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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 Sinusitis 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 Sinusitis With or Without the Presence of Nasal Polyps

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 14 Nov 2019

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At a glance

  • Drugs Fluticasone propionate (Primary)
  • Indications Chronic sinusitis
  • Focus Registrational; Therapeutic Use
  • Sponsors OptiNose
  • Most Recent Events

    • 12 Nov 2019 According to an OptiNose media release, the company expects to report topline data from this trial in the second half of 2021.
    • 06 Mar 2019 According to an OptiNose media release, this trial is the first of two anticipated phase 3b clinical trials (CT profiles 294122 and 305310) of XHANCE for which Company plans to seek approval for a follow-on indication for the treatment of chronic sinusitis in the U.S. in order to broaden its market opportunity.
    • 10 Dec 2018 According to an OptiNose media release, first patient has been enrolled in the trial.
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