SAS115359: A 6-month Study to Assess the Safety and Benefit of Inhaled Fluticasone Propionate/Salmeterol Combination Compared With Inhaled Fluticasone Propionate in the Treatment of Adolescents and Adults (12 Years of Age and Older) With Asthma. (AUSTRI)
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
Related journal: Serious Asthma Events with Fluticasone plus Salmeterol versus Fluticasone Alone.
|Study start date||2011-11-01|