Study title: A randomized, multi-centre, double-blind, double-dummy placebo controlled single-dose cross-over study to demonstrate that 12 and 24 mg of formoterol delivered by concept1 has a bronchodilator efficacy which is equivalent to the same dose of formoterol de
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: CFOR258D2201 | |||||
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) |
- | - | - | - | - |