Study title: FLU9705: a multi-centre, parallel group, randomised, double-blind study to investigate the efficacy of fluticasone propionate 100 mcg MDI bd versus placebo MDI bd both via Babyhaler™ spacer in 1 to 5 year old children with asthma or asthma-like symptoms during a 6 months study period.
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-FMS40256-ICHE3.pdf | |||||
Document date: 2011-11-09 | |||||
Study number: FLU9705: FMS40256 | |||||
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 | - |