A Phase 4, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Effect of Dupilumab on Sleep Disturbance in Patients With Uncontrolled Persistent Asthma

Part of paid clinical trials in Bakersfield, California.

Sponsor
Sanofi
Study ID
NCT04502862
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • SAR231893 — DRUG
    Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous
  • Placebo — DRUG
    Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous

Study Details

Primary Objective: To assess the effect of dupilumab on sleep Secondary Objectives: * To evaluate the effect of dupilumab on additional participant reported sleep outcomes * To evaluate the effect of dupilumab on objective sleep assessment * To evaluate the effect of dupilumab on asthma symptoms * To evaluate the effect of dupilumab on lung function * To evaluate the safety of dupilumab

Key Dates

First listed
Aug 6, 2020
Start date
Aug 10, 2020
Status verified
Dec 2024
Primary completion
Oct 3, 2023
Completion
Nov 10, 2023

Study Design

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

Arms

  • Experimental: Dupilumab
    Participants received a loading dose of 400 mg of dupilumab (2 injections × 200 mg) SC on Day 1, followed by 200 mg Q2W for 12 weeks.
  • Placebo Comparator: Placebo
    Participants received an initial loading dose of matching placebo (2 injections of placebo) SC on Day 1, followed by 1 injection of placebo Q2W for 12 weeks.

Primary Outcome Measure

Change From Baseline to Week 12 in Sleep Disturbance Score Using the Asthma Sleep Disturbance Questionnaire (ASDQ) [ Time Frame: Baseline (Day -6 to Day 1) up to Week 12 ]

Locations (12)

FacilityCityStateZIPSite coordinators
Kern Allergy and Medical Research. Inc. Site Number : 8400003BakersfieldCalifornia93301-
Todd Astor MD Site Number : 8400016Culver CityCalifornia90230-
Southern California Institute for Respiratory Diseases Site Number : 8400009Los AngelesCalifornia90048-
Allergy & Asthma Associates of Santa Clara Valley Site Number : 8400001San JoseCalifornia95117-
Asthma and Allergy Associates, PC Site Number : 8400011Colorado SpringsColorado80907-
Sarasota Clinical Research Site Number : 8400012SarasotaFlorida34239-
Allergy & Asthma Specialists, PSC Site Number : 8400004OwensboroKentucky42301-
The Asthma and Allergy Center Site Number : 8400010BellevueNebraska68123-
OK Clinical Research LLC Site Number : 8400005EdmondOklahoma73034-
Velocity Clinical Research, Medford Site Number : 8400007MedfordOregon97504-
National Allergy and Asthma Research, LLC Site Number : 8400008CharlestonSouth Carolina29407-
TTS Research Site Number : 8400006BoerneTexas78006-

Find similar trials in Bakersfield, CA

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By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Kern Allergy and Medical Research. Inc.· Bakersfield, CATodd Astor MD· Culver City, CASouthern California Institute for Respiratory Diseases· Los Angeles, CAAllergy & Asthma Associates of Santa Clara Valley· San Jose, CAAsthma and Allergy Associates, PC· Colorado Springs, COSarasota Clinical Research· Sarasota, FL

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