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

tuffiness, discharge and sneezing.

Every morning, caregivers were asked to rate his/her child's symptoms of sneezing and nasal stuffiness, discharge and itching over the last 24 hours. Patients' symptoms were also rated at the time immediately before receiving their daily medication.

Over four weeks, patients treated with Nasacort AQ showed a reduction from baseline in the mean adjusted sum of symptoms including sneezing, nasal stuffiness, discharge and itching (Total Nasal Symptom Score or TNSS) measured over the last 24 hours (reflective TNSS) and immediately prior to dosing (instantaneous TNSS). Instantaneous TNSS was the primary end point and showed a greater reduction from baseline of -2.28 +/- 0.16 and -1.92 +/- 0.16 in the Nasacort AQ and placebo groups respectively trending in favor of Nasacort AQ (p value 0.095). Reflective TNSS showed a statistically significantly greater reduction from baseline in the Nasacort AQ group -2.31 +/- 0.15 vs. placebo - 1.87 +/- 0.15 (p value 0.0328). The rates of the treatment-emergent adverse events (TEAEs) among patents treated with Nasacort were comparable to those given placebo (50.8% and 48.3% respectively). The most common TEAEs observed during the double-blind portion of the trial included cough (7.6% vs 9.2%), pyrexia (6.8% vs 8.0%), and headache (5.5% vs 4.2%) in the Nasacort AQ vs placebo groups respectively. No serious side effects were reported in either group. There were no clinically meaningful changes in any of the vital signs analyzed.

About Allergic Rhinitis

Allergic rhinitis is an allergic condition usually accompanied by sneezing, watery nasal discharge and itching of the nose and eyes. Caused by an allergic reaction to allergens such as house dust mites, animal dander, tree or grass pollen, allergic rhinitis is the most common chronic childhood disease, effecting as many as 40% of all children in the U.S. On any given day, 10,000 American children miss school because of allergic
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SOURCE sanofi-aventis
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