Study title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Potential Effects of a Six-Week Course of Fluticasone Propionate Aqueous Nasal Spray (200mcg QD) on the HPA-Axis in ≥2 and <4 Year Old Subjects with Allergic Rhinitis.
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-FNM40183-ICHE3.pdf | |||||
Document date: 2011-09-28 | |||||
Study number: FNM40183 | |||||
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 | - |