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

• Status: Not yet recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sally E. Wenzel MD

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

• Drug or alcohol addiction in the last 5 years

• Any other uncontrolled disease