Oscillating Positive Expiratory Pressure Device for Mucous Clearing in Severe Exacerbation of COPD Requiring Hospitalization Targeting Outcome: A Randomized, Double Blind, Sham Controlled Trial (SIMPLE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- percent change of Forced expiratory volume in first second (FEV1)
研究概览
简要总结
Sputum production increases in acute exacerbation of COPD, both in amount and consistency. It increases airways obstruction and hence delays improvement and prolongs hospital stay. oscillating positive expiratory pressure (OPEP) devices were extensively studied in cystic fibrosis and bronchiectasis. Only seldom studied in chronic bronchitis. This study aims to measure the effects of mucous clearing device in hospitalized patients with acute exacerbation of COPD.
详细描述
In this study, investigators will investigate the change of objective measurements of lung functions and exercise capacity in addition to subjective measures of quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Randomization carried by a third party not involved in the study.
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
- •COPD patients, stages 3-4 according to GOLD guidelines 2016, with post bronchodilator FEV1/FVC < 70% of predicted and FEV1 < 50% with exacerbations necessitates hospital admission.
- •Smokers or Ex-smokers.
- •Able and willing to provide informed signed consent. Able and understanding the correct use of the bronchial clearing device.
- •Able to perform effectively spirometry.
- •Able and willing to receive the management plane as indicated including systemic steroids if seemed necessary.
排除标准
- •Other obstructive pulmonary diseases or those do not fulfill the criteria of COPD diagnosis.
- •Nonsmokers.
- •Presence of major comorbidity causing organ dysfunction as cardiac (including severe pulmonary hypertension), renal, or liver impairment (not including diabetes, arterial hypertension, or obesity).
- •Presence of lobar pneumonia.
- •Suspicion of bronchogenic malignancy.
- •Any other complication either at admission or during hospital stay as pneumothorax, pulmonary embolism, myocardial infarction, acute coronary syndrome, cerebrovascular accidents, ...
- •Patients unable or not willing to provide informed signed consent.
- •Patients unable to use the bronchial clearing device.
- •Patients unable to perform spirometry.
- •Patients unable or not willing to comply to the management plan or the study protocol.
- •Patients receiving regular oral steroids or non-selective beta blockers.
结局指标
主要结局
percent change of Forced expiratory volume in first second (FEV1)
时间窗: at 12 weeks after hospital discharge
change in volume of air expired forcefully in first second of expiration
percent change of Forced vital capacity (FVC)
时间窗: at 12 weeks after hospital discharge
change in total volume of air expired forcefully
percent change of six minutes walking distance (6MWD)
时间窗: at 12 weeks after hospital discharge
distance in meters a subject walk within 6 minutes
次要结局
- severe COPD exacerbation(12 weeks after discharge)
- change in health related quality of life(12 weeks after hospital discharge)
- change in score of shortness of breath(12 weeks after hospital discharge)
- hospital stay(first day of hospital admission to day of hospital discharge up to 12 weeks)
- hospital readmission(4 weeks after discharge)
- Moderate COPD exacerbation(12 weeks after discharge)
研究者
Hesham Raafat
Ass. Professor of chest medicine
Ain Shams University