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

Who is this study for? Patients with moderate to severe asthma
What treatments are being studied? Dupilumab
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Pennsylvania
The University of Pittsburgh Asthma Institute at UPMC
RECRUITING
Pittsburgh
Contact Information
Primary
John Moore
mooreja6@upmc.edu
412-648-6726
Time Frame
Start Date: 2022-10-17
Estimated Completion Date: 2026-09
Participants
Target number of participants: 30
Treatments
Active_comparator: Dupilumab
Two injections of Dupilumab will be administered at Week 0/Visit 3 as a loading dose. Subsequently one injection of Dupilumab will be given every 2 weeks ± 3 days at home by the patient. The doses of investigational product must be separated by ≥11 days to avoid an overdose.
Placebo_comparator: Placebo
Two injections of placebo will be administered at Week 0/Visit 3 as a loading dose. Subsequently one injection of placebo will be given every 2 weeks ± 3 days at home by the patient. The doses must be separated by ≥11 day.
Related Therapeutic Areas
Asthma
Sponsors
Leads: Sally E. Wenzel MD

This content was sourced from clinicaltrials.gov

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