A 6-month Safety and Benefit Study of Inhaled Fluticasone Propionate/ Salmeterol Combination Versus Inhaled Fluticasone Propionate in the Treatment of 6,200 Pediatric Subjects 4-11 Years Old With Persistent Asthma
A 6-month Safety and Benefit Study of Inhaled Fluticasone Propionate/ Salmeterol Combination Versus Inhaled Fluticasone Propionate in the Treatment of 6,200 Pediatric Subjects 4-11 Years Old With Persistent Asthma
The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in children 4-11 years old taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.
Progress of Enrollment, Updated Annually: This study has been completed and the final clinical study report was submitted to the FDA in May of 2016. This is the final update, as this study is complete.
Inclusion Criteria:
Exclusion Criteria:
Dothan, Alaska 36305, United States
Rolling Hills Est., California 920274, United States
Wheeling, Ohio 26003, United States
Ciudad Autonoma de Buenos Aires, Buenos Aires C1122AAK, Argentina
Capital Federal, C1270AAN, Argentina
Kleve-Materborn, North Rhine-Westphalia 47533, Germany
Dasmariñas, Cavite, 4114, Philippines
St'Petersburg, 191144, Russia
Pozuelo de Alarcón/Madrid, 28223, Spain
Bangkoknoi, 10700, Thailand
Ratchatewi, 10400, Thailand
Zaporizhia, 69063, Ukraine
Merseyside, CH41 0DD, United Kingdom
Surrey, RH1 5RH, United Kingdom