Conditions: Asthma
Keywords: pediatric ADVAIR FLOVENT asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 6250
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 children 4-11 years old taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.

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

Arms:
arm 1: fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months arm 2: fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months arm 3: fluticasone propionate (100) twice daily (AM and PM) for 6 months arm 4: fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months

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

Protocol document: