SAS115359, a Safety and Efficacy Study of Inhaled Fluticasone Propionate/Salmeterol Combination versus Inhaled Fluticasone Propionate in the Treatment of Adolescent and Adult Subjects with Asthma.
The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in adolescents and adults (12 years of age and older) taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.
ADVAIR™ and FLOVENT™ are trademarks of the GlaxoSmithKline Group of Companies.
Study Type: Interventional
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: SAS115359, a Safety and Efficacy Study of Inhaled Fluticasone Propionate/Salmeterol Combination Versus Inhaled Fluticasone Propionate in the Treatment of Adolescent and Adult Subjects With Asthma
Study Start Date: November 2011
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
- Experimental: ADVAIR 100/50mcg
- Experimental: ADVAIR 250/50mcg
- Experimental: ADVAIR 500/50mcg
- Active Comparator: FLOVENT 100mcg
- Active Comparator: FLOVENT 250mcg
- Active Comparator: FLOVENT 500mcg
|Study start date||2011-11-01|