Overview

Study of Triamcinolone Acetonide on the Growth Velocity of Children, Ages 3 to 9, With Perennial Allergic Rhinitis (PAR)

Status:
Completed
Trial end date:
2011-10-01
Target enrollment:
Participant gender:
Summary
The primary objective of the study was to characterize the difference in prepubescent growth velocity in children 3 to 9 years of age with perennial allergic rhinitis (PAR) treated with triamcinolone acetonide (TAA) nasal spray (NASACORT® AQ 110 μg treatment group) or placebo (NASACORT® AQ placebo group) for 12-months. The secondary objectives were to compare the following in prepubertal participants treated with TAA nasal spray versus placebo: - the 24-hour urinary free cortisol levels and the cortisol/creatinine ratio (to measure the Hypothalamic-Pituitary Adrenal [HPA] axis function) - the rate of treatment-emergent-adverse-events (TEAE) - global efficacy rated by the investigator and the participant separately - the rate of use of rescue medication during the study
Phase:
Phase 4
Details
Lead Sponsor:
Sanofi
Treatments:
Loratadine
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide