Background

Allergic sensitization to environmental allergens in the first years of life is a strong predictor of asthma morbidity in children. Allergy immunotherapy can improve asthma and allergy outcomes, but its efficacy in inner-city, atopic children of less than 4 years of age with recurrent wheezing has not yet been established.

Objective

To determine whether subcutaneous allergy immunotherapy improves asthma in a population of US inner-city children when started at less than 4 years of age.

Methods

In a randomized controlled, open-label phase I-II single-center trial in the Bronx, New York, 58 children with recurrent wheezing or physician-diagnosed asthma were randomized to receive asthma standard of care treatment with or without a 3-year course of multiple allergen subcutaneous immunotherapy.

Results

A total of 23 children in the control group and 27 children in the immunotherapy group began the study. A total of 20 of 27 children commencing immunotherapy completed at least 2 years of immunotherapy. There was no difference in asthma medication and symptom scores between the treatment or control groups over time. Similarly, naso-ocular symptoms and allergy medication use were similar in both groups over time. Nevertheless, asthma-related quality of life improved in the immunotherapy group compared with the control group (P = .03).

Conclusion

With the exception of asthma-related quality of life, allergy immunotherapy was ineffective in improving asthma outcomes in this population of inner-city children of less than 4 years of age. These findings suggest that the effects of allergy immunotherapy depend on population-specific factors and highlight the importance of precise predictors of immunotherapy efficacy.

Trial Registration

ClinicalTrials.gov Identifier: NCT01028560.

中文翻译：

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内城4岁以下哮喘儿童皮下过敏免疫治疗的随机试验

背景

出生后最初几年对环境过敏原的过敏反应是儿童哮喘发病率的有力预测因素。过敏免疫疗法可以改善哮喘和过敏结局，但其对内城、4 岁以下反复喘息的特应性儿童的疗效尚未确定。

客观的

旨在确定皮下过敏免疫疗法是否能改善美国市中心儿童在 4 岁以下开始的哮喘。

方法

在纽约布朗克斯的一项随机对照、开放标签 I-II 期单中心试验中，58 名反复喘息或医生诊断为哮喘的儿童随机接受哮喘标准治疗，有或没有 3 年疗程多种过敏原皮下免疫治疗。

结果

对照组共有 23 名儿童和免疫治疗组的 27 名儿童开始研究。在开始免疫治疗的 27 名儿童中，共有 20 名完成了至少 2 年的免疫治疗。随着时间的推移，治疗组或对照组之间的哮喘药物治疗和症状评分没有差异。同样，随着时间的推移，两组的鼻眼症状和过敏药物的使用情况相似。尽管如此，与对照组相比，免疫治疗组的哮喘相关生活质量有所改善（P = .03）。

结论

除了与哮喘相关的生活质量外，过敏免疫疗法在改善这一 4 岁以下市中心儿童人群的哮喘结果方面无效。这些发现表明，过敏免疫疗法的效果取决于特定人群的因素，并突出了免疫疗法疗效精确预测因素的重要性。

试用注册

ClinicalTrials.gov 标识符：NCT01028560。