Conditions: Chronic Sinusitis With or Without Nasal Polyps
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 705
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 3-month open-label treatment phase. The duration of each subject's participation is approximately 13 weeks.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Fluticasone Propionate
Intervention descriptions: intervention 1: Fluticasone Propionate 400 μg

Protocol document: