Study title: Prevention of Otitis media in children." 6) "A randomized, double-blind, placebo-controlled study examining the effect of fluticasone propionate aqueous nasal spray in antibiotic therapy in the treatment of chronic rhinosinusitis in paediatric patients."
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Otorhinolaryngologic Diseases [C09] | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: FLUTICASONE | |||||
ATC code: | |||||
Document link: Fluticasone-Propionate-FNM40083-ICHE3.pdf | |||||
Document date: 2011-09-28 | |||||
Study number: FNM40083, FLNQ03 | |||||
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 |