Cypress, CA – West Coast Clinical Trials, LLC just completed a clinical trial that tested the effect of a 6 week treatment with triamcinolone acetonide aqueous nasal spray vs. placebo on basal hypothalamic-pituitary-adrenal (HPA) axis function in children 2-11 years of age with Allergic Rhinitis.
This was a phase IV study to characterize the effect of TAA-AQ 110 µg once daily on basal HPA axis function in children. Methods: This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study.
Main inclusion criteria were age ≥2 to 11 years, documented diagnosis of seasonal or perennial allergic rhinitis by history and positive skin prick test, with ≥1 nasal symptom (nasal pruritus, sneezing rhinorrhea, or congestion) rated ≥1 on a 0-3 scale, and a morning serum cortisol within 5 – 22 µg/dL at Visit 1. Protocol approval was obtained from Schulman Associates IRB. Written informed consents were obtained from parents/legal guardians and assent from the participants. Following a brief single-blind placebo run-in period, subjects were randomized by age group and sex strata to receive TAA-AQ (55 µg of TAA/spray) 1 spray/nostril (children ≥2 to 11 years of age) or 2 sprays/nostril (children ≥6 to 11 years of age) or matching placebo for 42 to 47 days. Subjects underwent 2 domiciled visits to assess 24hr serum cortisol pre- and post- treatment, and recorded daily nasal symptom scores.
WCCT is a privately owned early phase development contract research organization, conveniently located near 3 major airports in Southern California. WCCT was founded by Dr. Kenneth Kim who is board certified in Internal Medicine and Allergy and Immunology. Conducting trials since 1998, WCCT has been audited by the FDA and numerous pharmaceutical and biotechnology companies. WCCT’s location and access to an ethnically diverse population allows for a wide variety of study designs including ethnic bridging. With 150 beds in two locations and over 60,000 square feet, a well-trained and experienced staff, and advanced technological procedures, WCCT brings the highest quality to the pharmaceutical and biotechnology industries. (www.wcct.com)
West Coast Clinical Trials, LLC
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