NCT02266927

A Study to Compare the Bioavailability 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)

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Optinose US Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

To compare the systemic exposure of a single dose of 400 µg of OPTINOSE FLUTICASONE with 440 µg of Flovent® HFA (fluticasone propionate) Inhalation Aerosol in asthmatic subjects.

Conditions

• Mild to Moderate Asthma

Interventions

Type	Name	Description
DRUG	Flovent HFA
DRUG	OPTINOSE™ FLUTICASONE

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-03-01
• Completion: 2015-04-01
• First posted: 2014-10-17
• Last updated: 2016-02-03

Locations

1 site across 1 country: Ireland