drugset / Trial / NCT00393952

New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo in Patients With Moderate to Severe Asthma

NCT00393952

Phase 3 Completed 557 enrolled SkyePharma AG
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to compare the efficacy and safety of the fixed combination asthma drug FlutiForm with its two components administered alone, fluticasone propionate and formoterol fumarate, and with placebo in adult and adolescent patients with moderate to severe asthma.

Timeline

Start
2006-06
Primary completion
2008-04
Completion
2008-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluticasone propionate Other / unclassified 100 ug Inhaled
Comparator Fluticasone propionate Other / unclassified 250 ug Inhaled
Comparator Formoterol Other / unclassified 10 ug Inhaled

Indications