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New Data Presented at ACAAI Informs on the Safety and Efficacy of Nasacort AQ Nasal Spray in a Trial of Children Aged 2-5 Years Old with Year-Round Allergic Rhinitis
Date:11/10/2007

ate in the study, patients had to have year-round allergic rhinitis for at least one year and reported sufficiently severe symptoms of nasal stuffiness, discharge and sneezing. Also, all patients had to demonstrate sensitivity to such allergens in their system as shown by a positive skin prick test.

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

Over four weeks, patients treated with Nasacort AQ showed a statistically significant (P=0.0328) reduction in the combined symptoms of sneezing, nasal stuffiness, discharge and itching (Total Symptom Score or TSS) measured over the last 24 (-2.31 plus or minus 0.15) compared to placebo (-1.87 plus or minus .151). Immediately before receiving the daily treatment, patients treated with Nasacort AQ also reported a numeric, albeit not statistically significant (P= 0.0946), reduction (-2.28 plus or minus 0.16) in TSS compared to placebo (-1.92 plus or minus .16).

Side effects among patients treated with Nasacort AQ were similar to those given placebo and no serious adverse events or clinically meaningful changes in vital signs were reported in either group. Side effects associated with treatment occurred in 50.8% of patients receiving Nasacort AQ and 48.3% of subjects receiving placebo. The most common treatment-related adverse events during the 4-week of treatment with Nasacort AQ and placebo respectively were cough (7.6%, 9.2%), pyrexia (fever) (6.8%, 8%), headache (5.5%, 4.2%), and nasopharyngitis (nose & throat irritation) (5.1%, 3.8%).

In a subset of the same clinical study, Nasacort AQ showed no significant effect on average adrenal function in children aged 2-5 years with year-round allergic rhinitis

Also presented at ACAAI is a report on the effect of Nasacort AQ on
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SOURCE sanofi-aventis
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