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。 这项研究的目标是评估奥马珠单抗与安慰剂的疗效，当奥马珠单抗用于接受标准化专家护理和基本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。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人们所关注的以下问题：在儿童中使用ICS的不良反应，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。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。 2009年12月，内城哮喘协会进行了一项随机、双盲、安慰剂对照、平行分组的疗效和安全性试验，旨在比较6-20岁的内城儿童和青少年接受标准化专家治疗的中到重度过敏性哮喘的疗效和安全性，包括基本哮喘教育，以及类似的儿童和青少年接受与奥马珠单抗类似的标准化专家护理和治疗。在60周的时间里，参与者每两周或四周接受一次奥马利单抗或安慰剂皮下注射，同时接受标准化的专家护理。在双盲、安慰剂对照治疗期后，所有同意的参与者都参加了奥马珠单抗开放标签24周的治疗期。最后的治疗后评估是在最后一次注射后大约16周进行的。ICATA被设计为一项对患有中到重度过敏性哮喘的城市儿童和青少年使用奥马珠单抗有效性的“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。 主要终点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必须放慢或停止游戏/体育活动的天数。

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. The goal of the study was to evaluate the efficacy of omalizumab 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. Finishing in December 2009, he Inner-City Asthma Consortium conducted a randomized, double-blind, placebo-controlled, parallel group efficacy and safety trial designed to compare 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 similar children and adolescents receiving comparable standardized specialist care and treatment with omalizumab .Over a 60-week period, participants received subcutaneous injections of omalizumab or placebo every two or four weeks, along with standardized specialist care. After the double-blind, placebo-controlled treatment period, all consenting participants were enrolled in an open-label 24 week treatment period with omalizumab. A final post-treatment evaluation was conducted approximately 16 weeks following the final injection. ICATA was designed as a "real-world" trial of the effectiveness of omalizumab 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 primary endpoint was 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.