Impulse Oscillometry for Prognostication in Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- Performance of the 5-Hz reactance of the respiratory system (Xsr5) variation at 3 months, for the diagnosis of rapid decline in lung function.
研究概览
简要总结
A 5-point decline of forced vital capacity expressed as % predicted, over 6 months, is the current definition of disease progression (fast decline in lung function) in idiopathic pulmonary fibrosis. There is a need for techniques allowing to characterize disease progression earlier, so that treatment may be adapted as early as possible in the lack of a response.
Hypothesis. Our hypothesis is that 3-month changes of lung function parameters measured by a novel technique, impulse oscillometry, predicts 6-month changes in forced vital capacity in idiopathic pulmonary fibrosis.
详细描述
A 5-point decline of forced vital capacity expressed as % predicted, over 6 months, is the current definition of disease progression (fast decline in lung function) in idiopathic pulmonary fibrosis. There is a need for techniques allowing to characterize disease progression earlier, so that treatment may be adapted as early as possible in the lack of a response.
Hypothesis. Our hypothesis is that 3-month changes of lung function parameters measured by a novel technique, impulse oscillometry, predicts 6-month changes in forced vital capacity in idiopathic pulmonary fibrosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 45 years.
- •Idiopathic Pulmonary Fibrosis defined Interstitial Lung Diseases with 1) lack of any known cause for Interstitial Lung Diseases and 2) either the "definite usual interstitial pneumonia" pattern at CT scan, or the usual interstitial pneumonia (definite, probable or possible) pattern at lung biopsy, according to the Lung Function Group of the French Pulmonology Society criteria.
排除标准
- •History of chronic obstructive airway disease.
- •History of congestive heart failure.
- •Emphysema-fibrosis syndrome, defined as emphysematous lesions involving >15% of the lung area at the level of the aortic arch (upper lobes).
- •History of lower respiratory infection or acute respiratory failure of any cause less than 90 days before inclusion.
- •Opposition to data processing.
结局指标
主要结局
Performance of the 5-Hz reactance of the respiratory system (Xsr5) variation at 3 months, for the diagnosis of rapid decline in lung function.
时间窗: Baseline, 3 months, 6 months
Receiver operating characteristics curves will be used to determine diagnostic performance.
次要结局
- Performance of the 3-month variation in additional impulse oscillometry parameters for the diagnosis of rapid decline in lung function(Baseline, 3 months, 6 months)
- Performance of baseline impulse oscillometry parameters for the diagnosis of rapid decline in lung function(Baseline, 3 months, 6 months)
- Assess correlations between impulse oscillometry parameters and exertional dyspnea(Baseline, 3 months, 6 months)
- Assess correlations between impulse oscillometry parameters and the extent of either fibrosis or emphysema lesions on CT scans(Baseline)
- Assess correlations between impulse oscillometry parameters and forced vital capacity(Baseline, 3 months, 6 months)