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NCT04400318 · ClinicalTrials.gov registry record · Phase 4
The Effect of Dupilumab on Lung Inflammation and Related Changes in Airway Volumes Detectable by Functional Respiratory Imaging in Patients With Moderate-severe Asthma
A Phase 4 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 109
- Enrollment target
NCT04400318: Completed Phase 4 study, sponsored by Sanofi.
NCT04400318 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 109 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04400318, a Phase 4 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 109 participants
- Enrollment target
Study Summary
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
Primary Outcome
FeNO was analyzed using a NIOX instrument using a flow rate of 50 milliliters per second (mL/s). This assessment was conducted prior to spirometry and following a fast of greater than or equal to (≥1) hour. The test was performed after a wash out period of bronchodilators.
Interventions
- DRUG Placebo
- DRUG Dupilumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2020-06-20 |
| Est. Completion | 2023-08-21 |
| Phase | Phase 4 |
What the finished NCT04400318 record still lists
NCT04400318 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04400318 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04400318 about?
NCT04400318 is a clinical study titled "The Effect of Dupilumab on Lung Inflammation and Related Changes in Airway Volumes Detectable by Functional Respiratory Imaging in Patients With Moderate-severe Asthma". 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 t...
What is the current status of trial NCT04400318?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 109 participants. The study started on 2020-06-20. Estimated completion is 2023-08-21.
What interventions are being tested in trial NCT04400318?
The interventions under investigation include: Placebo (DRUG), Dupilumab (DRUG).
Who is sponsoring clinical trial NCT04400318?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04400318's enrollment target sits among peer trials
109 737th of 2000 higher than 1,261 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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