Effect of Dupilumab on Mucociliary Clearance in Asthma Patients
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
This study is testing if the medication dupilumab can help improve breathing by clearing mucus better in people with moderate to severe asthma.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | dupilumab, prednisone |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT04743791 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 with moderate to severe asthma characterized by specific lung function and inflammatory markers.
Not a fit: Patients who are pregnant, nursing, or have a significant smoking history may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance mucociliary clearance and overall respiratory health in patients with moderate to severe asthma.
How similar studies have performed: Other studies have shown promising results with dupilumab in asthma management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Pittsburgh, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.