Dupilumab for Moderate to Severe Asthma

This study is looking at how Dupilumab, a medication given by injection, affects people with moderate to severe asthma. We want to see if Dupilumab can improve how well your lungs clear mucus (mucociliary clearance, or MCC). You might be able to join if you are over 18, have moderate to severe asthma, and are already taking medium to high doses of inhaled steroids. Some participants will receive Dupilumab, while others will receive a placebo (an inactive substance that looks like the study drug). We will measure changes in MCC after 12 weeks of treatment to see if Dupilumab is effective. The current recruitment status is unclear.

Study design
This is a single-center, randomized, placebo-controlled study involving 30 participants. It compares Dupilumab to a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary measurement for this study is taken 12 weeks after the start of treatment.

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NCT04743791

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

Recruiting
PHASE4Ages 18+InterventionalTreatment
Sally E. Wenzel MD
~30 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:DupilumabPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in mucociliary clearance (MCC) rate
Measured over Measured at 12 weeks after the start of treatment
Asthma
1 sites across 1 states
Pennsylvania1

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
  • Change in mucociliary clearance (MCC) rateMeasured at 12 weeks after the start of treatment

    MCC is measured using an aerosol-based nuclear imaging technique