NCT04743791 · Sally E. Wenzel MD
Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma
What this study is about
Single center, randomly assigned, placebo- controlled study to assess change in mucociliary clearance of moderate to severe asthma patients after treatment with dupilumab or placebo.
View original scientific description
Single center, randomized, placebo- controlled study to assess change in mucociliary clearance of moderate to severe asthma patients after treatment with dupilumab or placebo.
Interventions
DRUG
Dupilumab
Dupilumab is supplied as a sterile aqueous solution for SC injection at the concentration of 175 mg/mL in glass pre-filled syringe to deliver 200 mg in 1.14mL.
OTHER
Placebo
Sterile placebo for dupilumab will be provided in identically matched glass pre-filled syringe to deliver 200 mg in 1.14mL, which will match dupilumab 200 mg (1.14mL).
Primary outcome measures
Change in mucociliary clearance (MCC) rate
Time frame: Measured at 12 weeks after the start of treatment
MCC is measured using an aerosol-based nuclear imaging technique
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Pittsburgh, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 10, 2025 · Source of record for eligibility and locations