drugset / Trial / NCT01154153

Nasacort AQ Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Children With Allergic Rhinitis

NCT01154153

Phase 4 Completed 140 enrolled Sanofi
RandomizedParallel-groupTriple-blindTreatment

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).

Timeline

Start
2010-06
Primary completion
2010-10
Completion
2010-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Triamcinolone Acetonide Other / unclassified 110 ug Intranasal
Subject Triamcinolone Acetonide Other / unclassified 220 ug Intranasal
Background Loratadine Small molecule 5 mg Oral

Indications