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

NCT04203797 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-04-18

Study results available
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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

Interventions

DRUG

dupilumab

Pre-filled syringe administered by subcutaneous (SC) injections

DRUG

Matching placebo

Pre-filled syringe administered by subcutaneous (SC)

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-16
Primary Completion
2023-07-15
Completion
2023-07-15
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04203797 on ClinicalTrials.gov