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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 is a Phase 3 study that has completed, run by Optinose US. The registered enrollment target is 705 participants.
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.
Interventions
- DRUG Fluticasone Propionate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 705 participants |
| Start Date | 2013-09 |
| Est. Completion | 2015-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01623323
The ClinicalTrials.gov registry entry for NCT01623323 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 705 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Optinose US, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fluticasone Propionate is the first listed.
NCT01623323 reports 0 study locations.
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.
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