drugset / Trial / NCT00449072

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

NCT00449072

Phase 4 Completed 299 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

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

Timeline

Start
2007-03
Primary completion
2011-10
Completion
2011-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Triamcinolone Acetonide Other / unclassified 110 ug Intranasal
Comparator Loratadine Small molecule 5 mg