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临床试验/NCT02296489
NCT02296489已完成不适用

An Association Between Asthma Severity and Capnography Parameters

Oridion1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
73
试验地点
1
主要终点
Measuring the change in expired CO2 over time in asthma patients during the methacholine challenge.

研究概览

简要总结

Asthma is a common chronic disorder of the airways characterized by periods of reversible airflow obstruction known as asthma episodes or attacks. Asthma attacks are caused by chronically hyperactive (contraction of the muscles surrounding the airways) and inflamed airways, leading to airflow obstruction, and may be mild, moderate, or severe enough to become life-threatening events. Severity of asthma exacerbation is assessed through medical history and lung function measurements with Spirometer and requires full cooperation of the patient. Thus, in uncooperative populations or during emergency medical situations the spirometer cannot be used. As an alternative, capnography data has been proposed as an indicator of bronchospasm in asthma. Previous studies found correlations between the capnography parameters and methacholine challenge in asthma patients. However, the relationship between capnography parameters and severity of asthma or severity of asthma exacerbation have not been well characterized. The study hypothesis is that within the clinical population that is invited to do the methacholine challenge, a different waveform pattern in asthma patients will be detected and possibly a correlation between the severity of obstruction and pattern of waveform during the methacholine challenge. In this proposed feasibility observational study, sixty subjects, both men and women, who will be invited to participate in the methacholine challenge in the Institute of Pulmonary Medicine at Rabin Medical Center, will be recruited to the study. Respiratory information will be recorded using the CapnostreamTM20p while the subjects will wear the non-invasive Smart CapnoLine® Plus sampling line. Additionally, FeNO will be measured using a DENOX 88 device during the methacholine challenge.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The subject was invited to participate in methacholine challenge for the purposes of clinical assessment, with no relation to this study
  • Ability to sign informed consent form

排除标准

  • Cannot or not willing to have capnography measurement during the entire methacholine challenge
  • Has or had in the past chronic obstructive pulmonary disease (COPD)

结局指标

主要结局

Measuring the change in expired CO2 over time in asthma patients during the methacholine challenge.

时间窗: 1 year

次要结局

  • Finding a correlation between change in expired CO2 and fraction of exhaled nitric oxide (FeNO).(1 year)
  • Finding correlations between changes in capnography parameters and the severity of asthma as reflected by preliminary FEV1, forced vital capacity (FVC), FEV1/FVC, and peak expiratory flow rate.(1 year)
  • Finding a correlation between the change in expired CO2 and the severity of asthma as reflected by PC20.(1 year)
  • Finding a correlation between the change in expired CO2 and the severity of asthma as reflected by the frequency of symptoms according the Asthma Severity Tool (AST).(1 year)

研究者

发起方
Oridion
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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