A 16-Week Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 100, 200, and 400 microg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi Directional Device in Subjects With Bilateral Nasal Polyposis Followed by an 8-Week Open-Label Extension Phase to Assess Safety

Trial Profile

A 16-Week Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 100, 200, and 400 microg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi Directional Device in Subjects With Bilateral Nasal Polyposis Followed by an 8-Week Open-Label Extension Phase to Assess Safety

Completed
Phase of Trial: Phase III

Latest Information Update: 22 Jul 2017

At a glance

  • Drugs Fluticasone propionate (Primary)
  • Indications Nasal polyps; Rhinosinusitis
  • Focus Registrational; Therapeutic Use
  • Acronyms NAVIGATE I
  • Sponsors OptiNose
  • Most Recent Events

    • 09 May 2017 According to a OptiNose media release, The FDA has set a target date to complete its review of the NDA under the Prescription Drug User Fee Act (PDUFA) of September 2017.
    • 06 Mar 2017 Results presented at the 2017 Annual Meeting of the American Academy of Allergy, Asthma and Immunology
    • 31 Jan 2017 According to an OptiNose media release, the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) for the investigational new product OPN-375.
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