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)

NCT02266927 Phase 1 COMPLETED

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.

Details

Lead sponsor	Optinose US Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	28
Start date	2014-09
Completion	2015-04

Conditions

• Mild to Moderate Asthma

Interventions

• Flovent HFA
• OPTINOSE™ FLUTICASONE

Primary outcomes

• The ratio of least-squares means of the ln transformed PK parameter AUC0-∞ is the primary endpoint. — Pre-dose and at 0.167, 0.333, 0.5, 0.75, 1, 1.333, 1.667, 2, 2.5, 3, 4, 6, 9, 12, 16, 24, and 36 hours after dosing
  Part 2

Countries

Ireland