Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo, in Patients With Asthma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00393991|
Recruitment Status : Completed
First Posted : October 31, 2006
Last Update Posted : June 23, 2011
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Fluticasone propionate/formoterol fumarate 100/10 Drug: Fluticasone propionate 100 Drug: Formoterol fumarate 10 Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||475 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||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|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||April 2008|
FlutiForm 100/10 μg
Drug: Fluticasone propionate/formoterol fumarate 100/10
FlutiForm 100/10ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
Other Name: Flutiform 100/10
Active Comparator: 2
Fluticasone 100 μg
Drug: Fluticasone propionate 100
Fluticasone 100ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.
Other Name: SKP Fluticasone 100
Active Comparator: 3
Formoterol 10 μg
Drug: Formoterol fumarate 10
Formoterol 10ug is a HFA pMDI that delivers 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
Other Name: SKP Formoterol 10
Placebo Comparator: 4
Placebo is a HFA pMDI that delivers placebo aerosol. Patients will take 2 actuations BID for 12 weeks.
Other Name: SKP Placebo
- Change in Forced Expiratory Volume in 1 s (FEV-1) over 12 weeks recorded in electronic diary. Discontinuation due to lack of efficacy [ Time Frame: Week 0 and 12 visits ]
- Other pulmonary function tests including forced vital capacity (FVC) and peak expiratory flow rate (PEFR). [ Time Frame: Whole duration of study ]
- Clinical endpoints (frequency of asthma exacerbations and patient data captured in diary including daily morning and evening PEFR). [ Time Frame: Whole duration of study ]
- Safety variables including adverse events, ECGs, clinical laboratory tests and vital signs. [ Time Frame: Whole duration of study ]
- Serial 12-hour FEV-1 area under the curve (AUC). [ Time Frame: Week 0, 2 and 12 visits ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00393991