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NCT03591068 · ClinicalTrials.gov registry record · Phase 3
Efficacy & Safety of OPN-375 Adults With Bilateral Nasal Polyps Using Nasoendoscopic Video
A Phase 3 study of Nasal Polyposis, sponsored by Optinose US.
- Completed
- Registry status
- Phase 3
- Development phase
- 11
- Enrollment target
- 2
- Study locations
NCT03591068: Completed Phase 3 study of Nasal Polyposis, sponsored by Optinose US.
NCT03591068 is a Phase 3 study of Nasal Polyposis that has completed, run by Optinose US. The registered enrollment target is 11 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03591068, a Phase 3 study of Nasal Polyposis, has completed, sponsored by Optinose US.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 11 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a 24-week, open-label, multi-center study designed to assess the efficacy and safety of OPN-375 186 μg twice a day in subjects with nasal polyps using Nasoendoscopic video. The total planned number of subjects is approximately 10, with each subject receiving OPN-375 186 μg twice a day.
Primary Outcome
: Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. 0: No polyps 1. Mild polyposis: polyps not reaching below the inferior border of the middle turbinate 2. Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate 3. Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate
Conditions Studied
Interventions
- DRUG Fluticasone Propionate
Study Locations (2)
Colorado
- University of Colorado SOM, Department of Otolaryngology - Aurora
Texas
- University of Texas Health Science Center at Houston, McGovern Medical School, Dept. of Otolaryngology, Head and Neck Surgery - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2018-06-07 |
| Est. Completion | 2019-02-22 |
| Phase | Phase 3 |
What the finished NCT03591068 record still lists
NCT03591068 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Nasal Polyposis appearing as the primary indexed condition, and to 1 intervention - of which Fluticasone Propionate is the first listed.
NCT03591068 reports a single indexed study location in Colorado, Texas.
Frequently Asked Questions
What is clinical trial NCT03591068 about?
NCT03591068 is a clinical study titled "Efficacy & Safety of OPN-375 Adults With Bilateral Nasal Polyps Using Nasoendoscopic Video". This is a 24-week, open-label, multi-center study designed to assess the efficacy and safety of OPN-375 186 μg twice a day in subjects with nasal polyps using Nasoendoscopic video. The total planned number of subjects is approximately 10, with each subject receiving OPN-375 186 μg twice a day.
What is the current status of trial NCT03591068?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 11 participants. The study started on 2018-06-07. Estimated completion is 2019-02-22.
What conditions does trial NCT03591068 study?
This clinical trial studies the following conditions: Nasal Polyposis.
What interventions are being tested in trial NCT03591068?
The interventions under investigation include: Fluticasone Propionate (DRUG).
Who is sponsoring clinical trial NCT03591068?
This trial is sponsored by Optinose US, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03591068 being conducted?
This trial has 2 study locations across Colorado, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03591068's enrollment target sits among peer trials
11 1989th of 2000 higher than 12 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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