Michaud Elodie, Evrard Bertrand, Pereira Bruno, Rochette Emmanuelle, Bernard Lise, Rouzaire Paul-Olivier, Gourdon-Dubois Nelly, Merlin Etienne, Fauquert Jean-Luc
CHU Clermont-Ferrand, Pole pédiatrique, Unité d'allergologie de l'enfant, CHU Estaing, 1 Place Lucie et Raymond Aubrac, F-63003, Clermont-Ferrand, France.
CHU Clermont-Ferrand, Département d'immunobiologie, CHU Estaing, 1 Place Lucie et Raymond Aubrac, F-63003, Clermont-Ferrand, France.
Trials. 2015 Apr 29;16:197. doi: 10.1186/s13063-015-0717-y.
Peanut allergy is an increasingly common health problem. Current treatment guidelines are based on strict avoidance. However, in the last few years, oral immunotherapy protocols have shown promising results yielding increased tolerance to peanut in allergic children. Adolescence is particularly at risk.
METHODS/DESIGN: We have designed a randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of peanut oral escalating immunotherapy in a 12- to 18-year-old population with proved allergy to peanut. Patients are selected when the threshold of peanut intake is over 100 mg and 2 cumulated g on the first double-blind, placebo-controlled oral food challenge (DBPCOFC). During the build-up placebo-controlled blinded phase, doses containing peanut or placebo will be administered by gradual up-dosing from 10 mg to 2 g with 2-weekly increments. After this first randomized phase, the desensitized participants will continue to intake native peanut in an unblinded process during 13 or 37 weeks following a second randomization. Adverse events are picked up and managed throughout the entire protocol. The main endpoint is the percentage of patients with negative DBPCOFC at the threshold of 2 g of cumulative peanut at the end of the build-up phase of 24 weeks. Secondary endpoints include: (1) desensitization 6 weeks and 6 months after the end of the maintenance phase; (2) adverse effects during the build-up phase; (3) immunological profile confirming peanut desensitization. Immunologic assays will be carried out at every DBPCOFC and at the middle of the build-up phase to evaluate the peanut immunologic profile modifications.
This double-blind, placebo-controlled study will be, to our knowledge, the first evaluation of a peanut oral immunotherapy protocol in teenagers in the purpose to reduce severe reactions after unexpected intake and to improve quality of life.
ClinicalTrial.gov: NCT02046083 (23 January 2014).
花生过敏是一个日益常见的健康问题。当前的治疗指南基于严格避免接触。然而，在过去几年中，口服免疫疗法方案已显示出有前景的结果，使过敏儿童对花生的耐受性增加。青少年尤其处于风险之中。
方法/设计：我们设计了一项随机、双盲、安慰剂对照、多中心研究，以调查花生口服递增免疫疗法在12至18岁已证实对花生过敏人群中的疗效和安全性。当在首次双盲、安慰剂对照口服食物激发试验（DBPCOFC）中花生摄入量阈值超过100毫克且累积量达到2克时，选择患者。在累积安慰剂对照盲法阶段，含花生或安慰剂的剂量将以每周递增的方式从10毫克逐渐增加至2克，每两周增加一次。在这个第一个随机阶段之后，脱敏的参与者将在第二次随机分组后的13或37周内，在非盲法过程中继续摄入天然花生。在整个方案过程中收集并处理不良事件。主要终点是在24周的累积阶段结束时，累积花生量达到2克阈值时DBPCOFC为阴性的患者百分比。次要终点包括：（1）维持阶段结束后6周和6个月的脱敏情况；（2）累积阶段的不良反应；（3）确认花生脱敏的免疫学特征。在每次DBPCOFC以及累积阶段中期进行免疫测定，以评估花生免疫学特征的改变。
据我们所知，这项双盲、安慰剂对照研究将是首次对青少年花生口服免疫疗法方案进行评估，目的是减少意外摄入后的严重反应并改善生活质量。
ClinicalTrial.gov：NCT02046083（2014年1月23日）。
