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

doi:10.1186/1471-2296-9-59

BMC Family Practice

Volume 9

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de Bot CM
Moed H
Berger MY
Röder E
de Groot H
de Jongste JC
van Wijk RG
Wouden JC

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Moed H
Berger MY
Röder E
de Groot H
de Jongste JC
van Wijk RG
Wouden JC
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Study protocol

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

Cindy MA de Bot¹ , Heleen Moed¹ , Marjolein Y Berger¹ , Esther Röder¹^,2 , Hans de Groot² , Johan C de Jongste³ , Roy Gerth van Wijk² and Johannes C van der Wouden¹

¹Department of General Practice, Erasmus MC-University Medical Center Rotterdam, PO Box 2040, 3000 CA Rotterdam, the Netherlands

²Department of Allergology, Erasmus MC-University Medical Center Rotterdam, PO Box 2040, 3000 CA Rotterdam, the Netherlands

³Department of Pediatric Respiratory Medicine, Erasmus MC-University Medical Center/Sophia Children's Hospital, Rotterdam, PO Box 2040, 3000 CA Rotterdam, the Netherlands

author email corresponding author email

BMC Family Practice 2008, 9:59doi:10.1186/1471-2296-9-59


Published:	20 October 2008

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.

Methods

Recruitment 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.

Results

A 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.

Conclusion

Our 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 registration

the trial is registered as ISRCTN91141483 (Dutch Trial Register)