Navigation Links
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

BRIDGEWATER, N.J., March 15 /PRNewswire-FirstCall/ -- 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 micrograms 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 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 and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

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.

Contact: Amy Ba, sanofi-aventis, (908) 981-6563 or at Amy.Ba@sanofi-aventis


'/>"/>
SOURCE sanofi-aventis
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Raven Announces Initiation of a RAV12 Phase 2 Clinical Trial in Metastatic Pancreatic Cancer
2. Northern California Foot and Ankle Center Santa Rosa Enrolling Patients With Chronic Diabetic Foot Ulcers for Matrix Clinical Research Trial
3. FDA Accepts Investigational New Drug Application for ARI-2243 and a First in Man Clinical Trial Set to Begin During the First Half of 2008
4. Independent Data Safety Monitoring Board Recommends Continuation of Sangarts Pivotal Phase III Trials of Hemospan(R) Following Second Interim Review
5. Nventa Enrolls and Initiates Dosing of Final Cohort in HspE7 Phase 1 Cervical Dysplasia Trial
6. PARI Nebulizer & Compressor Used Exclusively in Inspires Phase 3 CF Trial
7. Keryx Biopharmaceuticals Announces that the SUN-MICRO Phase 3 Clinical Trial Failed to Meet its Primary Efficacy Endpoint
8. JACC Identifies DEFER with 5-year Outcomes as Landmark Trial
9. Multi Merci Trial Results Published in Peer Reviewed Journal
10. Pixantrone to be Studied in Phase I/II Trial for Aggressive Multiple Sclerosis
11. Transgenomic Announces New Contracts for Phase II Trials With Two Major Pharmaceutical Companies
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/4/2016)... ALBANY, N.Y. , Feb. 4, 2016  AMRI (NASDAQ: ... Vice President of Pfizer Inc. and President of Pfizer Global ... effective as of February 4, 2016. In addition, the Company ... member of the audit committee since 2010, has retired from ... time and attention to his other business ventures.  ...
(Date:2/4/2016)... -- --> --> ... Automated External Defibrillator (AED) Market by Product (Semi-Automated External ... Hospitals, Homecare & Nursing Homes) - Forecast to 2019", ... and segments the concerned market with an analysis and ... grow to about $367.0 million by 2019, at a ...
(Date:2/4/2016)... , February 4, 2016 --> ... report "Digital X-ray Market by Application (Mammography, Dental, Chest Imaging, ... System, End User (Diagnostic Center, Hospitals), Price - Global Forecast ... to reach USD 10.46 Billion by 2020 from USD 6.15 ... to 2020. Brow se 270 market data ...
Breaking Medicine Technology:
(Date:2/6/2016)... ... February 06, 2016 , ... ... 5000 PERIOPERATIVE NURSES EXPECTED AT AORN SURGICAL CONFERENCE & EXPO , WHAT: ... world with an estimated 5000 perioperative nurses in attendance to study the ...
(Date:2/6/2016)... ... February 06, 2016 , ... With the FCPX LUT: ... color grades to their footage. A LUT is a Lookup Table that contains a ... corresponding color indicated by the table. By manipulating each pixel, LUT's can change each ...
(Date:2/6/2016)... ... February 06, 2016 , ... Research has shown ... to reduce the frequency and level of relapse. , At the ... and Purpose,” will explore the critical tasks of the recovery phase and beyond ...
(Date:2/5/2016)... , ... February 05, 2016 , ... Love is in ... in a variety of colors, assortments and packaging. This staple for Valentine’s Day is ... Kullen location. , For Valentine’s Day, not only are long-stem roses available, but ...
(Date:2/5/2016)... ... February 05, 2016 , ... Today, the Whole-Food Warrior TV ... the much-anticipated feature with author Jahnavi Foster, specialist in healthy vegetarian cuisine, will stream ... Each week, on his weekly Whole-Food Warrior TV show, Frank Davis highlights Whole-Food Warriors ...
Breaking Medicine News(10 mins):