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FDA Approves Nasacort AQ(R) Nasal Spray for Children Aged 2-5 years old
Date:9/23/2008

Randomized, double-blind, placebo-controlled study conducted in the U.S. demonstrated both the efficacy and safety of Nasacort AQ(R) in children

with nasal symptoms associated with perennial allergic rhinitis

BRIDGEWATER, N.J., Sept. 23 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today the U.S. Food and Drug Administration (FDA) has approved Nasacort AQ Nasal Spray (triamcinolone acetonide) for children aged 2-5 years old for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis.

The FDA based its approval on the results of a multicenter, randomized, double-blind, placebo-controlled study demonstrating that Nasacort AQ can be used safely and effectively to treat nasal symptoms of year-round allergies in children between two and five years. This is the first and largest placebo- controlled trial designed to specifically investigate both the efficacy and safety of an intranasal corticosteroid vs. placebo in 2-5 years of age group.

"We welcome this new treatment option for our very young patients," said lead investigator Dr. Steven Weinstein, Director, Allergy and Asthma Specialist Medical Group in Huntington Beach, California. "Nasacort AQ Nasal Spray has been proven effective for the age groups two to five years to relieve nasal allergy symptoms."

Approval Based on Pediatric Clinical Trial

The study showed that Nasacort AQ, given as 1 spray/nostril once daily for four weeks to children aged 2-5 years, with year-round allergic rhinitis diagnosed for at least one year, significantly improved the combined symptoms of sneezing, itching, runny nose and congestion, compared with placebo.

A total of 464 patients were randomized and received either Nasacort AQ or placebo as 1 spray per nostril once daily for 4 weeks. To participate in the study, patients had to have year-round allergic rhinitis diagnosed for at least one year and reported sufficiently severe symptoms of nasal s
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SOURCE sanofi-aventis
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