NCT04203797

A Study to Evaluate the Effect of Dupilumab on Exercise Capacity in Adult Patients With Asthma

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of Dupilumab on Exercise Capacity in Patients With Moderate-to-Severe Asthma

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to demonstrate that dupilumab treatment improves exercise capacity in patients with moderate-to-severe asthma. The secondary objectives of the study are: * To demonstrate that dupilumab treatment increases physical activity of daily living in patients with moderate-to-severe asthma * To demonstrate that dupilumab treatment improves pre- and post-exercise lung function in patients with moderate-to-severe asthma

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	dupilumab	Pre-filled syringe administered by subcutaneous (SC) injections
DRUG	Matching placebo	Pre-filled syringe administered by subcutaneous (SC)

Timeline

• Start date: 2020-07-16
• Primary completion: 2023-07-15
• Completion: 2023-07-15
• First posted: 2019-12-18
• Last updated: 2024-04-18
• Results posted: 2024-04-18

Locations

30 sites across 5 countries: United States, France, Germany, Poland, Spain

Regulatory

• FDA-regulated drug study