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NCT01624662 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Using a Novel Bi-directional Device
A Phase 3 study of Bilateral Nasal Polyposis, sponsored by Optinose US.
- Completed
- Registry status
- Phase 3
- Development phase
- 323
- Enrollment target
- 10
- Study locations
NCT01624662: Completed Phase 3 study of Bilateral Nasal Polyposis, sponsored by Optinose US.
NCT01624662 is a Phase 3 study of Bilateral Nasal Polyposis that has completed, run by Optinose US. The registered enrollment target is 323 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01624662, a Phase 3 study of Bilateral Nasal Polyposis, has completed, sponsored by Optinose US.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 323 participants
- Enrollment target
- 10
- Study locations
Study Summary
The primary objective of this study was to compare the efficacy of intranasal administration of 100, 200, and 400 μg twice daily (bid) of fluticasone propionate, delivered by the Optinose device, with matching placebo in subjects with bilateral nasal polyposis and nasal congestion.
Primary Outcome
Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing. 0: None 1. Mild, symptoms clearly present, but minimal awareness, and easily tolerated 2. Moderate, definite awareness of symptoms that is bothersome but tolerable 3. Severe, symptoms that are hard to tolerate, cause interference with activities or daily living During the single-blind run-in phase and during the 16-week, double-blind treatment phase, an electronic diary was provided to each subj
Conditions Studied
Interventions
- DRUG Fluticasone propionate
Study Locations (10)
Oregon
- Allergy and Asthma Research Group - Eugene
- Baker Allergy, Asthma and Dermatology Research Center, LLC - Lake Oswego
California
- Bensch Clinical Research LLC - Stockton
Colorado
- Colorado Allergy & Asthma Centers, PC - Centennial
Kentucky
- Advanced ENT and Allergy - Louisville
Maryland
- Institute for Asthma and Allergy - Wheaton
New Jersey
- Atlantic Research Center, LLC - Ocean City
Pennsylvania
- Valley Clinical Research Center - Bethlehem
Vermont
- University of Vermont - Burlington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 323 participants |
| Start Date | 2013-10-30 |
| Est. Completion | 2015-07-03 |
| Phase | Phase 3 |
What the finished NCT01624662 record still lists
NCT01624662 is an interventional study that assigns participants to a tested intervention. The registered 323 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 (58% lower).
The record links to 1 condition, with Bilateral Nasal Polyposis appearing as the primary indexed condition, and to 1 intervention - of which Fluticasone propionate is the first listed.
NCT01624662 lists 10 locations in 9 states (Oregon, California, Colorado).
Frequently Asked Questions
What is clinical trial NCT01624662 about?
NCT01624662 is a clinical study titled "Efficacy and Safety Study of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Using a Novel Bi-directional Device". The primary objective of this study was to compare the efficacy of intranasal administration of 100, 200, and 400 μg twice daily (bid) of fluticasone propionate, delivered by the Optinose device, with matching placebo in subjects with bilateral nasal polyposis and nasal congestion.
What is the current status of trial NCT01624662?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 323 participants. The study started on 2013-10-30. Estimated completion is 2015-07-03.
What conditions does trial NCT01624662 study?
This clinical trial studies the following conditions: Bilateral Nasal Polyposis.
What interventions are being tested in trial NCT01624662?
The interventions under investigation include: Fluticasone propionate (DRUG).
Who is sponsoring clinical trial NCT01624662?
This trial is sponsored by Optinose US, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01624662 being conducted?
This trial has 10 study locations across California, Colorado, Kentucky, Maryland, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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323 1081st of 2000 higher than 920 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
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