Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone & Formoterol Administered Alone in Patients With Asthma
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|ClinicalTrials.gov Identifier: NCT00394199|
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||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||357 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Double-blind, Active-controlled, Parallel Group, 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 Fluticasone (100 µg Twice Daily) and Formoterol (10 µg Twice Daily) Alone in Adolescent & Adult Patients With Mild to Moderate Asthma|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
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
Drug: Fluticasone propionate 100
Fluticasone 100 is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.
Other Name: Fluticasone 100
Active Comparator: 3
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
- Change in Forced Expiratory volume in 1 s (FEV-1) from morning predose at Baseline (Week 0) to predose at Week 12 [ Time Frame: Week 0 and 12 ]
- 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 include adverse events, ECGs, clinical laboratory tests and vital signs. [ Time Frame: Whole duration of study ]
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): NCT00394199