Study title: A Multi-centre, Randomised, Parallel-Group, Open-Label Study to Assess the Long-Term Safety (Including Growth) of Fluticasone Propionate 100mcg bd via the Metered-Dose Inhaler and BabyhalerTM Spacer Device Compared With Sodium Cromoglycate 5mg qds Delivered via Metered Dose Inhaler and NebuhalerTM Spacer Device in Children aged 12-47 Months With Documented Evidence of Recurrent/Persistent Asthma-Like Symptoms over a 52-Week Treatment 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-FAS30009-ICHE3.pdf | |||||
Document date: 2011-11-09 | |||||
Study number: FAS30009 | |||||
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 | - |