DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF SUBLINGUAL IMMUNOTHERAPY WITH HOUSE-DUST MITE EXTRACT (DPT) IN CHILDREN

Safety and efficacy of sublingual (sublingual-swallow) immunotherapy ( IT) with house dust mite extract were evaluated in 30 children (6 - 15 (2/3) years of age) over the first 12 months of an ongoing study. The cumulative dose was 570 mu g Der p I (five times that administered wit h subcutaneous therapy). Safety: One patient on active treatment dropp ed out after 8 weeks because of a subjective feeling of severe weaknes s, questionably induced by the therapy. Five patients on active therap y and one patient on placebo reported minor local side effects. Effica cy: Pulmonary symptoms were reduced after 12 months in actively treate d asthmatics, but this was not con consistent with the lack of improve ment in bronchial reactivity, skin sensitivity and specific IgG and Ig G4 against D.pt. in this group. In patients with rhinitis nasal sensit ivity was reduced in the placebo group without concomitant improvement in the nasal symptom score. Specific IgE (D.pt. and D.f.) increased s ignificantly more in the active treatment group after 3 and 12 months. We conclude that sublingual IT over 12 months with the fivefold. Der p 1 dose of subcutaneous IT was well tolerated, but there was no consi stent clinical or immunological benefit compared to placebo.