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NCT01622569 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating the Efficacy and Safety of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi Directional Device in Subjects With Bilateral Nasal Polyposis Followed by an 8-Week Open-Label Extension Phase to Assess Safety
A Phase 3 study, sponsored by Optinose US.
- Completed
- Registry status
- Phase 3
- Development phase
- 323
- Enrollment target
NCT01622569 is a Phase 3 study that has completed, run by Optinose US. The registered enrollment target is 323 participants.
The verdict
NCT01622569, a Phase 3 study, has completed, sponsored by Optinose US.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 323 participants
- Enrollment target
Study Summary
The primary objective of this study is to compare the efficacy of intranasal administration of 100, 200, and 400 μg of fluticasone propionate twice a day delivered by the OptiNose device with placebo in subjects with bilateral nasal polyposis. Two co-primary endpoints will be used in the study: reduction of nasal congestion/obstruction symptoms at the end of Week 4 of the double-blind treatment phase measured by the 7 day average instantaneous AM diary symptom scores, and reduction in total polyp grade (sum of scores from both nasal cavities) over the 16 weeks of the double-blind treatment phase as determined by the Lildholdt scale score measured by nasoendoscopy.
Interventions
- DRUG Fluticasone Propionate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 323 participants |
| Start Date | 2013-11-19 |
| Est. Completion | 2015-10-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01622569
The ClinicalTrials.gov registry entry for NCT01622569 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 323 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.
NCT01622569 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01622569 about?
NCT01622569 is a clinical study titled "Study Evaluating the Efficacy and Safety of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi Directional Device in Subjects With Bilateral Nasal Polyposis Followed by an 8-Week Open-Label Extension Phase to Assess Safety". The primary objective of this study is to compare the efficacy of intranasal administration of 100, 200, and 400 μg of fluticasone propionate twice a day delivered by the OptiNose device with placebo in subjects with bilateral nasal polyposis. Two co-primary endpoints will be used in the study: redu...
What is the current status of trial NCT01622569?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 323 participants. The study started on 2013-11-19. Estimated completion is 2015-10-01.
What interventions are being tested in trial NCT01622569?
The interventions under investigation include: Fluticasone Propionate (DRUG).
Who is sponsoring clinical trial NCT01622569?
This trial is sponsored by Optinose US, which has 11 total clinical trials registered on ClinicalTrials.gov.
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