Study title: A randomized, multicenter, double-blind, double-dummy, placebo controlled, cross-over dose ranging study to evaluate the safety and efficacy of single doses of formoterol fumarate (6,12 and 24 ug) via an hfa pmdi versus placebo and versus formoterol fumar
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Respiratory Tract Diseases | |||||
Brands: | |||||
MAH holders: Please see report, Please see report | |||||
Assessment: | |||||
Active substance: FORMOTEROL | |||||
ATC code: R03A C13 | |||||
Document link: | |||||
Document date: | |||||
Study number: CFOR258I2202 | |||||
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) |
- | - | - | - | - |