12-Month OL Evaluating the Safety of Intranasal Administration Fluticasone BID Using OptiNose Device in Subjects With CS With or Without Nasal Polyps
Phase of Trial: Phase III
Latest Information Update: 05 Mar 2018
At a glance
- Drugs Fluticasone propionate (Primary)
- Indications Sinusitis
- Focus Adverse reactions; Registrational
- Acronyms EXHANCE-12
- Sponsors OptiNose
- 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.
- 09 May 2017 According to a OptiNose media release, The FDA has set a target date to complete its review of the NDA under the Prescription Drug User Fee Act (PDUFA) of September 2017.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History