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Sponsored by: |
SkyePharma AG |
Information provided by: | SkyePharma AG |
ClinicalTrials.gov Identifier: | NCT00394199 |
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.
Condition | Intervention | Phase |
Asthma |
Drug: Fluticasone propionate/Formoterol Fumarate |
Phase III |
MedlinePlus related topics: | Asthma |
ChemIDplus related topics: | Fluticasone propionate Fluticasone Formoterol Arformoterol Arformoterol Tartrate Formoterol fumarate HFA 227 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 350 |
Study Start Date: | June 2006 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients will not be eligible for the study if they meet any of the following criteria:
Show 41 Study Locations |
SkyePharma AG |
Study ID Numbers: | SKY2028-3-002 |
First Received: | October 27, 2006 |
Last Updated: | May 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00394199 |
Health Authority: | United States: Food and Drug Administration |
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