Study title: A randomized, double-blind, double dummy, parallel group comparison of fluticasone propionate inhalation powder (50mcg BID) via DiskusTM with oral montelukast (5mg QD) chewable tablets in children 6–12 years of age with persistent asthma
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Respiratory Tract Diseases [C08] | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: FLUTICASONE | |||||
ATC code: | |||||
Document link: Fluticasone-Propionate-FPD40013-ICHE3.pdf | |||||
Document date: 2011-11-09 | |||||
Study number: FPD40013 | |||||
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 | Y |