Continuous Use Nasacort AQ Nasal Spray Had No Treatment Effect On Stature-for Age Distribution Among 2-5 Year-olds With Year-round Allergic Rhinitis

Main Category: Allergy
Also Included In: Ear, Nose and Throat;  Clinical Trials / Drug Trials;  Pediatrics / Children's Health
Article Date: 17 Mar 2008 - 1:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Data presented at the annual meeting of the American Academy of Allergy Asthma & Immunology (AAAAI) suggests that the continuous use of intranasal corticosteroid Nasacort AQ (triamcinolone acetonide) Nasal Spray had no treatment effect on stature-for age distribution among children aged 2-5 years old with year-round allergic rhinitis.

"Continuous use of intranasal corticosteroids in the treatment of very young children with allergic rhinitis has in the past raised concerns regarding potential effects on growth," said study investigator Dr. Paul Ratner, Medical Director, Sylvana Research Associates, San Antonio, Texas. "I am encouraged by the results which showed that following 6 month treatment with Nasacort AQ, the stature-for-age distribution did not appear to shift compared to pretreatment in children aged 2-5 years who suffer from year-round allergies."

This is one of the first controlled studies in the U.S. designed to investigate both the efficacy and safety of intranasal corticosteroid treatment in children aged 2-5 years with year-round allergies. The trial included a four-week, multicenter, double-blind treatment period during which 433 children were randomized to receive either Nasacort AQ 110 µg or placebo as 1 spray per nostril once daily. After four weeks, 353 patients entered into a 6-month open label phase receiving treatment with once-daily Nasacort AQ. Height was measured at Visit 1 to establish a baseline, Visit 4 after the initial 4 weeks, and Visit 8 when the 6-month open label period completed. The treatment-emergent adverse event profile was similar between the Nasacort AQ group and placebo group, and consistent with the profile in children 6 years of age and older. To participate in the study, patients had to have year-round allergic rhinitis.

Height was measured at each office visit using a stadiometer, an instrument for measuring height. After the four-week double-blind period, no treatment effect was seen in adjusted mean height increase SE (p=0.4086) between children treated with Nasacort AQ (0.62 0.224 cm; n=217) and those receiving placebo (0.38 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 and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT : SAN) and in New York (NYSE : SNY). http://en.sanofi-aventis.com/index.asp

Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2007. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.