An Open-Label, 2-Part, Randomized, Crossover Study to Compare the Bioavailability of Intranasal Administration of 200 and 400 µg of OPTINOSE FLUTICASONE With 400 µg of Flonase (Fluticasone Propionate) Nasal Spray (Part 1), and Intranasal Administration of 200 and 400 µg or 400 µg Alone of OPTINOSE FLUTICASONE With 440 µg of Flovent HFA (Fluticasone Propionate) Inhalation Aerosol (Part 2) (Current Investigation is Part 2 Only)
Phase of Trial: Phase I
Latest Information Update: 18 Sep 2017
At a glance
- Drugs Fluticasone propionate (Primary)
- Indications Asthma
- Focus Pharmacokinetics
- Sponsors OptiNose
- 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.
- 06 Mar 2017 Results of Part I and Part II studies assessing bioavailability of FLU-EDS, presented at the 2017 Annual Meeting of the American Academy of Allergy, Asthma and Immunology.