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

1 1 1 1

What is this study about?

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.

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

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

3 Study duration

The study continues until December 31, 2025

Your participation duration may vary depending on when you join the study

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medical University Of Vienna	Vienna	Austria

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	01.06.2023

Trial locations

Investigated drugs:

Dupilumab

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.

Investigated diseases:

Asthma

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.

Trial ID:

2024-517567-23-00

Protocol code:

DETACT

Trial Phase:

Human Pharmacology (Phase I) – Other

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?