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Fexofenadine Provides Consistent Relief in Paediatric Seasonal Rhinitis : Presented at AAAAI

By Jill Stein

DENVER, CO -- March 9, 2003 -- Fexofenadine effectively relieves all symptoms of seasonal allergic rhinitis (SAR) in children aged 6 through 11, according to data presented here March 8^th at the 60^th Annual Meeting of the American Academy of Allergy, Asthma and Immunology.

Dr. Ulrich Wahn, with University Children's Hospital in Berlin, described results in 935 children who had been randomised to 2 weeks' treatment with fexofenadine 30 mg BID or placebo, with no dosing instructions regarding food intake, conducted at 148 centers in 15 countries.

For inclusion in the study, children were required to have an approximate 1-year history of SAR. They also had a positive skin prick test to at least one allergen indigenous to the study site area or, when relevant, to a child's site of residence, which must have been positive in serum allergen-specific immunoglobulin E testing. In addition, the appropriate sensitising allergen was required to be present at the first visit and likely to be present for 3 weeks after the first visit.

Individual symptoms were evaluated at baseline and again at 7 pm during double-blind treatment. Symptoms included including sneezing, rhinorrhoea, and itchy nose, mouth, throat and/or ears, itchy, watery and red eyes; and nasal congestion.

Results showed that fexofenadine 30 mg BID, significantly improved all symptoms compared with placebo -- sneezing (p=0.0001), rhinorrhoea (p=0.0005), itchy nose, mouth, throat and/or ears (p=0.0001) itchy, watery, red eyes (p=0.0001), and nasal congestion (p=0.0079).

Daily analysis of the symptoms showed that the improvement with fexofenadine was overall statistically significant compared with placebo for the treatment period (p < 0.05).

Significant improvement to symptoms of sneezing, and itchy nose, mouth, throat and/or ears, and itchy, watery, red eyes, occurred for each day of the 14-day treatment period.

A total of 935 children received at least one dose of the double-blind treatment and were therefore included in the safety analysis. The frequency of treatment-emergent adverse events was similar between the fexofenadine (85/464, 18.3%) and placebo (88/471, 18.7%). The number of treatment-emergent adverse possibly related to treatment was also comparable between treatment groups (14/464 for fexofenadine; 11/471 placebo).

Dr. Wahn said that the results of the trial demonstrate the significant and sustained efficacy of fexofenadine 30 mg BID, administered for 14 days to children 6 to 11 years of age.

The study was sponsored by Aventis Pharma.

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