The primary objective of the study is to assess the efficacy of high dose fluticasone propionate (Fp)/albuterol sulfate (ABS) integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS eMDPI in decreasing severe clinical asthma exacerbation (CAEs). Secondary Objectives: To evaluate the efficacy of Fp/ABS low dose compared to ABS and the effect on systemic corticosteroid (SCS) exposure To evaluate the safety and tolerability of Fp/A BS The duration for each participant will be a minimum of 28 weeks including 2 weeks of screening, 2-4 weeks of run-in period and a double blind treatment period of minimum 24 weeks, however due to the event-driven nature of this study, the duration may range up to approximately 42 months depending on the timing when the participant was enrolled to the study, and when the study reaches its completion criteria
Fluticasone Propionate/Salbutamol Sulfate. Oral inhalation powder.
Oral inhalation powder
Bahía Blanca, Argentina
Bahía Blanca, Argentina
Bahía Blanca, Argentina
Buenos Aires, Argentina
Buenos Aires, Argentina
Buenos Aires, Argentina
Buenos Aires, Argentina
Buenos Aires Province, Argentina
CABA, Argentina
CABA, Argentina
CapitalFederal, Argentina
Concepción del Uruguay, Argentina
Córdoba, Argentina
Florida, Vicente Lopez, Argentina
Godoy Cruz, Argentina
Lanús Este, Argentina
Lobos, Argentina
Mar del Plata, Argentina
Mendoza, Argentina
Mendoza, Argentina
Mendoza, Argentina
Mendoza, Argentina
Paraná, Argentina
Quilmes, Argentina
Rosario, Argentina
Rosario, Argentina
Rosario, Argentina
San Fernando, Argentina
San Juan Bautista, Argentina
San Miguel de Tucumán, Argentina
San Miguel de Tucumán, Argentina
San Miguel de Tucumán, Argentina
San Miguel de Tucumán, Argentina
San Rafael, Argentina
Santa Fe, Argentina