NCT04743791RecruitingPhase 4
Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma
A Randomized, Placebo-controlled, Parallel Group Study Designed to Assess the Change in Mucociliary Clearance After 12 Weeks of Treatment With Dupilumab in Patients With Moderate to Severe Asthma
Source: ClinicalTrials.gov · Last updated 6 Aug 2026
Brief summary (registry, in English)
Single center, randomized, placebo- controlled study to assess change in mucociliary clearance of moderate to severe asthma patients after treatment with dupilumab or placebo.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 3 Feb 2021
- Start date
- 17 Oct 2022
- Primary completion date
- Dec 2027
- Lead sponsor
- Sally E. Wenzel MD
- Diseases
- Asthma
- NCT number
- NCT04743791
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 30
- From 17 Oct 2022 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or previous use of dupilumab
- Current or recent use of anti-IL-5 therapies
- Drug or alcohol addiction in the last 5 years
Other illness
- Respiratory infection in the last 30 days
- Diagnosis of other lung diseases including Chronic Obstructive Pulmonary Disease (COPD)
- History of non-skin cell cancer in the last 5 years
- Any other uncontrolled disease
Other
- Pregnant, nursing, or unwilling to test for pregnancy
- Current smoker or \>10 pack year smoking history
- Body Mass Index (BMI)\>37
- Use of antibiotics or oral prednisone in the last 30 days
- Any other criteria that place the subject at unnecessary risk
Who the study is looking for
- Moderate - Severe Th2 (Type 2) High asthma, as defined by Forced Expiratory Volume in one second (FEV1) \<90% predicted, on medium to high dose inhaled corticosteroids (ICS) with or without a second controller
- Age \> 18
- Inhaled steroid doses of 500micrograms (mcg) per day or more (Fluticasone equivalent)
- Reversibility \>/= 12% at screening or within the past 2 years, or a positive methacholine challenge test within the past 2 years, or a positive methacholine challenge during screening
- FEV1/Forced Vital Capacity (FVC)\<75%
- Blood Eosinophils (EOS) \>300 cells per mm3
- Exhaled Nitric Oxide (FeNO) \>25 parts per billion (ppb)
- Asthma Control Test (ACT) score \<20
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Pittsburgh Asthma Institute at UPMC Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.