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.

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。 该研究的目的是评估奥马珠单抗与安慰剂相比对接受标准化专科护理和基础哮喘教育的中重度过敏性哮喘儿童和青少年的疗效。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。 2009年12月，内城哮喘联盟进行了一项随机、双盲、安慰剂对照、平行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科护理的中度至重度过敏性哮喘，包括基础哮喘教育，在60周的时间里，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，沿着标准化的专科护理。 在双盲、安慰剂对照治疗期后，所有知情同意的参与者均入组奥马珠单抗开放标签24周治疗期。在末次注射后约16周进行最终治疗后评价。ICATA被设计为奥马珠单抗在城市儿童和青少年中重度过敏性哮喘患者中有效性的“真实世界”试验。 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。 主要终点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;因哮喘而睡眠紊乱的夜晚数量;以及参与者在两周内不得不放慢或停止游戏/体育活动的天数。