Nitric Oxide Breath Analyzer for Asthma Patients

适用于哮喘患者的一氧化氮呼吸分析仪

• 批准号: 7052988
• 负责人: John W Birks
• 金额: $ 8.05万
• 依托单位: 2B TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-02-01 至 2007-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7052988
• 关键词: asthma; biotechnology; breath tests; clinical research; diagnosis design /evaluation; human subject; nitric oxide; portable biomedical equipment; respiratory disorder diagnosis; respiratory gas analyzer; ultraviolet spectrometry

DESCRIPTION (provided by applicant): In this proposal we respond to the PHS 2005-2 Omnibus Solicitation's call for the development of diagnostic tools for "non-invasive methodologies for measuring airways inflammation in asthma." We propose to develop, test and evaluate a low cost, portable analyzer for the measurement of nitric oxide (NO) in human breath as an indicator of airway inflammation, especially for the diagnosis and treatment of asthma. A method for NO measurement in exhaled breath recently was approved by the U.S. Food and Drug Administration and its equivalent in the European Union for the purpose of diagnosing, monitoring and treating patients with asthma and other airway diseases. The instrumental approach (NIOX(r) of Aerocrine AB) makes use of the highly sensitive technique of NO + O3 chemiluminescence, but that method is too complicated and expensive for use in the home. In preliminary results, we have demonstrated the use of a much simpler technique that uses the NO + O3 reaction in a different way. Instead of measuring chemiluminescence, the loss of O3 is measured by UV absorption at 254 nm using a low pressure mercury lamp. This approach, which recently has been successfully marketed in for atmospheric measurements, gives adequate precision (¿2 ppbv) and accuracy (¿2%) for breath analysis. In addition to being small, light weight and having low power requirements, this new approach eliminates the need for gas standards contained in high pressure gas cylinders. The simplified "stopped flow" design proposed here eliminates the possibility of interference from major components in breath such as water vapor and carbon dioxide. Because of their slow reaction, VOCs such as isoprene also are not expected to interfere. In Phase I we will develop and test a prototype instrument that will be used in a clinical intercomparison with the FDA-approved NIOX apparatus for establishment of equivalency during Phase II. RELEVANCE TO PUBLIC HEALTH The objective of this work is to develop a low cost, accurate and reliable instrument for use in the home that can be used for optimizing the use of therapeutic drugs in the management of asthma.

描述（由申请人提供）：在本提案中，我们响应PHS 2005-2综合征集，要求开发“用于测量哮喘气道炎症的非侵入性方法”的诊断工具。我们建议开发、测试和评估一种低成本的便携式分析仪，用于测量人体呼吸中的一氧化氮（NO），作为气道炎症的指标，特别是用于哮喘的诊断和治疗。最近，美国食品和药物管理局（fda）和欧盟（eu）批准了一种测量呼出气体中一氧化氮的方法，用于诊断、监测和治疗哮喘和其他呼吸道疾病患者。仪器方法（Aerocrine AB的NIOX(r)）利用了高灵敏度的NO + O3化学发光技术，但该方法过于复杂和昂贵，无法在家庭中使用。在初步结果中，我们已经展示了一种更简单的技术，即以不同的方式使用NO + O3反应。代替测量化学发光，使用低压汞灯在254 nm处通过紫外吸收来测量O3的损失。这种方法最近已成功地用于大气测量，为呼气分析提供了足够的精度（2 ppbv）和准确性（2%）。除了体积小、重量轻、功耗低之外，这种新方法还不需要高压气瓶中的气体标准。这里提出的简化“止流”设计消除了呼吸中主要成分（如水蒸气和二氧化碳）干扰的可能性。由于异戊二烯等挥发性有机化合物反应缓慢，预计也不会对其产生干扰。在第一阶段，我们将开发和测试一种原型仪器，该仪器将用于与fda批准的NIOX仪器进行临床比较，以在第二阶段建立等效性。这项工作的目的是开发一种低成本、准确和可靠的家用仪器，可用于优化哮喘治疗药物的使用。