SUBLINGUAL IMMUNOTHERAPY FOR PEANUT ALLERGY

花生过敏的舌下免疫治疗

• 批准号: 7953722
• 负责人: SCOTT H SICHERER
• 金额: $ 0.81万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7953722
• 关键词: Allergic; Allergy to peanuts; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Development; Dose; Double-Blind Method; Food; Funding; Grant; Immunologics; Incidence; Individual; Ingestion; Institution; Maintenance; Measures; Oral; Peanuts - dietary; Placebo Control; Proteins; Randomized; Research; Research Personnel; Resources; Safety; Serious Adverse Event; Source; Staging; Sublingual drug administration; United States National Institutes of Health; desensitization; sublingual immunotherapy

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. 1/29/2008 This is a multi-center, 1:1 randomized, double-blind, placebo-controlled, through the 5 gm Oral Food Challenge (OFC) at week 44, trial to investigate the safety and immunologic effects of daily peanut sublingual immunotherapy (SLIT) for peanut allergy. The primary objective is to determine in subjects with peanut allergy whether daily sublingual administration of peanut protein induces increased peanut desensitization as measured by OFCs after 44 weeks of therapy and after a total maintenance SLIT therapy of approximately 1, 2, and 3 years. The secondary objectives are as follows: 1.) To determine the percentage of subjects who tolerate the buildup stage to 2100 mcg/day of peanut SLIT. 2.) To determine if "higher-dose" peanut SLIT (3500 mcg daily maintenance of peanut protein), compared to the initial dose peanut SLIT (2100 mcg daily maintenance of peanut protein), results in the development of differences in desensitization to peanut as determined by OFC. 3.) To determine if, after approximately 36 months of maintenance peanut SLIT, the peanut desensitization and changes in immunologic parameters are sustainable ["tolerance" induction] once daily therapy is discontinued for 8 weeks and functional tolerance occurs. 4.) To characterize the safety of peanut SLIT by determining the incidence of all serious adverse events throughout the duration of the study. Hypothesis: Daily ingestion of small amounts of peanut protein will desensitize peanut-allergic individuals (increasing their ability to ingest peanut while on therapy) and after long term treatment will induce tolerance to peanut (a permanent ability to ingest peanut while off therapy).

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 2008年1月29日 这是一个多中心，1：1随机，双盲，安慰剂对照，在第44周的5克口服挑战（OFC）试验中，研究了每日花生舌下舌下免疫疗法（SLIT）对花生过敏的安全性和免疫学影响。主要目的是确定花生过敏的受试者，是否每天舌下舌下给药花生蛋白会诱导花生脱敏的增加，如在治疗44周后通过OFC所测量的，以及在总维持狭缝疗法约为1、2和3年之后。 次要目标如下： 1.）确定耐受堆积阶段的受试者的百分比为2100 mcg/天花生缝。 2.）与初始剂量的花生裂相比，要确定“高剂量”花生裂（3500 MCG每天维持花生蛋白）（2100 mcg每天维持花生蛋白），从而导致脱敏对花生的差异的发展，该差异是由OFC确定的。 3.）确定在维持花生缝的大约36个月后，一旦每天停用了8周，并且发生功能耐受性，花生脱敏和免疫学参数的变化是可持续的[“耐受性”诱导的。 4.）在整个研究期间，确定所有严重不良事件的发生率，以表征花生裂缝的安全性。 假设： 每天摄入少量的花生蛋白会使花生过敏的个体脱敏（增强他们在治疗期间摄入花生的能力），长期治疗后，将诱发对花生的耐受性（永久性地摄取花生的能力，同时摄取花生的治疗时）。