NCT04039113

Tezepelumab COPD Exacerbation Study

A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) (COURSE)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 337 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Detailed description

This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving triple inhaled maintenance therapy, and having had 2 or more documented COPD exacerbations in the 12 months prior to Visit 1. Approximately, 338 subjects will be randomized globally. Subjects will be stratified by region and prior number of exacerbations (2 vs. 3 or more). Subjects will receive tezepelumab, or placebo, administered via subcutaneous injection at the study site, over a 52 week treatment period. The study also includes a post-treatment follow-up period of 12 weeks.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
BIOLOGICAL	Tezepelumab	Tezepelumab subcutaneous injection
OTHER	Placebo	Placebo subcutaneous injection

Timeline

• Start date: 2019-07-30
• Primary completion: 2023-11-10
• Completion: 2024-01-31
• First posted: 2019-07-31
• Last updated: 2025-02-18
• Results posted: 2025-02-18

Locations

91 sites across 10 countries: United States, Canada, Denmark, France, Germany, Israel, Netherlands, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study