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
Overview
- Phase
- Phase 4
- Intervention
- Dupilumab
- Conditions
- Asthma
- Sponsor
- Sally E. Wenzel MD
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in mucociliary clearance (MCC) rate
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
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.
Investigators
Sally E. Wenzel MD
Professor
University of Pittsburgh
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Dupilumab
Two injections of Dupilumab will be administered at Week 0/Visit 3 as a loading dose. Subsequently one injection of Dupilumab will be given every 2 weeks ± 3 days at home by the patient. The doses of investigational product must be separated by ≥11 days to avoid an overdose.
Intervention: Dupilumab
Placebo
Two injections of placebo will be administered at Week 0/Visit 3 as a loading dose. Subsequently one injection of placebo will be given every 2 weeks ± 3 days at home by the patient. The doses must be separated by ≥11 day.
Intervention: Placebo
Outcomes
Primary Outcomes
Change in mucociliary clearance (MCC) rate
Time Frame: Measured at 12 weeks after the start of treatment
MCC is measured using an aerosol-based nuclear imaging technique
Secondary Outcomes
- Change in FEV1% predicted(Measured from baseline to 12 weeks after start of treatment)
- Change in ACT score(Measured from baseline to 12 weeks after start of treatment)
- Whole lung MCC90, AAC90(Measured from baseline to 12 weeks after start of treatment)
- Change in sputum eosinophils and T2 gene mean(Measured from baseline to 12 weeks after start of treatment)
- Change in mucus plugging score by CT(Measured from baseline to 12 weeks after start of treatment)
- Peripheral and central lung MCC90, MCC240, AAC90(Measured from baseline to 12 weeks after start of treatment)