drugset / Trial / NCT01623310
12-Month OL Intranasal Fluticasone Propionate BID Using OptiNose Device
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2013-09
- Primary completion
- 2015-08
- Completion
- 2015-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluticasone propionate | Other / unclassified | 400 ug | Intranasal |