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

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 评价与安慰剂相比，在接受标准化专科护理和基础哮喘教育的市中心中重度过敏性哮喘儿童和青少年中使用Xolair的疗效。抗IgE药物奥马珠单抗作为一种新型的哮喘治疗药物，为解决目前关于儿童使用ICS的不良反应、治疗更严重的儿童哮喘（允许使用较低剂量的ICS）、减少急性发作以及改善与哮喘相关的生活质量的问题提供了机会。所有这些都与生活在城市社区的儿童特别相关，那里的哮喘发病率增加。 在市中心的儿童中，每天服用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益处。 Inner-City Asthma Consortium将进行一项随机、双盲、安慰剂对照、平行组疗效和安全性试验，旨在比较250名6-20岁的市中心儿童和青少年接受标准化专科护理的中度至重度过敏性哮喘，包括基础哮喘教育，250名类似的儿童和青少年接受了类似的标准化专家护理和索莱尔治疗。在60周的时间里，参与者将每两周或四周接受一次Xolair或安慰剂的皮下注射，同时沿着标准化的专家护理。 在双盲、安慰剂对照治疗期后，所有知情同意的受试者将入组为期24周的Xolair开放标签治疗期。将在末次注射后约16周进行最终治疗后评价。ICATA被设计为一个“真实世界”的试验，在城市儿童和青少年中度至重度过敏性哮喘患者中测试Xolair的有效性。 研究结果可能会改变持续性过敏性哮喘的管理模式，这可能对生活在市中心的儿童特别有益，那里似乎有独特的特征，如过敏原暴露和对治疗的依从性差。 ICATA体重研究将与主研究平行进行（附录1），旨在检查体重/组成、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天数的最大值，定义为三个变量中的最高值：喘息、胸闷或咳嗽的天数;因哮喘导致睡眠障碍的夜晚数;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.