Study title: A multiple-dose, open-label, 2-way crossover study in pediatric subjects with asthma aged 1 to < 4 years to compare the systemic exposure of fluticasone propionate 88mcg administered via the hydrofluoroalkane metered-dose inhaler using the valved holding chambers, Aerochamber Plus™ and Babyhaler™, with face-masks
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-FAS10002-ICHE3.pdf | |||||
Document date: 2011-11-09 | |||||
Study number: FAS10002 | |||||
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 | - |