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New Trial Presented at AAAAI Reports that the Growth of Children 2-5 Years Old with Year-Round Allergic Rhinitis Continued According to Normal Age-Adjusted Distribution Over a 6-Month Treatment with Nasacort AQ
Date:3/15/2008

week double-blind period, no treatment effect was seen in adjusted mean height increase plus or minus SE (p=0.4086) between children treated with Nasacort AQ (0.62 plus or minus 0.224 cm; n=217) and those receiving placebo (0.38 plus or minus 0.225 cm; n=216). After the 6-month open label period (Visit 8), the adjusted mean increase in height was 3.62 + 0.693 cm. Based on the Centers for Disease Control and Prevention (CDC) growth standards, the distribution of patients by height-for-age percentile remained constant from Visit 1 to Visit 8. At Visit 1, 6.2% of children were in the <5 percentile (n=22) versus 5.4% (n=19) at Visit 8. Similarly, at Visit 1, 6.5% of children (n=23) were within the >95th percentile versus 7.4% at Visit 8. At both Visit 1 and Visit 8, 87.3% of children (n=308) fell between the 5th and 95th percentile.

The study was submitted as part of a supplemental New Drug Application (sNDA) for Nasacort AQ in children aged 2 - 5 years, which was recently accepted for review by the FDA.

About CDC Growth Charts

The CDC growth charts consist of a series of percentile curves that illustrate the distribution of selected body measurements in U.S. children. The charts provide health professionals with a tool to compare growth in infants, children, and adolescents with a nationally representative reference based on children of all ages and racial or ethnic groups. The CDC growth charts were updated in 2000.

About Allergic Rhinitis

Allergic rhinitis is a swelling of the nasal passages, usually accompanied by sneezing, watery nasal discharge and itching of the nose and eyes. This medical condition is caused by an allergic reaction to allergens such as house dust, animal dander, or pollen. On any given day, 10,000 American children miss school because of allergic rhinitis, for a total of 2 million lost school days.

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops an
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