Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 879
Healthy volunteers: no

Brief summary:
This is a study to establish the equivalence of OT329 Solis and Advair Diskus when administered by inhalation in patients with asthma.

Detailed description:

Arms:
arm 1: OT329 Solis (twice daily inhalation throughout the study) arm 2: Advair Diskus (twice daily inhalation throughout the study) arm 3: Placebo (twice daily inhalation throughout the study)

Interventions: intervention 1: OT329 (combination of fluticasone propionate and salmeterol xinafoate) intervention 2: Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate) intervention 3: Placebo
Intervention descriptions: intervention 1: Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler intervention 2: Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler intervention 3: Placebo (lactose) administered via the Solis dry powder inhaler

Protocol document: