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NCT04502862 · ClinicalTrials.gov registry record · Phase 4
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
A Phase 4 study of Asthma, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 202
- Enrollment target
- 20
- Study locations
NCT04502862: Completed Phase 4 study of Asthma, sponsored by Sanofi.
NCT04502862 is a Phase 4 study of Asthma that has completed, run by Sanofi. The registered enrollment target is 202 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04502862, a Phase 4 study of Asthma, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 202 participants
- Enrollment target
- 20
- Study locations
Study Summary
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
Primary Outcome
The ASDQ is a participant-reported outcome (PRO) measure designed to assess the impact of asthma on participants' sleep. Participants were instructed to record the severity of the disturbance of their sleep due to asthma as: 0 = slept through the night, no asthma symptoms; 1 = slept well, no night time awakenings because of asthma, but some asthma symptoms in the morning; 2 = woke up once because of asthma (may or may not include early awakening); 3 = woke up several times because of asthma (may
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SAR231893
Study Locations (20)
California
- Kern Allergy and Medical Research. Inc. Site Number : 8400003 - Bakersfield
- Todd Astor MD Site Number : 8400016 - Culver City
- Southern California Institute for Respiratory Diseases Site Number : 8400009 - Los Angeles
- Allergy & Asthma Associates of Santa Clara Valley Site Number : 8400001 - San Jose
Buenos Aires
- Investigational Site Number : 0320003 - CABA
- Investigational Site Number : 0320001 - CABA
Santa Fe Province
- Investigational Site Number : 0320004 - Rosario
- Investigational Site Number : 0320005 - Rosario
Other
- Investigational Site Number : 0320002 - Buenos Aires
- Investigational Site Number : 1240009 - Québec
Ontario
- Investigational Site Number : 1240012 - Ajax
- Investigational Site Number : 1240005 - Toronto
Colorado
- Asthma and Allergy Associates, PC Site Number : 8400011 - Colorado Springs
Florida
- Sarasota Clinical Research Site Number : 8400012 - Sarasota
Kentucky
- Allergy & Asthma Specialists, PSC Site Number : 8400004 - Owensboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2020-08-10 |
| Est. Completion | 2023-11-10 |
| Phase | Phase 4 |
What the finished NCT04502862 record still lists
NCT04502862 is an interventional study that assigns participants to a tested intervention. The registered 202 participants enrollment target is mid-sized for trials with a published cap, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04502862 names 20 study sites across 13 states, led by California, Buenos Aires, Santa Fe Province.
Frequently Asked Questions
What is clinical trial NCT04502862 about?
NCT04502862 is a clinical study titled "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". 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 ...
What is the current status of trial NCT04502862?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 202 participants. The study started on 2020-08-10. Estimated completion is 2023-11-10.
What conditions does trial NCT04502862 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT04502862?
The interventions under investigation include: Placebo (DRUG), SAR231893 (DRUG).
Who is sponsoring clinical trial NCT04502862?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04502862 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Kentucky, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Asthma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04502862's enrollment target sits among peer trials
202 161st of 374 higher than 214 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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