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

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

Single center, randomized, placebo- controlled study to assess change in mucociliary clearance of moderate to severe asthma patients after treatment with dupilumab or placebo.

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