Conditions: Asthma
Keywords: fluticasone propionate long-term study Salmeterol FLOVENT 250 Asthma ADVAIR 250
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 621
Healthy volunteers: no

Brief summary:
This purpose of this study is to show the superiority and long term safety and efficacy of adding a long acting beta agonist (salmeterol) to constant dose of an inhaled corticosteroid (fluticasone propionate) in symptomatic subjects with asthma. The 12-month assessment of asthma control will provide key information on the efficacy and safety of the combination therapy. The safety measure will be an assessment of adverse events

Detailed description:

Arms:
arm 1: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID arm 2: Fluticasone propionate 250 mcg BID

Interventions: intervention 1: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID intervention 2: Fluticasone propionate 250 mcg BID
Intervention descriptions: intervention 1: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID intervention 2: Fluticasone propionate 250 mcg BID

Protocol document: