An Efficacy and Safety Evaluation of Nasacort AQ in Children Ages 2-5 Years With Perennial Allergic Rhinitis
Completed
Sanofi
Phase 3
2003-11-01
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.
Efficacy and Safety Study of Nasacort in Chronic Non Allergic and Non Infectious Rhinitis in Adults
Terminated
Sanofi
Phase 3
2006-04-01
To demonstrate the superiority of the clinical efficacy of 12 weeks' treatment with Nasacort
versus placebo in adult patients presenting with Chronic Non Allergic and Non Infectious
Rhinitis
Study of Triamcinolone Acetonide on the Growth Velocity of Children, Ages 3 to 9, With Perennial Allergic Rhinitis (PAR)
Completed
Sanofi
Phase 4
2007-03-01
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
Completed
Apotex Inc.
Phase 3
1969-12-31
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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