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

Part of paid clinical trials in Rolling Hills Estates, California.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT04203797
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • dupilumab — DRUG
    Pre-filled syringe administered by subcutaneous (SC) injections
  • Matching placebo — DRUG
    Pre-filled syringe administered by subcutaneous (SC)

Study Details

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

Key Dates

Start date
Jul 16, 2020
Status verified
Mar 2024
Primary completion
Jul 15, 2023
Completion
Jul 15, 2023

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: dupilumab
    A loading dose at the start of the treatment followed by once every two weeks (Q2W).
  • Experimental: Matching placebo
    Matching dupilumab

Primary Outcome Measure

Change From Baseline to Week 12 in Constant Work Rate Exercise Endurance Time - CWRET (Constant Work Rate Exercise Test) [ Time Frame: Up to week 12 ]

Locations (13)

FacilityCityStateZIPSite coordinators
Palos Verdes Medical Group (PVMG); Peninsula Research Associates (PRA)Rolling Hills EstatesCalifornia90274-
UCLA Medical Center - HarborTorranceCalifornia90509-
Allianz Research InstituteWestminsterCalifornia92683-
University of Iowa Hospitals & Clinics-Roy J. and Lucille A. Carver College of MedicineIowa CityIowa52242-
University Of Kansas Medical CenterKansas CityKansas66160-
Infinity Medical ResearchNorth DartmouthMassachusetts02747-
University of MichiganAnn ArborMichigan48109-
American Health ResearchCharlotteNorth Carolina28277-
UH Cleveland Medical CenterClevelandOhio44106-
Temple University HospitalPhiladelphiaPennsylvania19140-
Regeneron Study SiteHendersonvilleTennessee37075-
The University of Texas Medical School at HoustonHoustonTexas77030-
Intermountain Medical CenterMurrayUtah84107-

Find similar trials in Rolling Hills Estates, CA

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Palos Verdes Medical Group (PVMG); Peninsula Research Associates (PRA)· Rolling Hills Estates, CAUCLA Medical Center - Harbor· Torrance, CAAllianz Research Institute· Westminster, CAUniversity of Iowa Hospitals & Clinics-Roy J. and Lucille A. Carver College of Medicine· Iowa City, IAUniversity Of Kansas Medical Center· Kansas City, KSInfinity Medical Research· North Dartmouth, MA

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