Correlation of Functional Respiratory Imaging Parameters With Lung Function Parameters and Patient Reported Outcome Measures During Exacerbation of COPD.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 4
- 主要终点
- Changes in functional respiratory imaging parameters
研究概览
简要总结
In this study the consequences of exacerbations will be visualized by high resolution computed tomography (HRCT) scan at functional residual capacity (FRC) and total lung capacity (TLC) as taken during an episode of exacerbation and after recovering. Changes in HRCT based airway dimensions and computational fluid dynamic (CFD) -based resistance values will be correlated with changes in patient reported outcomes (PROs) and lung function tests recorded at the same time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, ≥ 40 years old
- •COPD as defined by the global Initiative on obstructive lung disease4
- •Post-bronchodilator FEV1/FVC < 70% AND post-bronchodilator FEV1 <80%pred as documented in the last 5 years.
- •Smoking history of at least 10 pack-years
- •At entry in the study experiencing an exacerbation defined as an acute change in the patient 's baseline dyspnea, cough, and/or sputum that is beyond normal day to day variations, and that necessitates the administration or doubling of systemic corticosteroid treatment.
- •Patients must be able to understand and complete protocol requirements, instructions, questionnaires and protocol-stated restrictions.
- •Written and signed informed consent
排除标准
- •Pregnant or lactating females
- •Patient diagnosed with asthma
- •Patient with pneumonia as defined radiologically at the start of the exacerbation
- •Patient with a history of or presence of lung cancer
- •Patient with an indication for non-invasive ventilation
- •Patient unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
- •Patient who received any investigational new drug within the last 4 weeks prior to visit 1.
研究组 & 干预措施
No treatment
CT-scans will be taken in the study. The EC of the University hospital antwerp considers this as an intervention.
干预措施: Functional Respiratory Imaging (Radiation)
结局指标
主要结局
Changes in functional respiratory imaging parameters
时间窗: Baseline (= during exacerbation) and after about 6 weeks (= after recovering)
The primary objective of this study is to evaluate whether changes in HRCT based airway dimensions and Computational Fluid Dynamic (CFD)-based resistance values correlate with changes in lung function parameters, under the conditions of exacerbation of COPD as well as after recovering from exacerbation.
Changes in lung function parameters
时间窗: Baseline (= during exacerbation) and after about 6 weeks (= after recovering)
The primary objective of this study is to evaluate whether changes in HRCT based airway dimensions and Computational Fluid Dynamic (CFD)-based resistance values correlate with changes in lung function parameters, under the conditions of exacerbation of COPD as well as after recovering from exacerbation.
次要结局
- Changes in patient reported outcome (PRO) measures(Baseline (= during exacerbation) and after about 6 weeks (= after recovering))