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NCT03960580 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis Without the Presence of Nasal Polyps
A Phase 3 study, sponsored by Optinose US.
- Completed
- Registry status
- Phase 3
- Development phase
- 223
- Enrollment target
NCT03960580: Completed Phase 3 study, sponsored by Optinose US.
NCT03960580 is a Phase 3 study that has completed, run by Optinose US. The registered enrollment target is 223 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03960580, a Phase 3 study, has completed, sponsored by Optinose US.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 223 participants
- Enrollment target
Study Summary
This is a 24-week randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of intranasal administration of 186 and 372 μg twice daily (BID) of OPN-375 in subjects with chronic Rhinosinusitis (CRS) without nasal polyps
Primary Outcome
Change from baseline to the end of Week 4 in average total instantaneous AM scores (evaluation of symptom severity immediately preceding the time of scoring) for each symptom: nasal congestion, nasal discharge (anterior and/or posterior), facial pain/pressure sensation. Baseline scores are the averaged total instantaneous AM scores over the last 7 days of the single blind run in period, and the end of Week 4, scores are averaged over the 7 days from the subject diary. Range of scores for each na
Interventions
- DRUG OPN-375
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 223 participants |
| Start Date | 2019-06-06 |
| Est. Completion | 2022-05-04 |
| Phase | Phase 3 |
What the finished NCT03960580 record still lists
NCT03960580 is an interventional study that assigns participants to a tested intervention. The registered 223 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 1 intervention - of which OPN-375 is the first listed.
NCT03960580 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03960580 about?
NCT03960580 is a clinical study titled "Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis Without the Presence of Nasal Polyps". This is a 24-week randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of intranasal administration of 186 and 372 μg twice daily (BID) of OPN-375 in subjects with chronic Rhinosinusitis (CRS) without nasal polyps
What is the current status of trial NCT03960580?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 223 participants. The study started on 2019-06-06. Estimated completion is 2022-05-04.
What interventions are being tested in trial NCT03960580?
The interventions under investigation include: OPN-375 (DRUG).
Who is sponsoring clinical trial NCT03960580?
This trial is sponsored by Optinose US, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03960580's enrollment target sits among peer trials
223 1317th of 2000 higher than 684 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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