NCT04400318

The Effect of Dupilumab on Lung Inflammation and Related Changes in Airway Volumes Detectable by Functional Respiratory Imaging in Patients With Moderate-severe Asthma

Randomized, Double Blind, Placebo Controlled Study to Evaluate the Effect of Dupilumab on Airway Inflammation Through Assessments of Lung Function, Mucus Plugging and Other Lung Imaging Parameters in Patients With Asthma

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: • To assess the effect of dupilumab on lung inflammation and related changes in airway volumes detectable by functional respiratory imaging Secondary Objective: * To evaluate the effect of dupilumab at Week 24 on bronchodynamics, hyperinflation, airway resistance, airway wall thickness, ventilation defects and mucus plugging derived from high-resolution computed tomography (HRCT) scans, patient-reported outcomes, FeNO and spirometry. * To evaluate safety of dupilumab

Detailed description

The study duration for each participant was a total of minimum 29 weeks and up to 41 weeks. This included 4 weeks +/-1 week screening period, 24 weeks of treatment period and a follow-up period up to 12 weeks or until the participants switched to commercialized dupilumab (or other biologic products), whatever came first.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Dupilumab	solution for injection subcutaneous
DRUG	Placebo	Solution for injection subcutaneous

Timeline

• Start date: 2020-06-20
• Primary completion: 2023-06-26
• Completion: 2023-08-21
• First posted: 2020-05-22
• Last updated: 2025-09-09
• Results posted: 2024-07-10

Locations

65 sites across 13 countries: United States, Bulgaria, Denmark, France, Italy, Portugal, Romania, Saudi Arabia, Spain, Sweden, Taiwan, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study