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

内城区哮喘抗 ​​IGE 治疗 (ICATA)

• 批准号: 8167297
• 负责人: STEPHEN John TEACH
• 金额: $ 1.97万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-01-20 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8167297
• 关键词: 20 year old; Adherence; Adolescent; Adverse effects; Aftercare; Age; Allergens; Asthma; Caring; Characteristics; Chest; Child; Childhood Asthma; Clinical Trials Design; Communities; Computer Retrieval of Information on Scientific Projects Database; Consent; Coughing; Dose; Double-Blind Method; Education; Enrollment; Evaluation; Extrinsic asthma; Funding; Goals; Grant; Injection of therapeutic agent; Institution; Life; Morbidity - disease rate; Participant; Pharmaceutical Preparations; Physical activity; Placebo Control; Placebos; Play; Quality of life; Randomized; Research; Research Personnel; Resources; Safety; Sleep; Source; Specialist; Subcutaneous Injections; Symptoms; United States National Institutes of Health; Wheezing; anti-IgE; design; effectiveness trial; improved; inner city; novel; omalizumab; open label; treatment duration

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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 该研究的目的是评估奥马珠单抗与安慰剂相比的疗效，当对接受标准化专业护理和基础哮喘教育的患有中度至重度过敏性哮喘的市中心儿童和青少年进行治疗时。抗 IgE 奥马珠单抗作为一种新的哮喘治疗方法，为解决当前关于儿童使用 ICS 的不良影响、治疗儿童更严重的哮喘（允许使用较低剂量的 ICS）、减少病情恶化以及改善与哮喘相关的生活质量等问题提供了机会。所有这些都与生活在城市社区的儿童尤其相关，那里的哮喘发病率有所增加。 内城区儿童对每日服用处方药的依从性较低。抗 IgE 是一种注射疗法，具有给药和观察治疗的优点。 内城哮喘联盟于 2009 年 12 月完成了一项随机、双盲、安慰剂对照、平行组疗效和安全性试验，旨在比较接受标准化专业护理（包括基础哮喘教育）的内城 6-20 岁中度至重度过敏性哮喘儿童和青少年，以及接受类似标准化专业护理和奥马珠单抗治疗的类似儿童和青少年。 在 60 周的时间内，参与者每两周或四周接受一次奥马珠单抗或安慰剂的皮下注射，并接受标准化的专业护理。 在双盲、安慰剂对照治疗期结束后，所有同意的参与者都被纳入奥马珠单抗开放标签的 24 周治疗期。最后一次注射后大约 16 周进行最终的治疗后评估。 ICATA 被设计为一项“真实世界”试验，旨在验证奥马珠单抗对患有中度至重度过敏性哮喘的城市儿童和青少年的有效性。 该研究结果可能会改变持续性过敏性哮喘的治疗模式，这对于居住在市中心的儿童特别有益，因为那里似乎具有独特的特征，例如过敏原暴露和治疗依从性差。 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；因哮喘而睡眠受到干扰的夜晚数；以及参与者在两周内必须放慢或停止游戏/身体活动的天数。