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Long-Term Use of Steroid Nasal Spray Does Not Slow Growth of Young Children: Presented at AAAAI

By Em Brown

PHILADELPHIA -- March 17, 2008 -- Long-term use of the corticosteroid nasal spray triamcinolone acetonide is safe for children as young as 2 years, researchers reported here at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.

After 7 months of treatment, the study found no difference in linear growth between kids on triamcinolone nasal spray and normal growth as determined by the Center for Disease Control and Prevention's standardized growth charts, said principal investigator Paul Ratner, MD, Medical Director, Sylvana Research, and Allergist in private practice, San Antonio, Texas.

The study involved 433 children with perennial allergic rhinitis who were aged 2 to 5 years.

The first phase was a 4-week, placebo-controlled trial of triamcinolone given once a day in a single 110-mcg spray. "Active treatment was significantly better than placebo," Dr. Ratner reported.

In the second phase, 353 of the children in the cohort continued in a 6-month, open-label study of triamcinolone 110 mcg once daily. Growth was measured monthly using a standard stadiometer.

Long-term use of triamcinolone spray did not blunt growth in the children. "The big news is not so much that it works, but that it is safe," Dr. Ratner asserted in his presentation on March 15.

Children grew an average of 3.62 cm during the 7-month growth assessment phase of the study, as was expected according to the CDC growth charts. The percentile distribution remained constant throughout the growth assessment phase of the study, and was similar to the distribution seen on the CDC growth charts.

"Seven months of data is long enough to evaluate need against adverse effects. That's what the FDA uses when they make their decision [for approval]….The company will be applying for expanded labeling to include children as young as 2. If they get it, this will be the first nasal steroid approved for use below age 3," Dr. Ratner commented.

"This is the first time it has been shown that corticosteroids can be given safely in children with perennial allergic rhinitis as young as age 2," he noted. "Nasal steroids in children younger than 2 are not as useful as in older children."


[Presentation title: The Effect on Growth of 6 Month's Treatment With Triamcinolone Acetonide Aqueous Nasal Spray 110 mcg Once Daily in Children Aged 2-5 Years With Perennial Allergic Rhinitis. Poster 216]

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