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

内城区哮喘抗 ​​IGE 治疗 (ICATA)

• 批准号: 7608278
• 负责人: STEPHEN John TEACH
• 金额: $ 0.76万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7608278
• 关键词: 20 year old; Adherence; Adolescent; Adverse effects; Age; Allergens; Appendix; Asthma; Biological Markers; Body Weight; Caring; Characteristics; Chest; Child; Childhood Asthma; Communities; Computer Retrieval of Information on Scientific Projects Database; Consent; Coughing; Daily; Data; Dose; Double-Blind Method; Education; End Point; Enrollment; Evaluation; Extrinsic asthma; Funding; Grant; Inflammation; Injection of therapeutic agent; Institution; Label; Life; Morbidity - disease rate; Numbers; 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; Week; Weight; Wheezing; Xolair; anti-IgE; day; design; effectiveness trial; improved; inner city; novel; omalizumab; 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. 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.

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。 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以出现在其他 CRISP 条目中 列出的机构是。 对于中心来说，它不一定是研究者的机构。 评估 Xolair 的功效¿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 的不良反应、治疗儿童更严重哮喘、允许使用较低剂量的 ICS、减少病情恶化以及提高治疗质量等问题提供了机会。所有这些都与生活在哮喘发病率较高的城市社区的儿童尤其相关。内城儿童每天服用抗 IgE 药物的发病率较低，并且有利于内城哮喘协会进行随机治疗。 ，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 岁内城区儿童和青少年，患有中度至重度过敏性哮喘，接受标准化专业护理，包括基本护理哮喘教育，250 名类似的儿童和青少年接受 Xolair 的类似标准化专业护理和治疗。在 60 周的时间内，参与者将接受 Xolair 的皮下注射。每两周或每四周使用一次安慰剂，以及标准化的专科护理 在双盲、安慰剂对照治疗期结束后，所有同意的参与者将参加 Xolair 的开放标签 24 周治疗期。最终的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 Xolair 有效性的“真实世界”试验。患有中度至重度过敏性哮喘的城市儿童和青少年。 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。 ICATA 体重研究将与主要研究（附录 1）同时进行，旨在检查体重/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。主要终点是哮喘症状天数，定义为三个变量中的最高值：出现喘息、胸闷或咳嗽的天数；因哮喘而睡眠不安的夜晚数以及服用药物的天数；参与者有在两周内减慢或停止游戏/体育活动。