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Study Confirms Fexofenadine Safe and Effective for Children with Seasonal Allergic Rhinitis: Presented at AAAAI
By Bonnie Darves
SAN FRANCISCO, CA -- March 26, 2004 -- Fexofenadine (Allegra) is safe and effective for treating seasonal allergic rhinitis in children ages 6 to 11 years, researchers reported here March 22nd at the American Academy of Allergy, Asthma & Immunology 60th Annual Meeting.
Lead U.S. investigator David I. Bernstein, MD, Division of Allergy and Immunology, University of Cincinnati College of Medicine, Cincinnati, Ohio, United States, said that parallel trials with identical protocols were conducted to compare fexofenadine 30 mg BID or placebo given for 2 weeks in children with seasonal allergic rhinitis in the U.S., South America and Europe.
In the U.S., researchers enrolled 247 children, ages 6 to 11 years. The researchers evaluated efficacy as the overall mean change from baseline in 12-hour total symptom score. For admission, each patient was required to show a positive skin prick test to at least one pollen allergen for the current season and concordance for that specific allergen with in vitro testing of immunoglobulin E (IgE). Specific IgE was determined with a fluoroimmunoassay, with positivity defined as IgE class 2 (>0.7 kUA/L). Data analysis was performed on the modified intention-to-treat population.
Patients in both treatment arms showed a similar distribution of pollen allergies -- grass pollen, 44% in fexofenadine and 43.8% in placebo; weed pollen, 48.8% and 47.9%, respectively, and tree pollen, 35.4% and 35.5%, respectively. The distribution of positive tests for specific IgE in these patients was 39% for grass pollen, 38% for weed pollen and 23% for tree pollen.
Each patient's symptoms were assessed twice daily with the total symptom score at 7 a.m. and 6 p.m., immediately before taking the medication.
At the end of the 2-week study, patients taking fexofenadine had a highly significant improvement in symptoms of seasonal allergic rhinitis, compared to patients on placebo (P = .0002).
The drug was well tolerated, with adverse events being rare and minor in nature. Findings of this controlled study confirm the safety and efficacy of fexofenadine in children with seasonal allergic rhinitis, Dr. Bernstein concluded.
[Study title: Fexofenadine effectively relieves seasonal allergic rhinitis in children from the USA. Poster 828]
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