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: 05 Mar 2018

At a glance

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

    • 05 Mar 2018 Results assessing the effect of Exhalation Delivery System with Fluticasone on Health-Related Quality of Life (n=242), presented at the 2018 Annual Meeting of the American Academy of Allergy, Asthma and Immunology
    • 27 Feb 2018 According to an Optinose pharmaceutical media release, the Company will present data from this trial at the American Academy of Allergy, Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress (2018).
    • 18 Sep 2017 According to an OptiNose media release, the U.S. Food & Drug Administration (FDA) approved the Company's New Drug Application (NDA) for XHANCE for the treatment of nasal polyps in patients 18 years of age and older.
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