Study title: A Stratified, Multicenter, Randomized, Double-Blind, Parallel Group, 4-Week Comparison of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg BID versus Fluticasone Propionate DISKUS 100mcg BID in Pediatric and in Adolescent Subjects with Activity-Induced Bronchospasm
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Respiratory Tract Diseases | |||||
Brands: Please see report | |||||
MAH holders: Please see report, Please see report | |||||
Assessment: | |||||
Active substance: FLUTICASONE AND SALMETEROL | |||||
ATC code: | |||||
Document link: Fluticasone-Propionate-Sameterol-SFA100316-ICHE3.pdf | |||||
Document date: 2011-09-30 | |||||
Study number: SFA100316 | |||||
EudraCT number: | |||||
Scope of study: CLINICAL | |||||
Population of study subjects: | Preterm newborn Infants | Newborn infants (1 to 27 days) | Infants and toddlers (28 days to 24 months) | Children (2 to 11 years) | Adolescents (12 to 18 years) |
- | - | - | - | Y |