RecruitingPhase 4NCT04743791

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


Sponsor

Sally E. Wenzel MD

Enrollment

30 participants

Start Date

Oct 17, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study measures how dupilumab (an injectable biologic used to treat moderate-to-severe asthma) affects the ability of the lungs to clear mucus and debris — a process called mucociliary clearance — in people with Type 2 (allergic/eosinophilic) asthma. **You may be eligible if...** - You are over 18 with moderate-to-severe Type 2 asthma - Your lung function is below 90% of predicted (FEV1 < 90%) - You are on medium-to-high-dose inhaled corticosteroids (500 mcg/day or more of fluticasone equivalent) - You have documented airway reversibility (your breathing improves with a bronchodilator, or you have a positive challenge test) **You may NOT be eligible if...** - Your asthma is mild or not of the Type 2 (eosinophilic/allergic) variety - You are a smoker or have significant COPD - You have a recent lung infection or recent change in asthma medications - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDupilumab

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.

OTHERPlacebo

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).


Locations(1)

The University of Pittsburgh Asthma Institute at UPMC

Pittsburgh, Pennsylvania, United States

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NCT04743791


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