Actively Recruiting
Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma
Led by Sally E. Wenzel MD · Updated on 2025-11-10
30
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Single center, randomized, placebo- controlled study to assess change in mucociliary clearance of moderate to severe asthma patients after treatment with dupilumab or placebo.
CONDITIONS
Official Title
Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Moderate to severe Th2 high asthma defined by FEV1 less than 90% predicted on medium to high dose inhaled corticosteroids with or without a second controller
- Daily inhaled steroid dose of 500 micrograms or more (fluticasone equivalent)
- Reversibility of 12% or more at screening or in the past 2 years, or positive methacholine challenge test within past 2 years or during screening
- FEV1/Forced Vital Capacity less than 75%
- Blood eosinophils greater than 300 cells per mm3
- Exhaled nitric oxide (FeNO) greater than 25 parts per billion
- Asthma Control Test score less than 20
You will not qualify if you...
- Pregnant, nursing, or unwilling to test for pregnancy
- Current smoker or more than 10 pack years smoking history
- Body mass index over 37
- Respiratory infection within the last 30 days
- Use of antibiotics or oral prednisone in the last 30 days
- Current or previous use of dupilumab
- Current or recent use of anti-IL-5 therapies
- Any other criteria that place the subject at unnecessary risk
- Diagnosis of other lung diseases including COPD
- History of non-skin cell cancer within the last 5 years
- Drug or alcohol addiction within the last 5 years
- Any other uncontrolled disease
AI-Screening
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Trial Site Locations
Total: 1 location
1
The University of Pittsburgh Asthma Institute at UPMC
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
J
John Moore
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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