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 μg of Fluticasone Propionate

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 μg of Fluticasone Propionate

Completed
Phase of Trial: Phase III

Latest Information Update: 22 Jul 2017

At a glance

  • Drugs Fluticasone propionate (Primary)
  • Indications Nasal congestion; Nasal polyps
  • Focus Registrational; Therapeutic Use
  • Acronyms NAVIGATE II
  • 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.
    • 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.
    • 16 Sep 2016 Results from this trial were presented at the American Rhinologic Societys Annual Meeting, according to an Optinose media release
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