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

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Asthma

In brief

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

Key facts

Study ID

NCT04743791

Run by

Sally E. Wenzel MD

People needed

30

Starts

2022-10-17

Expected to finish

2028-06-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The University of Pittsburgh Asthma Institute at UPMC — Pittsburgh, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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