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

Abstract

Background: For 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.

Sublingual immunotherapy not effective in house dust mite–allergic children in primary care

“…A detailed description of the sample size calculation of the study has been published elsewhere (28). We aimed at a sample size of 128 patients in each study group, allowing for 25% loss to follow-up.…”

“…The study was approved by the Ethical Review Board of Erasmus MC. A detailed description of the design of the study has been published elsewhere and is summarized below (28). The trial was registered as ISRCTN91141483 (Dutch Trial Register).…”

Challenges in the implementation of the EAACI AIT guidelines: A situational analysis of current provision of allergen immunotherapy

“…Barriers carried out in primary care, demonstrating proof of concept. 56,57 It is of further interest that in a real-life study of AIT adherence carried out in the Netherlands that adherence and persistence was higher amongst patients of GPs than those of allergists or other specialists. 58 The development of pathways of care should facilitate the delivery of high-quality effective services and improve patient selection.…”

Evaluation of Clinical and Immunological Responses: A 2-Year Follow-Up Study in Children with Allergic Rhinitis due to House Dust Mite

“…This study is a part of the randomized placebo-controlled trial ISRCTN91141483 which evaluates sublingual immunotherapy with low-dose house dust mite allergen (2.03 mcg/mL or 700 BU/mL Der p1) in children with AR [15, 16]. Patients entered the study either in September–December 2005 or in September–December 2006 for a period of approximately two years.…”