CompletedPhase 3

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

United States705 participantsStarted 2013-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. nasal blockage/congestion
✓. nasal discharge (anterior and/or posterior nasal discharge)
✓. facial pain or pressure
✓. reduction or loss of smell

What they're measuring

Adverse Events

Timeframe: Baseline to 3 months or End of Study

Trial details

NCT IDNCT01623323

SponsorOptinose US Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-03

Results submitted2016-02-02

View on ClinicalTrials.gov More Chronic Sinusitis With or Without Nasal Polyps trials