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NCT01623323 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating the Safety of Intranasal Administration of 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi-Directional Device in Subjects With Chronic Sinusitis With or Without Nasal Polyps
A Phase 3 study, sponsored by Optinose US.
- Completed
- Registry status
- Phase 3
- Development phase
- 705
- Enrollment target
NCT01623323: Completed Phase 3 study, sponsored by Optinose US.
NCT01623323 is a Phase 3 study that has completed, run by Optinose US. The registered enrollment target is 705 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01623323, a Phase 3 study, has completed, sponsored by Optinose US.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 705 participants
- Enrollment target
Study Summary
This is an open-label, multicenter study designed to assess the safety of intranasal administration of 400 μg of fluticasone propionate twice a day delivered by the OptiNose device in subjects with chronic sinusitis with or without nasal polyps. The study consists of an up-to-7-day pretreatment phase followed a 3-month open-label treatment phase. The duration of each subject's participation is approximately 13 weeks.
Primary Outcome
Adverse Events were collected via spontaneous subject report and through physician examination. The display of adverse events is by subject.
Interventions
- DRUG Fluticasone Propionate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 705 participants |
| Start Date | 2013-09 |
| Est. Completion | 2015-03 |
| Phase | Phase 3 |
What the finished NCT01623323 record still lists
NCT01623323 is an interventional study that assigns participants to a tested intervention. The registered 705 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Fluticasone Propionate is the first listed.
NCT01623323 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01623323 about?
NCT01623323 is a clinical study titled "Study Evaluating the Safety of Intranasal Administration of 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi-Directional Device in Subjects With Chronic Sinusitis With or Without Nasal Polyps". This is an open-label, multicenter study designed to assess the safety of intranasal administration of 400 μg of fluticasone propionate twice a day delivered by the OptiNose device in subjects with chronic sinusitis with or without nasal polyps. The study consists of an up-to-7-day pretreatment phas...
What is the current status of trial NCT01623323?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 705 participants. The study started on 2013-09. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01623323?
The interventions under investigation include: Fluticasone Propionate (DRUG).
Who is sponsoring clinical trial NCT01623323?
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 NCT01623323's enrollment target sits among peer trials
705 505th of 2000 higher than 1,495 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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