PULMONARY FUNCTION TESTS FROM RAISED LUNG VOLUMES AS OUTCOME IN INFANTS WITH CF

以肺容量升高作为 CF 婴儿的肺功能测试结果

• 批准号: 7374337
• 负责人: GWENDOLYN S KERBY
• 金额: $ 1.03万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-24 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7374337
• 关键词: clinical trials; lung; measurement; respiratory airway volume; respiratory function; spirometry

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 conduct of clinical trials in infants with CF has been hindered by the lack of sensitive and reproducible outcome measures. In older subjects, spirometry is the gold standard for quantifying obstructive lung disease. Because infants cannot perform such a maneuver, measurements in the first several years of life have been restricted to expiratory flows obtained in the tidal volume range, where they are highly variable and poorly reproducible. Recently, techniques have been developed for measuring forced expiratory flows from raised lung volumes in infants and young children, for the first time producing flow-volume curves in infants comparable to those obtained by spirometry in older subjects. These new techniques have the potential to dramatically improve the understanding of the early natural history and pathophysiology of CF lung disease, and serve as reproducible outcome measures for clinical trials. Each subject will undergo testing at enrollment (Visit 1), 6 months and 12 months after enrollment (Visits 2 and 3), and at a study visit to be scheduled one month after visit 1 (the One-Month Reliability Visit). To ensure that subjects are not experiencing an intercurrent illness, testing at 6 and 12 months after enrollment may be carried out up to one month before or after each of these scheduled visits. The One Month Reliability Visit should be scheduled 28 to 35 days after Visit 1 (Month 0). If testing in that time frame is not feasible, the One-Month Reliability Visit may be re-scheduled 28 to 35 days before or after Visit 2 or 3 The goal of the proposed study is to test the hypothesis that measurements of fractional lung volumes and forced expiratory flows generated by the new raised volume pulmonary function testing technique will serve as useful outcome measures for clinical trials in infants with CF.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。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。列出的机构适用于该中心，这不一定是调查员的机构。缺乏敏感和可重复的结果指标，阻碍了患有CF婴儿的临床试验的进行。在较老的受试者中，肺活量测定法是量化阻塞性肺部疾病的金标准。由于婴儿无法进行这种操作，因此在潮汐体积范围内获得的呼气流中的最初几年的测量值限制在潮气范围内，在那里它们高度可变且可重复可再现。最近，已经开发了用于测量婴儿和幼儿肺部升高的强迫呼气流的技术，这是第一次在婴儿中与老年受试者中肺活量测定法获得的婴儿的流量曲线相当。这些新技术有可能显着提高对CF肺部疾病早期自然病史和病理生理学的理解，并作为临床试验的可再现结果指标。 每个受试者将在入学率（访问1），6个月零12个月（访问2和3）中进行测试，并在访问1个月后一个月（一个月可靠性访问）进行研究。为了确保受试者没有经历互动疾病，在每次预定的就诊之前或之后，在入学率后6和12个月进行测试。 一个月的可靠性访问应安排在访问1（0个月）后28至35天。如果在该时间范围内进行测试不可行，则可以在访问2或3之后的28至35天重新安排一个月的可靠性访问，拟议的研究的目标是测试分数肺体积和分数的测量值新升高的体积肺功能测试技术产生的强迫呼气流将作为CF婴儿的临床试验的有用结果指标。