New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) in Patients With Asthma

Phase 3 Completed 400 enrolled SkyePharma AG

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the long-term safety of the fixed combination asthma drug FlutiForm HFA MDI (containing fluticasone propionate and formoterol fumarate) in adult and adolescent patients with mild to moderate-severe asthma.

Timeline

Start: 2006-03
Primary completion: 2007-07
Completion: 2007-07

Publications

Mansur AH, Kaiser K. Long-term safety and efficacy of fluticasone/formoterol combination therapy in asthma. J Aerosol Med Pulm Drug Deliv. 2013 Aug;26(4):190-9. doi: 10.1089/jamp.2012.0977. Epub 2012 Oct 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fluticasone propionate	Other / unclassified	100 ug	Inhaled
Subject	Fluticasone propionate	Other / unclassified	250 ug	Inhaled
Subject	Formoterol	Other / unclassified	10 ug	Inhaled

New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) in Patients With Asthma

Summary

Timeline

Publications

Drugs

Indications