At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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).
In Brief
A Phase 4 clinical trial evaluating Placebo nasal spray, Triamcinolone acetonide aqueous (TAA-AQ) nasal spray (NASACORT AQ), and 1 other intervention for Rhinitis, Allergic, Perennial and/or Seasonal. Completed, enrolled 140 participants across 8 sites.
Detailed Summary
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).
Study Details
Timeline
Interventions
1 spray/nostril, once daily in the morning, for 8 to 24 days during the screening phase.
Treatment assignment was randomized with stratification by sex and age group (\>=2 to \<6, \>=6 to \<12 years old). * For children who were \>=2 to \<6 years old, 1 spray/nostril (110 µg TAA-AQ), once daily in the morning, for 6 weeks, during the double-blind treatment phase. * For children who were \>=6 yrs to \<12 years old, either 1 spray/nostril (110 µg TAA-AQ) or 2 sprays/nostril (220 µg TAA-AQ), once daily in the morning, for 6 weeks, during the double-blind treatment phase.
Treatment assignment was randomized with stratification by sex and age group (\>=2 to \<6, \>=6 to \<12 years old). * For children who were \>=2 to \<6 years old, 1 spray/nostril, once daily in the morning, for 6 weeks, during the double-blind treatment phase. * For children who were \>= 6 yrs to \<12 years old, either 1 spray/nostril or 2 sprays/nostril, once daily in the morning, for 6 weeks, during the double-blind treatment phase.
Children's Claritin® Syrup \[5 mg of loratadine per 5 mL\] could be taken orally for the relief of AR symptoms throughout the study on an as needed basis, according to the Food and Drug Administration-approved manufacturer's label.