Study title: A multi-centre, randomised, double-blind, double-dummy, parallel-group study to determine the clinical equivalence between fluticasone propionate 100μg twice daily delivered via a multidose powder inhaler (MDPI) and the Diskhaler™ in adult and paediatric patients with reversible airways disease.
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-FMDT02-ICHE3.pdf | |||||
Document date: 2011-11-09 | |||||
Study number: FMDT02: FLTB3008 | |||||
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 |