Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma
Trial Parameters
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 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