Suomen Terveystalo Allergy Clinic, Turku, Finland.
Clin Ther. 2011 Oct;33(10):1537-46. doi: 10.1016/j.clinthera.2011.09.013. Epub 2011 Oct 13.
Allergic rhinoconjunctivitis is a risk factor for asthma development. Treating the underlying allergy may represent an attractive method of asthma prevention. No regulatory guidance exists in this area, and, to our knowledge, no clinical investigations meeting modern regulatory standards have been published.
The objective of this publication is to describe the rationale behind the design of and report on the recruitment for the ongoing pediatric Grazax Asthma Prevention (GAP) trial.
The trial was designed for assessment of the preventive effect of an SQ-standardized grass allergy immunotherapy tablet (AIT) on asthma development, both during treatment and after the end of treatment. (The standardized quality [SQ] procedure is a standardization procedure comprising 3 components: total potency, major allergen content, and assessment of extract complexity.) The trial design was discussed with several European Competent Authorities.
The GAP trial is a multinational, parallel-group, double-blind, placebo-controlled randomized trial. Main eligibility criteria were age of 5 to 12 years, grass pollen-induced allergic rhinoconjunctivitis, no asthma, and no overlapping symptomatic allergies. The children have been randomized 1:1 to receive the grass AIT or placebo once daily for 3 years, followed by a blinded observational period of 2 years. Asthma is assessed by the investigators according to specific diagnostic criteria, used at screening visits before randomization to exclude children with existing asthma, and evaluated at least half-yearly during the trial. Seven months of screening resulted in 812 randomized children at 101 centers in 11 countries.
To our knowledge, the GAP trial represents the first double-blind, placebo-controlled randomized trial to assess the preventive effect of allergen-specific immunotherapy on asthma development. A total of 812 children were successfully recruited into the trial. EudraCT number: 2009-011235-12.
过敏性鼻结膜炎是哮喘发展的一个风险因素。治疗潜在的过敏可能是预防哮喘的一种有吸引力的方法。在这一领域没有监管指导，据我们所知，没有符合现代监管标准的临床研究发表。
本出版物的目的是描述正在进行的儿童 Grazax 哮喘预防 (GAP) 试验设计背后的原理，并报告其招募情况。
该试验旨在评估一种 SQ 标准化草过敏免疫治疗片剂 (AIT) 在治疗期间和治疗结束后的预防哮喘发展的效果。(标准化质量 [SQ] 程序是一个包含 3 个部分的标准化程序：总效价、主要过敏原含量和提取物复杂性评估。)该试验设计与几个欧洲主管当局进行了讨论。
GAP 试验是一项多中心、平行组、双盲、安慰剂对照随机试验。主要入选标准为年龄 5 至 12 岁、草花粉诱导的过敏性鼻结膜炎、无哮喘和无重叠症状性过敏。儿童被随机 1:1 分为接受草 AIT 或安慰剂，每天一次，持续 3 年，然后进行 2 年的盲法观察期。哮喘由研究者根据特定的诊断标准进行评估，在随机分组前的筛查访视中使用，以排除已有哮喘的儿童，并在试验期间至少每半年评估一次。7 个月的筛选在 11 个国家的 101 个中心纳入了 812 名随机儿童。
据我们所知，GAP 试验是第一项评估过敏原特异性免疫治疗预防哮喘发展的双盲、安慰剂对照随机试验。共有 812 名儿童成功入选该试验。EudraCT 编号：2009-011235-12。
