Study title: A double-blind, 2x2 Factohal Study to evaluate the effects of treatment with intranasal fluticasone propionate and use of Otovent mechanical ventilation of the middle ear on the need for surgery in children aged 4-8 with chronic or recurrent otitis media.
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: Study FLNL45-Fluticasone_Flixonase.xls | |||||
Document date: 2011-09-28 | |||||
Study number: FLNL45 | |||||
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 |