Clinical Trial: Study Evaluating the Safety of Intranasal Administration of 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi-Directional Device in Subjects With Chronic Sinusitis With or Without Nasal Polyps

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A 3-Month Open-Label Multicenter Study Evaluating the Safety of Intranasal Administration of 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi-Directional Device in Subjects Wit

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 Summary:
Sponsor: Optinose US Inc.

Current Primary Outcome: Adverse Events [ Time Frame: Baseline to 3 months or End of Study ]

Adverse Events were collected via spontaneous subject report and through physician examination. The display of adverse events is by subject.


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Optinose US Inc.

Dates:
Date Received: June 14, 2012
Date Started: September 2013
Date Completion:
Last Updated: August 25, 2016
Last Verified: August 2016