The U.S. Food and Drug Administration (FDA) has approved triamcinolone acetonide (Nasacort™) nasal spray for children aged 2-5 years for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis.

The approval is based on the results of a multicentre, randomised, double-blind trial in which 464 children with year-round allergic rhinitis diagnosed for at least one year were randomised to triamcinolone or placebo nasal spray (one spray per nostril once daily for 4 weeks). The primary endpoint was instantaneous Total Nasal Symptom Score (TNNS), the reduction from baseline in the mean adjusted sum of symptoms including sneezing, nasal stuffiness, discharge and itching measured immediately prior to dosing.

The results demonstrated a reduction from baseline of -2.28 +/- 0.16 and -1.92 +/- 0.16 in the treatment arm and placebo arm, respectively, (p = 0.095).

Editors note: Triamcinolone (Nasocort™) nasal spray is not currently licensed for use in children under the age of six years in the UK