Rhinitis, Allergic, Perennial and/or Seasonal Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Pharmacodynamic Effect of a 6-week Treatment With Triamcinolone Acetonide Aqueous Nasal Spray 110 μg and 220 μg Once Daily on Basal Hypothalamic-Pituitary-Adrenal (HPA) Axis Function in Children [>=2 to < 12 Years of Age] With Allergic Rhinitis (AR).
The primary objective was to evaluate the effect of a 6-week treatment with TAA-AQ (110 μg) and TAA-AQ (220 μg) once daily (QD) versus placebo on hypothalamic-pituitary-adrenal (HPA) axis function as measured by serum cortisol AUC(0-24 hr) in children (>=2 to <12 years old) with allergic rhinitis (AR).
The study consisted of a run-in single-blind screening phase (prerandomization) followed by
an approximately 6-week double-blind treatment phase (postrandomization).
Total study duration per participant lasted from 7.5 to 13 weeks and consisted of:
- Screening and single-blind phases (these 2 phases ran concurrently, prerandomization)
for 8 to 24 days. During the screening phase participants were given a single-blind
placebo nasal spray to enable them to practice their intranasal application technique
once daily in the morning (1 actuation/nostril).
- Randomization to the double-blind treatment phase. Treatment assignment was randomized
with stratification by sex and age group (>=2 to <6, >=6 to <12 years old).
- Double-blind treatment phase which lasted at least 42 days and ran up to 47 days.
Participants were administered either TAA-AQ nasal spray or placebo nasal spray.
- An evaluation at the end of treatment 1-3 days after completion of the double-blind
phase.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment