Trial Profile
A 3-Month Open-Label Multicenter Study Evaluating the Safety of Intranasal Administration of 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi-Directional Device in Subjects With Chronic Sinusitis With or Without Nasal Polyps
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 08 Nov 2021
Price :
$35
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At a glance
- Drugs Fluticasone propionate (Primary)
- Indications Nasal polyps; Rhinitis; Rhinosinusitis; Sinusitis
- Focus Adverse reactions
- Acronyms EXHANCE-3
- 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.