Trials / Completed
CompletedNCT01623310
12-Month OL Intranasal Fluticasone Propionate BID Using OptiNose Device
12-Month OL Evaluating the Safety of Intranasal Administration Fluticasone BID Using OptiNose Device in Subjects With CS With or Without Nasal Polyps
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 223 (actual)
- Sponsor
- Optinose US Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 12-month open-label treatment phase. The duration of each subject's participation is approximately 53 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fluticasone Propionate | Using Optinose Exhalation Delivery System |
Timeline
- Start date
- 2013-09-01
- Primary completion
- 2015-08-01
- Completion
- 2015-10-01
- First posted
- 2012-06-19
- Last updated
- 2018-01-24
- Results posted
- 2018-01-24
Locations
16 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01623310. Inclusion in this directory is not an endorsement.