Conditions: Nasal Polyps
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 223
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: OPN-375 400 μg BID for 12 months

Interventions: intervention 1: Fluticasone Propionate
Intervention descriptions: intervention 1: Using Optinose Exhalation Delivery System

Protocol document: