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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Sep 2020

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At a glance

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

    • Most Recent Events

    • 29 Sep 2020 Post-hoc analysis data from NAVIGATE I and II trials presented in an Optinose pharmaceutical media release.
    • 29 Sep 2020 According to an Optinose pharmaceutical media release, post-hoc analysis data from NAVIGATE I and II trials were published in the International Forum of Allergy & Rhinology, the journal of the American Rhinologic Society.
    • 04 Aug 2020 According to an Optinose pharmaceutical media release, Pooled analysis of the Company's NAVIGATE I and II phase 3 clinical trials highlighting improvement in quality of life and health status measures were published in the International Forum of Allergy & Rhinology.

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