Abstract

The safety and efficacy of specific immunotherapy for mold allergy are not known in children and adolescents. We evaluated the efficacy and safety of specific immunotherapy with a standardized allergen extract in a randomized, double-blind, placebo-controlled, 3-year prospective study of patients who were allergic to only Alternaria alternata. Fifty children and adolescents (25 girls; 5-18 years of age) with A alternata-induced seasonal allergic rhinoconjunctivitis and/or bronchial asthma were randomly assigned to groups given treatment (Novo-Helisen Depot, A alternata 100%) or placebo. The primary end point was the combined symptom medication score. Secondary end points included safety, quality of life, and sensitivity to allergen-specific nasal challenge. Forty-five children completed the 3-year study. Although there was no significant change in year 1, the combined symptom medication score decreased in years 2 and 3 of the study (by 38.7% and 63.5%, respectively; P < .001 for each). The reduction in symptoms was associated with a significant improvement in quality of life (P < .05) and decrease in sensitivity after allergen-specific nasal challenge. Side effects were observed in 7 patients; the most common (edema at the site of injection) occurred after 11 injections. Allergen-specific immunotherapy with standardized A alternata extract reduces symptoms of asthma and rhinoconjunctivitis in children and adolescents without serious side effects.

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