Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma
- Registration Number
- NCT04743791
- Lead Sponsor
- Sally E. Wenzel MD
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo 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. Dupilumab 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.
- Primary Outcome Measures
Name Time Method Change in mucociliary clearance (MCC) rate Measured at 12 weeks after the start of treatment MCC is measured using an aerosol-based nuclear imaging technique
- Secondary Outcome Measures
Name Time Method Change in FEV1% predicted Measured from baseline to 12 weeks after start of treatment Assessed using spirometry after bronchodilator administration.
Change in ACT score Measured from baseline to 12 weeks after start of treatment Measured via the Asthma Control Test questionnaire. Scores range from 5 (poor control of asthma) to 25 (complete control of asthma).
Change in sputum eosinophils and T2 gene mean Measured from baseline to 12 weeks after start of treatment Measured via sputum induction to obtain airway cells and fluid from patients.
Change in mucus plugging score by CT Measured from baseline to 12 weeks after start of treatment Radiologists will visually assess the presence or absence of mucus plugging in segmental airways and will provide a mucus plugging score
Whole lung MCC90, AAC90 Measured from baseline to 12 weeks after start of treatment Measured via mucociliary clearance imaging
Peripheral and central lung MCC90, MCC240, AAC90 Measured from baseline to 12 weeks after start of treatment Measured via mucociliary clearance imaging
Trial Locations
- Locations (1)
The University of Pittsburgh Asthma Institute at UPMC
🇺🇸Pittsburgh, Pennsylvania, United States