The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in adolescents and adults (12 years of age and older) taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone. ADVAIR™ and FLOVENT™ are trademarks of the GlaxoSmithKline Group of Companies.
Progress of Enrollment, Updated Annually: This study has been completed and the final clinical study report was submitted to the FDA in January of 2016. This is the final update, as this study is complete.
fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months
fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months
fluticasone propionate/salmeterol combination (500/50mcg) twice daily (AM and PM) for 6 months
fluticasone propionate (100) twice daily (AM and PM) for 6 months
fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months
fluticasone propionate (500mcg) twice daily (AM and PM) for 6 months
Derqui, Pilar, Buenos Aires, Argentina
Nueve de Julio, Buenos Aires, Argentina
San Martín, Buenos Aires, Argentina
Concepción del Uruguay, Entre Ríos Province, Argentina
Paraná, Entre Ríos Province, Argentina
Rosario, Santa Fe Province, Argentina
San Miguel de Tucumán, Tucumán Province, Argentina
Buenos Aires, Argentina
Buenos Aires, Argentina
Buenos Aires, Argentina
Buenos Aires, Argentina
La Plata, Argentina
Lanús, Argentina
Mendoza, Argentina
Rosario, Argentina