CHILDHOOD ASTHMA: INITIATION AND INTERVENTION

儿童哮喘：起始和干预

• 批准号: 6184640
• 负责人: Robert F Lemanske
• 金额: $ 63.92万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-30 至 2004-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6184640
• 关键词: adolescence (12-20); age difference; asthma; child (0-11); clinical research; cooperative study; corticosteroids; drug screening /evaluation; human subject; human therapy evaluation; inhibitor /antagonist; leukotrienes; pediatrics; respiratory disorder chemotherapy

Investigators that constitute a pediatric asthma clinical research network will have an extraordinary opportunity and responsibility to advance the field in the diagnosis, pathogenesis, and treatment of children and adolescents with asthma. This research team should have the courage and insight to be both innovative and aspiring in the development of protocols to address questions currently unanswered due to shortcomings in trial design in previously conducted studies. Clinical trials designed to evaluate a particular form of treatment for childhood asthma need first, to recognize the potential for the intervention to modulate either the initiation of the asthmatic phenotype or the induction of asthma exacerbations once the syndrome has become established; and second, to comprehensively evaluate the short- and long-term consequences of any treatment intervention. Ideally, appropriately designed protocols should provide insight into selecting the right child, to treat at the right time, and with the right medication. To address these needs, we propose two protocols that bookend the extremes of important questions in pediatric asthma in age groups (infancy and adolescence) in which asthma therapy has been incompletely examined. In the first protocol, we propose to evaluate the safety and efficacy of two types of long term controller therapies (an inhaled corticosteroid and a leukotriene receptor antagonist) in children divided into two separate phenotypic groups based on risk factors previously demonstrated to be associated with persistent (asthma) versus transient wheezing. In the second protocol, we propose to evaluate the effects of inhaled corticosteroids during a period of growth and development that many clinicians are concerned about (adolescence), but a time period that has never been critically examined. Although both protocols are challenging, we consider them to be potential examples of the types of comprehensive clinical investigations a pediatric oriented network should be capable of developing and conducting in a way that will provide clinically relevant and useful information, while at the same time establishing and maintaining acceptable standards of safety in these age groups.

构成儿科哮喘临床研究网络的研究人员将拥有非凡的机会和责任来推进儿童和青少年哮喘的诊断、发病机制和治疗领域的发展。 该研究团队应该有勇气和洞察力，在制定方案时既具有创新性又富有雄心，以解决由于先前进行的研究中试验设计的缺陷而目前尚未解答的问题。旨在评估儿童哮喘的特定治疗形式的临床试验首先需要认识到一旦综合征确立，干预措施调节哮喘表型的开始或诱导哮喘恶化的潜力；其次，全面评估任何治疗干预的短期和长期后果。 理想情况下，适当设计的方案应该有助于深入了解选择合适的孩子、在正确的时间进行治疗并使用正确的药物。为了满足这些需求，我们提出了两个方案，解决了哮喘治疗尚未得到充分检验的年龄组（婴儿期和青春期）小儿哮喘重要问题的极端情况。 在第一个方案中，我们建议评估两种类型的长期控制疗法（吸入皮质类固醇和白三烯受体拮抗剂）在儿童中的安全性和有效性，根据先前证明与持续存在相关的危险因素，将其分为两个不同的表型组。 （哮喘）与短暂性喘息。 在第二个方案中，我们建议评估吸入皮质类固醇在许多临床医生关注的生长和发育时期（青春期）的影响，但这个时期从未经过严格检查。 尽管这两种协议都具有挑战性，但我们认为它们是全面临床调查类型的潜在示例，面向儿科的网络应该能够以提供临床相关和有用信息的方式开发和进行，同时建立和实施在这些年龄组中保持可接受的安全标准。