Who is sponsoring NCT00393991?

NCT00393991 is sponsored by SkyePharma AG.

What drugs are being tested in NCT00393991?

Interventions: Fluticasone propionate/formoterol fumarate 100/10, Fluticasone propionate 100, Formoterol fumarate 10, Placebo.

What is the status of NCT00393991?

NCT00393991 is currently COMPLETED.

Last reviewed 2011-06-08 · How we verify

A Randomized, Double-blind, Placebo-controlled, Parallel, Stratified, Multi-center, 12-Week Study Comparing the Safety & Efficacy of Fluticasone and Formoterol Combination (FlutiForm(tm)100/10 µg Twice Daily) in a Single Inhaler (SkyePharma HFA pMDI)With the Administration of Placebo or Fluticasone (100 µg Twice Daily) and Formoterol (10 µg Twice Daily) Alone in Adolescent and Adult Patients With Mild to Moderate Asthma

NCT00393991 Phase 3 COMPLETED

The purpose of this study is 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, and with placebo in adult and adolescent patients with mild to moderate asthma.

Details

Lead sponsor	SkyePharma AG
Phase	Phase 3
Status	COMPLETED
Enrolment	475
Start date	2006-07
Completion	2008-04

Conditions

Asthma

Interventions

Fluticasone propionate/formoterol fumarate 100/10
Fluticasone propionate 100
Formoterol fumarate 10
Placebo

Primary outcomes

Change in Forced Expiratory Volume in 1 s (FEV-1) over 12 weeks recorded in electronic diary. Discontinuation due to lack of efficacy — Week 0 and 12 visits

Countries

United States, Canada