Conditions: Asthma
Keywords: asthma fluticasone propionate children fluticasone propionate/salmeterol
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 351
Healthy volunteers: no

Brief summary:
This study is to assess the safety of an investigational drug in children 4 to 11 years of age who have asthma. The subjects will attend 7 clinic visits, of which up to 3 will be in the morning, and have lung function tests performed.

Detailed description:

Arms:
arm 1: Fluticasone propionate/salmeterol 100/50 HFA (2 inhalations of 50/25mcg), twice daily (strengths are ex-valve) and a placebo HFA inhaler matching the fluticasone propionate 100mcg HFA inhaler (2 inhalations) twice daily arm 2: Fluticasone propionate 100mcg HFA (2 inhalations of 50mcg), twice daily (strengths are ex-valve) and a placebo HFA inhaler matching the fluticasone propionate/salmeterol 100/50 HFA inhaler (2 inhalations ) twice daily

Interventions: intervention 1: fluticasone propionate intervention 2: fluticasone propionate/salmeterol
Intervention descriptions: intervention 1: fluticasone propionate 100mcg HFA intervention 2: fluticasone propionate/salmeterol 100/50mcg HFA

Protocol document: