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A Study to Evaluate the Effect of Dupilumab on Exercise Capacity in Adult Patients With Asthma | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

NCT04203797•Regeneron Pharmaceuticals

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•A physician diagnosis of asthma
•Pre-bronchodilator FEV1 between 30% and 75% predicted at both the screening and baseline visits
•Bronchodilator reversibility defined as \>200 mL and 12% increase in FEV1 post-administration of a short-acting beta agonist (SABA). A patient may also qualify if there is a documented history of bronchodilator reversibility or positive methacholine challenge test within 12 months prior to the screening visit
•Stable background therapy for at least 3 months with a stable dose ≥4 weeks prior to the baseline visit of a medium-to-high dose ICS (fluticasone propionate ≥250 to 1000 μg twice daily \[BID\] or equivalent) in combination with at least a second controller medication (eg, long-acting beta agonist \[LABA\], long-acting muscarinic antagonist \[LAMA\], leukotriene receptor antagonist \[LTRA\], theophylline, etc.); a third controller is allowed and with the same stabilization requirements
•Blood eosinophil count ≥300 cells/μL for patients not on maintenance OCS at the screening visit
•ACQ-5 score ≥1.5 at the screening and baseline visits

Exclusion Criteria

•Body mass index \>35 kg/m2 at screening
•Current smoking, vaping or tobacco chewing or cessation of any of these within 6 months prior to randomization, or \>10 pack years smoking history
•Patients who require supplemental oxygen at screening
•Clinically significant cardiac disease as described in the protocol
•Uncontrolled hypertension at screening or baseline
•Participation in exercise or physical rehabilitation program within last 6 months prior to screening or planned during the study
•Previous use of dupilumab
•Anti-IgE therapy (eg, omalizumab \[Xolair®\]) within 130 days prior to visit 1 or any other biologic therapy (including anti-IL5, anti-IL-5R, anti-IL4Rα, anti-IL-13 mAb) or systemic immunosuppressant (eg, methotrexate, any anti-tumor necrosis factor mAbs, Janus kinase inhibitors, B- and/or T-cell targeted immunosuppressive therapies) to treat inflammatory disease or autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis) and other diseases, within 3 months or 5 half-lives prior to screening, whichever is longer
•Exposure to another investigative drug (monoclonal antibodies as well as small molecules) within a period prior to screening, of \<3 months or \<5 half-lives (whichever is longer)
•Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
+1 more criteria

Locations (30)

Palos Verdes Medical Group (PVMG); Peninsula Research Associates (PRA)

Rolling Hills Estates, California, United States

UCLA Medical Center - Harbor

Torrance, California, United States

Allianz Research Institute

Westminster, California, United States

University of Iowa Hospitals & Clinics-Roy J. and Lucille A. Carver College of Medicine

Iowa City, Iowa, United States

University Of Kansas Medical Center

Kansas City, Kansas, United States

Infinity Medical Research

North Dartmouth, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

American Health Research

Charlotte, North Carolina, United States

UH Cleveland Medical Center

Cleveland, Ohio, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

July 16, 2020

Primary Completion Date

July 15, 2023

Completion Date

July 15, 2023

Last Updated

April 18, 2024

Enrollment

ACTUAL participants

Conditions

Asthma

Interventions

dupilumab

DRUG

Matching placebo

DRUG

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

NCT02327897

Asthma

View study

RECRUITINGNA

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NCT07486401

Asthma ExacerbationsBiomarkers / Blood+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

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