Assessing the Utility of Peak Inspiratory Flow as a Predictor for COPD Exacerbations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 13
- 主要终点
- Exacerbations
研究概览
简要总结
This is an international, mulitcentre, observational, prospective study into Peak Inspiratory Flow in COPD patients that aims to: A) Determine the prevalence of suboptimal Peak Inspiratory Flow (PIF) and inadequate inhaler choice and assess the baseline characteristics of these groups. B) Assess the clinical role of PIF and inhaler choice in predicting COPD exacerbations and symptom burden. C) Assess the variability and correlation of PIF with other lung function measurements and CAT score in stable COPD. It is a 12 month study comprising one baseline assessment and 2 follow-up visits at 6 and 12 months.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spirometry-defined COPD (i.e. post-bronchodilator FEV1/FVC<0.7)
- •Age ≥40 years
- •Smokers or ex-smokers of at least 10 pack-years
- •Clinically stable COPD (no exacerbations in the last 4 weeks)
- •Capable of performing serial lung function tests
- •Prescribed inhaled medication for at least 6 months
排除标准
- •Occurrence of an COPD exacerbation during the previous 4 weeks
- •Have any concomitant chronic respiratory condition other than asthma or bronchiectasis (e.g. cystic fibrosis, lung fibrosis, tuberculosis)
- •Are unable to understand the instructions of the study or to fill the questionnaires
- •Are unwilling to sign the informed consent
- •Are participating in a clinical trial
结局指标
主要结局
Exacerbations
时间窗: 12 months
Time to first exacerbation associated with different levels of PIF.
Prevalence of suboptimal PIF and inadequate inhaler choice.
时间窗: Baseline
Determine the prevalence of suboptimal PIF and inadequate inhaler choice.
次要结局
- Variability and correlation of PIF(Baseline, 6 and 12 months)
- Exacerbation rate(6 and 12 months)
- PIF and symptom burden(Baseline, 6 and 12 months)
- Mortality(6 and 12 months)