An Efficacy and Safety Evaluation of Nasacort AQ in Children Ages 2-5 Years With Perennial Allergic Rhinitis
The purposes of this study are:
- To demonstrate the efficacy of once daily administration of Nasacort AQ 110 µg compared
with placebo in children 2-5 years of age with perennial allergic rhinitis; and
- To assess the safety of Nasacort AQ 110 µg in children 2-5 years of age.
Study of Triamcinolone Acetonide on the Growth Velocity of Children, Ages 3 to 9, With Perennial Allergic Rhinitis (PAR)
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
A Study Comparing the Bioequivalence of Triamcinolone Acetonide Aqueous Nasal Spray (Apotex, Inc.) to That of Nasacort® AQ Nasal Spray (Sanofi-Aventis Pharmaceutical Products, Inc.) In the Treatment of Seasonal Allergic Rhinitis
A randomized, double-blind, placebo-controlled parallel-group study, comparing the
bioequivalence of triamcinolone acetonide aqueous nasal spray (Apotex, Inc.) to that of
Nasacort® AQ nasal spray (Sanofi-Aventis Pharmaceutical Products, Inc.) in the treatment of
seasonal allergic rhinitis.
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