Conditions: Asthma
Keywords: ADVAIR Asthma safety FLOVENT
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 11751
Healthy volunteers: no

Brief summary:
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.

Detailed description:
Progress of Enrollment, Updated Annually: This study has been completed and the final clinical study report was submitted to the FDA in January of 2016. This is the final update, as this study is complete.

Arms:
arm 1: experimental drug arm 2: experimental drug arm 3: experimental drug arm 4: active comparator arm 5: active comparator arm 6: active comparator

Interventions: intervention 1: ADVAIR 100/50mcg intervention 2: ADVAIR 250/50mcg intervention 3: ADVAIR 500/50mcg intervention 4: FLOVENT 100mcg intervention 5: FLOVENT 250mcg intervention 6: FLOVENT 500mcg
Intervention descriptions: intervention 1: fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months intervention 2: fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months intervention 3: fluticasone propionate/salmeterol combination (500/50mcg) twice daily (AM and PM) for 6 months intervention 4: fluticasone propionate (100) twice daily (AM and PM) for 6 months intervention 5: fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months intervention 6: fluticasone propionate (500mcg) twice daily (AM and PM) for 6 months

Protocol document: