The Effect of Dupilumab on Lung Inflammation and Related Changes in Airway Volumes Detectable by Functional Respiratory Imaging in Patients With Moderate-severe Asthma

Part of paid clinical trials in Westminster, California.

Sponsor
Sanofi
Study ID
NCT04400318
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    solution for injection subcutaneous
  • Placebo — DRUG
    Solution for injection subcutaneous

Study Details

Primary Objective: • To assess the effect of dupilumab on lung inflammation and related changes in airway volumes detectable by functional respiratory imaging Secondary Objective: * To evaluate the effect of dupilumab at Week 24 on bronchodynamics, hyperinflation, airway resistance, airway wall thickness, ventilation defects and mucus plugging derived from high-resolution computed tomography (HRCT) scans, patient-reported outcomes, FeNO and spirometry. * To evaluate safety of dupilumab

Key Dates

Start date
Jun 20, 2020
Status verified
Sep 2025
Primary completion
Jun 26, 2023
Completion
Aug 21, 2023

Study Design

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

Arms

  • Experimental: Dupilumab
    Participants received a loading dose of dupilumab 600 mg as 2 subcutaneous (SC) injections on Day 1, followed by a single dupilumab 300 mg SC injection Q2W for 24 weeks along with a stable dose of medium to high ICS dose in combination with a second controller medication +/- a third controller.
  • Placebo Comparator: Placebo
    Participants received placebo matched to dupilumab as 2 x 2 mL SC injections on Day 1, followed by a single SC injection Q2W for 24 weeks along with a stable dose of medium to high ICS dose in combination with a second controller medication +/- a third controller.

Primary Outcome Measure

Percentage of Participants Who Achieved Fractional Exhaled Nitric Oxide (FeNO) Less Than (<) 25 Parts Per Billion (Ppb) at Week 24 [ Time Frame: Week 24 ]

Locations (10)

FacilityCityStateZIPSite coordinators
Allianz Research Institute Site Number : 8400020WestminsterCalifornia92683-
University of Kansas School of Medicine Site Number : 8400008Kansas CityKansas66103-
University of Michigan Site Number : 8400002Ann ArborMichigan48109-
The Lung Research Center Site Number : 8400010ChesterfieldMissouri63017-
American Health Research Site Number : 8400005CharlotteNorth Carolina28277-
Velocity Clinical Research, Medford Site Number : 8400014MedfordOregon97504-
Medical University of South Carolina - Pulmonary & Critical Care Clinical Research Program Site Number : 8400009CharlestonSouth Carolina29425-
VitaLink Research-Greenville Site Number : 8400013GreenvilleSouth Carolina29615-
~Spartanburg Medical Research Site Number : 8400004SpartanburgSouth Carolina29303-
VitaLink Research - Spartanburg Site Number : 8400011SpartanburgSouth Carolina29303-

Find similar trials in Westminster, CA

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Allianz Research Institute· Westminster, CAUniversity of Kansas School of Medicine· Kansas City, KSUniversity of Michigan· Ann Arbor, MIThe Lung Research Center· Chesterfield, MOAmerican Health Research· Charlotte, NCVelocity Clinical Research, Medford· Medford, OR

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