumab - A biologic medication administered through subcutaneous injection that represents a significant advancement in the treatment of severe asthma. It works by blocking two specific proteins (interleukin-4 and interleukin-13) that play key roles in type 2 inflammation, which is a major component of asthma pathology. The drug belongs to the class of monoclonal antibodies and has been proven effective in reducing asthma exacerbations, improving lung function, and decreasing the need for oral corticosteroids in patients with severe asthma, particularly those with elevated levels of specific inflammatory markers. This medication is particularly notable for its ability to target mucus plugging in airways, which is a significant problem for severe asthma patients.

Investigated diseases

Severe Asthma - A chronic respiratory condition characterized by significant inflammation and narrowing of the airways. The condition involves recurrent episodes of breathing difficulties, wheezing, chest tightness, and coughing, particularly at night or early morning. In severe asthma, these symptoms occur more frequently and intensely than in mild or moderate asthma, with airways becoming filled with excess mucus and experiencing muscle tightening. The condition often leads to reduced lung function and affects daily activities. Severe asthma can be persistent despite using standard asthma medications.