Conditions: Asthma
Keywords: Asthma fluticasone salmeterol CRC749 Diskus Advair FEV1 MGR001
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1128
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether MGR001 is equivalent to Advair Diskus when administered by inhalation in adult asthma patients

Detailed description:

Arms:
arm 1: MGR001 administered two times per day by inhalation throughout the study arm 2: Advair Diskus administered two times per day by inhalation throughout the study arm 3: Placebo for Advair Diskus and MGR001 administered two times per day by inhalation throughout the study

Interventions: intervention 1: MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate) intervention 2: Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate) intervention 3: Placebo
Intervention descriptions: intervention 1: Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the CRC749 inhaler device intervention 2: Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Diskus inhaler device intervention 3: Placebo administered via the CRC749 and Diskus devices

Protocol document: