Conditions: Rhinitis, Allergic, Perennial
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 299
Healthy volunteers: no

Brief 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)

Arms:
arm 1: 3 to 9 year old participants with Perennial Allergic Rhinitis (PAR) administered

* Placebo in the baseline/screening period to demonstrate administration of investigational product (IP) with the nasal spray bottle
* Placebo in the double-blind treatment period

All participants were provided Children's Claritin® Syrup as a rescue medication. arm 2: 3 to 9 year old participants with Perennial Allergic Rhinitis (PAR) administered

* Placebo in the baseline/screening period to demonstrate administration of IP with the nasal spray bottle
* Triamcinolone acetonide (TAA-AQ) in the double-blind treatment period

All participants were provided Children's Claritin® Syrup as a rescue medication.

Interventions: intervention 1: Placebo intervention 2: Placebo intervention 3: TAA-AQ, Nasacort® AQ intervention 4: Claritin®
Intervention descriptions: intervention 1: Placebo to TAA-AQ was administered once at the study site in each nostril during the baseline/screening period to demonstrate intranasal IP administration intervention 2: Placebo to TAA-AQ was administered intranasally once daily in each nostril during the double-blind period intervention 3: 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 intervention 4: 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

Protocol document: