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A 24-Week Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 186 and 372 μg of OPN-375 Twice a Day (BID) in Subjects With Chronic Rhinosinusitis With or Without the Presence of Nasal Polyps

Trial Profile

A 24-Week Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 186 and 372 μg of OPN-375 Twice a Day (BID) in Subjects With Chronic Rhinosinusitis With or Without the Presence of Nasal Polyps

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Mar 2024

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At a glance

  • Drugs Fluticasone propionate (Primary)
  • Indications Rhinosinusitis
  • Focus Registrational; Therapeutic Use
  • Acronyms ReOpen1
  • Sponsors OptiNose
  • Most Recent Events

    • 15 Mar 2024 According to OptiNose media release, the company has announced the U.S. Food and Drug Administration (FDA) has approved XHANCE (fluticasone propionate) nasal spray for the treatment of chronic rhinosinusitis without nasal polyps in patients 18 years of age and older. approval is based on the data from ReOpen Program (ReOpen 1 and ReOpen 2).
    • 18 Jan 2024 Results presented in an OptiNose Media Release.
    • 18 Jan 2024 According to an OptiNose media release, company announced publication of results from both ReOpen1 and ReOpen2 in the Journal of Allergy and Clinical Immunology: In Practice.
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