Randomized double-blind placebo-controlled trial of sublingual immunotherapy in children with house dust mite allergy in primary care: study design and recruitmentReportar como inadecuado




Randomized double-blind placebo-controlled trial of sublingual immunotherapy in children with house dust mite allergy in primary care: study design and recruitment - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

BMC Family Practice

, 9:59

First Online: 20 October 2008Received: 21 April 2008Accepted: 20 October 2008

Abstract

BackgroundFor respiratory allergic disorders in children, sublingual immunotherapy has been developed as an alternative to subcutaneous immunotherapy. Sublingual immunotherapy is more convenient, has a good safety profile and might be an attractive option for use in primary care. A randomized double-blind placebo-controlled study was designed to establish the efficacy of sublingual immunotherapy with house dust mite allergen compared to placebo treatment in 6 to18-year-old children with allergic rhinitis and a proven house dust mite allergy in primary care. Described here are the methodology, recruitment phases, and main characteristics of the recruited children.

MethodsRecruitment took place in September to December of 2005 and 2006. General practitioners in south-west Netherlands selected children who had ever been diagnosed with allergic rhinitis. Children and parents could respond to a postal invitation. Children who responded positively were screened by telephone using a nasal symptom score. After this screening, an inclusion visit took place during which a blood sample was taken for the RAST test.

ResultsA total of 226 general practitioners invited almost 6000 children: of these, 51% was male and 40% <12 years of age. The target sample size was 256 children; 251 patients were finally included. The most frequent reasons given for not participating were: absence or mildness of symptoms, absence of house dust mite allergy, and being allergic to grass pollen or tree pollen only. Asthma symptoms were reported by 37% of the children. Of the enrolled children, 71% was sensitized to both house dust mite and grass pollen. Roughly similar proportions of children were diagnosed as being sensitized to one, two, three or four common inhalant allergens.

ConclusionOur study was designed in accordance with recent recommendations for research on establishing the efficacy of sublingual immunotherapy; 98% of the target sample size was achieved. This study is expected to provide useful information on sublingual immunotherapy with house dust mite allergen in primary care. The results on efficacy and safety are expected to be available by 2010.

Trial registrationthe trial is registered as ISRCTN91141483 Dutch Trial Register

Electronic supplementary materialThe online version of this article doi:10.1186-1471-2296-9-59 contains supplementary material, which is available to authorized users.

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Autor: Cindy MA de Bot - Heleen Moed - Marjolein Y Berger - Esther Röder - Hans de Groot - Johan C de Jongste - Roy Gerth van

Fuente: https://link.springer.com/







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