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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 该研究的目的是与安慰剂相比，在接受标准化的专业护理和基本哮喘教育的城市内部儿童和青少年时，要评估omalizumab与安慰剂相比的疗效。抗Ige，Omalizumab作为对哮喘的一种新颖而新颖的治疗方法，这是一个机会，可以回答有关儿童使用IC的不利影响的关注点，治疗儿童更严重的哮喘，允许较低剂量的ICS，减少加重，并改善与哮喘相关的生活质量。所有这些都与居住在城市社区中的儿童特别相关，这些儿童记录了哮喘发病率的增加。 在城市内部儿童中，每天需要服用所需的处方药物的依从性较低。抗IGE是一种注射疗法，具有接受和观察到的治疗的好处。 他于2009年12月完成后，他进行了城市内部哮喘财团进行了一项随机，双盲，安慰剂对照，平行的团体效能和安全试验，旨在比较6-20岁的城市内部儿童和青少年，中度至中等范围内，接受中等至方向的过敏性哮喘治疗量，包括标准的专家和类似的专家，包括基本的专家，并具有类似的儿童培训，并具有类似的儿童培训，并具有类似的儿童培训，并且在一个60周的期间，参与者每两周或四个星期就接受了Omalizumab或安慰剂的皮下注射，以及标准化的专业护理。 在双盲，安慰剂控制的治疗期之后，所有同意的参与者均纳入Omalizumab的24周开放标签治疗期。最终注射后约16周进行了最终的治疗后评估。 ICATA被设计为Omalizumab对中等至重度过敏性哮喘的城市儿童和青少年有效性的“现实世界”试验。 该研究结果可能会改变持续过敏性哮喘管理的管理范式，这可能对生活在似乎存在独特特征的城市中的儿童特别有益，例如过敏原暴露和对治疗的依从性不佳。 主要终点是定义为三个变量中最高值的哮喘症状天数量的最大数量：喘息的天数，胸部紧绷或咳嗽；由于哮喘而导致睡眠不安的夜晚；以及参与者在为期两周的时间内必须放慢或停止玩耍/体育活动的天数。