Tests dupilumab's effect on mucus clearance in people with moderate to severe asthma
Compares dupilumab with placebo on mucus clearance in adults with moderate to severe asthma.
Plain-language title generated from the registry record
Registry title: Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma
Key facts
- Where
- Pittsburgh, United StatesSee the site
- Phase
- Phase 4
Where in United States
- The University of Pittsburgh Asthma Institute at UPMCPittsburgh, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sally E. Wenzel MD
- Trial code
- NCT04743791
- Record updated
- 6 August 2026
- Original description
Single center, randomized, placebo- controlled study to assess change in mucociliary clearance of moderate to severe asthma patients after treatment with dupilumab or placebo.Read full original descriptionShow less
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
Single center, randomized, placebo- controlled study to assess change in mucociliary clearance of moderate to severe asthma patients after treatment with dupilumab or placebo.
Inclusion: 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.
Exclusion: Current or previous use of dupilumab; Current or recent use of anti-IL-5 therapies; Drug or alcohol addiction in the last 5 years; 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; 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.