INNER-CITY ANTI-IGE THERAPY FOR ASTHMA (ICATA)

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 为了评估Xolair与安慰剂相比，在接受标准化的专家护理和基础哮喘教育的市中心患有中到重度过敏性哮喘的儿童和青少年时的疗效。作为一种新的治疗哮喘的新方法，奥马珠单抗作为一种新的治疗哮喘的方法，提供了一个机会来解决目前对儿童使用ICS的不良影响、在儿童中治疗更严重的哮喘、允许较低剂量的ICS、减少恶化以及改善与哮喘有关的生活质量的问题。所有这些都与生活在城市社区的儿童特别相关，那里有记录表明哮喘发病率增加。在市中心的儿童中，每天必须服用的处方药的依从性很低。抗-IgE是一种注射疗法，具有给药和观察治疗的好处。内城哮喘联盟将进行一项随机、双盲、安慰剂对照、平行分组的疗效和安全性试验，旨在比较250名6-20岁的内城儿童和青少年接受标准化专家护理(包括基本哮喘教育)的中到重度过敏性哮喘，以及250名类似的儿童和青少年接受Xolair类似的标准化专家护理和治疗。在为期60周的时间里，参与者将每两到四周接受一次Xolair或安慰剂皮下注射，同时接受标准化的专家护理。在双盲、安慰剂对照治疗期结束后，所有同意的参与者都将参加Xolair的开放标签24周治疗期。最后一次治疗后评估将在最后一次注射后大约16周进行。ICATA被设计为一项关于Xolair在患有中到重度过敏性哮喘的城市儿童和青少年中的有效性的“真实世界”试验。 这项研究结果可能会改变持续性过敏性哮喘的管理模式，这可能对居住在市中心的儿童特别有益，因为市中心似乎有独特的特征，如过敏原暴露和对治疗的依从性较差。 ICATA体重研究将与主要研究(附录1)并行进行，旨在研究体重/成分、哮喘发病率和炎症生物标志物之间的关系。这些数据可能为主要分析提供重要的协变量信息。主要终点将是哮喘症状的最大天数，定义为三个变量中的最高值：喘息、胸闷或咳嗽的天数；因哮喘而睡眠障碍的夜晚数量；以及参与者在两周内不得不放慢或停止游戏/体力活动的天数。

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. To evaluate the efficacy of Xolair , compared to placebo, when administered to inner-city children and adolescents with moderate-to-severe allergic asthma receiving standardized specialist care and basic asthma education. Anti-IgE, omalizumab, as a new and novel treatment for asthma represents an opportunity to answer current concerns regarding adverse effects of ICS use in children, treatment of more severe asthma in children allowing lower dose ICS, reducing exacerbations, and, improving the quality of life in relation to asthma. All of this is particularly relevant to children living in urban communities where increased asthma morbidity is documented. Adherence to prescribed medications required to be administered daily is low in inner-city children. Anti-IgE is an injection therapy and has the benefit of being an administered and observed therapy. The Inner-City Asthma Consortium will conduct a randomized, double-blind, placebo-controlled, parallel group efficacy and safety trial designed to compare 250 inner-city children and adolescents age 6-20 years old with moderate-to-severe allergic asthma receiving standardized specialist care, including basic asthma education, with 250 similar children and adolescents receiving comparable standardized specialist care and treatment with Xolair . Over a 60-week period, participants will receive subcutaneous injections of Xolair or placebo every two or four weeks, along with standardized specialist care. After the double-blind, placebo-controlled treatment period, all consenting participants will be enrolled in an open-label 24 week treatment period with Xolair . A final post-treatment evaluation will be conducted approximately 16 weeks following the final injection. ICATA has been designed as a "real-world" trial of the effectiveness of Xolair in urban children and adolescents with moderate-to-severe allergic asthma. The study results may change the paradigm of management for persistent allergic asthma that could be particularly beneficial for children living in the inner-city where there appear to be unique characteristics, such as allergen exposure and poor adherence to therapy. The ICATA Weight Study will be conducted in parallel with the main study (Appendix 1), and aims to examine the relationship between body weight/composition, asthma morbidity, and biomarkers of inflammation. These data may provide important covariate information for the main analyses. The primary endpoint will be the maximum number of asthma symptom days defined as the highest value among three variables: number of days with wheezing, tightness in the chest, or cough; number of nights with disturbed sleep due to asthma; and number of days on which the participant had to slow down or discontinue play/physical activities over a two-week period.