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Title: FDA Approves Triamcinolone Acetonide for Allergic Rhinitis in Children Aged 2 to 5 years
URL: http://www.pslgroup.com/dg/22D532.htm
Doctor's Guide
September 23, 2008

NEW YORK -- September 23, 2008 -- The US Food and Drug Administration (FDA) has approved triamcinolone acetonide (Nascort) nasal spray for children aged 2 to 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, placebo-controlled study that included a total of 464 patients who were diagnosed with year-round allergic rhinitis and who reported sufficiently severe symptoms of nasal stuffiness, discharge, and sneezing.

Patients were randomly assigned to receive either triamcinolone acetonide as 1 spray per nostril once daily for 4 weeks or a placebo. Every morning, caregivers were asked to rate his or her child's symptoms over the last 24 hours. Symptoms were also rated at the time immediately before the child received daily medication.

Over 4 weeks, patients treated with triamcinolone acetonide showed a reduction from baseline in the mean of adjusted sum of symptoms, including sneezing, nasal stuffiness, discharge, and itching measured over the last 24 hours.

The most commonly reported adverse events were cough, pyrexia, and headache. No serious side effects were reported.

SOURCE: Sanofi Aventis

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