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12-Month OL Evaluating the Safety of Intranasal Administration Fluticasone BID Using OptiNose Device in Subjects With CS With or Without Nasal Polyps

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Trial Profile

12-Month OL Evaluating the Safety of Intranasal Administration Fluticasone BID Using OptiNose Device in Subjects With CS With or Without Nasal Polyps

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Fluticasone propionate (Primary)
  • Indications Sinusitis
  • Focus Adverse reactions; Registrational
  • Acronyms EXHANCE-12
  • Sponsors OptiNose

    • Most Recent Events

    • 21 Jun 2018 According to an OptiNose media release, data from this trial were presented in the International Forum of Allergy & Rhinology.
    • 05 Mar 2018 Results of pooled data from EXHANCE-3 and EXHANCE-12 assessing Exhalation Delivery System with Fluticasone treatment outcomes for CRSsNP patients with and without a recent INS, were presented at the 2018 Annual Meeting of the American Academy of Allergy, Asthma and Immunology.
    • 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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