Effect of Dupilumab on Mucociliary Clearance in Asthma Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a single-center, randomized, placebo-controlled study designed to evaluate the impact of dupilumab treatment on mucociliary clearance in patients with moderate to severe asthma. Participants will be assessed for changes in their mucociliary function after receiving either dupilumab or a placebo. The study focuses on individuals with specific asthma characteristics, including high eosinophil counts and poor asthma control. The trial aims to provide insights into how dupilumab may improve respiratory function in this patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• The University of Pittsburgh Asthma Institute at UPMC
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: John Moore
• Email: mooreja6@upmc.edu
• Phone: 412-648-6726

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Inhaled CHF10136 safety and pharmacokinetics in healthy adults and adults with asthma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.