Double-blind, placebo-controlled study of Alternaria alternata immunotherapy: Clinical efficacy and safety

• Published in: Pediatric allergy and immunology Vol. 19; no. 1; pp. 67 - 75
• Main Authors: Tabar, Ana I., Lizaso, María T., García, Blanca E., Gómez, Belen, Echechipía, Susana, Aldunate, María T., Madariaga, Begoña, Martínez, Alberto
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01-02-2008; Blackwell
• Subjects: Adolescent; allergen-specific immunotherapy; Alternaria - immunology; Alternaria alternata; Asthma - physiopathology; Asthma - therapy; Biological and medical sciences; Child; children; clinical efficacy; Desensitization, Immunologic - adverse effects; Double-Blind Method; Female; Fundamental and applied biological sciences. Psychology; Fundamental immunology; Humans; Male; Medical sciences; mold allergy; mold immunotherapy; Peak Expiratory Flow Rate; Rhinitis - physiopathology; Rhinitis - therapy; safety; Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis; Human; Allergy; Immunopathology; Pediatrics; Desensitization; Toxicity; Treatment efficiency; mold allergy; Alternaria alternata; Fungi; Immunology; Treatment; children; Immunotherapy; safety; Placebo; Double blind study; Mould; Fungi Imperfecti; clinical efficacy; Child; mold immunotherapy; allergen-specific immunotherapy
• ISSN: 0905-6157; 1399-3038
• DOI: 10.1111/j.1399-3038.2007.00589.x

Allergen‐specific immunotherapy (ASIT) with fungal extracts has been beset by safety and efficacy problems, which result mainly from qualitative and quantitative variations. Little has been published on the safety and efficacy of these extracts. The objective was to analyze the safety and efficacy of ASIT with an Alternaria alternata extract. A total of 28 patients were selected with rhinitis and/or bronchial asthma because of Alternaria allergy and monosensitization to molds. The patients were randomized to an active ASIT or placebo group, both groups on a conventional immunotherapy schedule (increasing weekly doses until maintenance dose and then monthly doses). Adverse reactions were classified with the European Academy of Allergology and Clinical Immunology system. Clinical efficacy was analyzed for a year with symptom/medication diary cards, peak expiratory flow (PEF) measures, clinical severity score, severity of symptoms (visual analog scale), subjective evaluation of treatment by the patient and the physician, and a quality of life questionnaire. Twenty‐three patients completed the study; all reached the established maintenance dose with only two mild adverse reactions in the whole sample. Significant improvements were found after 6 months in respiratory symptoms in the active treatment group, and in all symptoms in both groups. PEF increased significantly in the active treatment group but not in the placebo group. The severity of asthma decreased in the active treatment group, and the severity of rhinitis decreased in both groups. Visual analog scale scores for severity of symptoms improved in all phases in the active treatment group, but only after 12 months in the placebo group. Physicians judged the disease course as significantly better in the active treatment group. ASIT with the A. alternata extract was safe, with clinical improvements after one year of treatment.