Overview
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
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
- Drug or alcohol addiction in the last 5 years
- Any other uncontrolled disease