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Actively Recruiting

Phase 4
Age: 40Years - 85Years
All Genders
ID07053423

Effect of Dupilumab on Airway Inflammation and Lung Changes in Adults 40 to 85 Years with Chronic Obstructive Pulmonary Disease

Led by Sanofi · Updated on 2026-06-12

218

Participants Needed

68

Research Sites

5 weeks

Total Duration

AI-Summary

What this Trial Is About

This multinational Phase 4 study evaluates the effect of dupilumab compared with placebo on airway inflammation, resistance, and remodeling in people aged 40 to 85 years with Chronic Obstructive Pulmonary Disease COPD. The study focuses on changes in mucus plugging and how these relate to lung function, exacerbations, and quality of life. Participants receive either dupilumab or placebo via subcutaneous injection according to the study protocol. Treatment lasts up to 24 weeks, and the total study duration can be up to 40 weeks. There are two treatment groups in a randomized, double-blind, placebo-controlled, parallel design. During the study, participants attend nine visits for assessments including lung imaging to measure mucus volume and airway wall thickness, lung function tests using forced oscillation technique, and monitoring for adverse events. The main outcome is the change in global lung mucus score from baseline to Week 24. Safety is followed through Week 36, with ongoing evaluation of lung inflammation and resistance.

CONDITIONS

Brief Title

A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.

Research Team

T

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