Status:
RECRUITING
Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma
Lead Sponsor:
Sally E. Wenzel MD
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Single center, randomized, placebo- controlled study to assess change in mucociliary clearance of moderate to severe asthma patients after treatment with dupilumab or placebo.
Eligibility Criteria
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
- Pregnant, nursing, or unwilling to test for pregnancy
- Current smoker or \>10 pack year smoking history
- Body Mass Index (BMI)\>37
- Respiratory infection in 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 Chronic Obstructive Pulmonary Disease (COPD)
- History of non-skin cell cancer in the last 5 years
- Drug or alcohol addiction in the last 5 years
- Any other uncontrolled disease
Key Trial Info
Start Date :
October 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04743791
Start Date
October 17 2022
End Date
September 1 2026
Last Update
November 7 2025
Active Locations (1)
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1
The University of Pittsburgh Asthma Institute at UPMC
Pittsburgh, Pennsylvania, United States, 15213