Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone & Formoterol Administered Alone in Patients With Asthma

Phase 3 Completed 357 enrolled SkyePharma AG

RandomizedParallel-groupTriple-blindTreatment

Summary

To compare the efficacy and safety of the fixed combination asthma drug Flutiform HFA MDI with its two components administered alone, fluticasone propionate and formoterol fumarate, in adult and adolescent patients with mild to moderate asthma.

Timeline

Start: 2006-06
Primary completion: 2008-02
Completion: 2008-02

Outcome

Met primary endpoint

paper Statistically significant differences were demonstrated for the 2 coprimary end points. PMID 23870606 ↗

paper Fluticasone/formoterol combination therapy showed significantly greater improvements from baseline to end of study in the change in predose FEV(1) compared with formoterol PMID 23870606 ↗

Publications

Pearlman DS, LaForce CF, Kaiser K. Fluticasone/Formoterol combination therapy compared with monotherapy in adolescent and adult patients with mild to moderate asthma. Clin Ther. 2013 Jul;35(7):950-66. doi: 10.1016/j.clinthera.2013.05.012.

Drugs

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