NCT00449072

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

A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel Group Study of the 12 Month Effect of Treatment With Once Daily Triamcinolone Acetonide (NASACORT® AQ Nasal Spray 110 μg) on the Growth Velocity of Children, 3 to 9 Years of Age, With Perennial Allergic Rhinitis (PAR)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 299 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 3 Years – 9 Years
• Healthy volunteers: Not accepted

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

Detailed description

The study consisted of: * a 4- to 6-month screening/baseline period * a 12-month (up to Day 360+/-5 days) double-blind treatment period starting on Day 1 * a 2-month follow-up period (up to Day 420+/-5 days)

Conditions

• Rhinitis, Allergic, Perennial

Interventions

Type	Name	Description
OTHER	Placebo	Placebo to TAA-AQ was administered once at the study site in each nostril during the baseline/screening period to demonstrate intranasal IP administration
OTHER	Placebo	Placebo to TAA-AQ was administered intranasally once daily in each nostril during the double-blind period
DRUG	TAA-AQ, Nasacort® AQ	110 μg TAA-AQ was administered once daily intranasally (1 spray delivering 55 μg of TAA-AQ in each nostril) during the double-blind treatment period
DRUG	Claritin®	Participants were provided Children's Claritin® Syrup (5 mg of loratadine per 5 mL), as rescue medication for the relief of allergic rhinitis (AR) symptoms, and could be used throughout the study on an as needed basis according to the Food and Drug Administration-approved manufacturer's label

Timeline

• Start date: 2007-03-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2007-03-19
• Last updated: 2012-08-10
• Results posted: 2012-08-07

Locations

1 site across 1 country: United States