Assessing Exercise Capacity After PulseHaler™ Treatment in Chronic Obstructive Lung Disease (GOLD) II-IV of Chronic Obstructive Pulmonary Disease (COPD) Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 104
- 主要终点
- Constant Work Rate (CWR) Cardiopulmonary Exercise Test on cycle ergometer
研究概览
简要总结
Prospective, sham controlled, interventional study to evaluate the extent to which PulseHaler improves the functional status of Chronic Obstructive Lung Disease (GOLD) II-IV Chronic obstructive pulmonary disease (COPD) patients.
详细描述
PulseHaler™ is a pulsating positive expiratory pressure ventilation device for treatment of COPD . PulseHaler™ is pre-programmed to deliver airflow at pre-defined frequencies and for pre-defined lengths of time.
The study is intended to evaluate the extent to which PulseHaler improves the functional status of GOLD II-IV COPD patients after 4 weeks of treatment 3x / day.
And To evaluate the extent to which improvements are maintained over a subsequent 2 weeks when treatments are tapered to 1x daily.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Investigator confirmation of GOLD II-IV COPD
- •Successful completion of Incremental Exercise Test (IET)
- •FEV1 < 60% predicted
- •Post-bronchodilator FEV1/FVC ≤ 0.7
- •55-75 years old
- •Signed informed consent by subject (required cognitive capacity)
排除标准
- •SpO2<80% at IET
- •Unable to achieve a CWR test duration at visit 2 between 3 and 8 minutes
- •Exercise limitation unrelated to diagnosis of COPD
- •Systemic (oral, IV, IM) steroid use for acute exacerbation in the 30 days prior to screening
- •Baseline CAT Score <10
- •Women at the age of fertility, who are pregnant, or plan pregnancy, or do not use contraceptives
- •Severe cardiac disease, e.g., Congestive Heart Failure grade , hemodynamic instability,
- •Acute myocardial infarction within last 3 months
- •Coronary artery bypass graft within last 3 months
- •Epilepsy, raised intracranial pressure, acute sinusitis or nosebleed
- •Pulmonary embolism, untreated air leaks, tension pneumothorax, bronchopleural fistula, active hemoptysis, pulmonary haemorrhage, Large pulmonary bullae, intrathoracic obstruction from tumor or foreign body
- •Unhealed dental, head, neck, ear, nose & throat, thoracic or upper gastro-intestinal tract surgery or trauma
- •Unhealed broken ribs
- •Esophageal varices
- •Anxiety, Depression, history of Mental illness
- •Dependence on positive pressure ventilation (i.e. 24/7 non-invasive ventilation).
- •Cannot perform spirometry
- •Enrollment in another interventional study
- •Any medical condition for which the investigator deems the subject unable to participate in the study
结局指标
主要结局
Constant Work Rate (CWR) Cardiopulmonary Exercise Test on cycle ergometer
时间窗: at day 29
Change from baseline in duration of constant work rate exercise testing (TLIM)
次要结局
- COPD Assessment Test (CAT)(at day 29 and 43)
- Pulmonary functions test- FVC(at day 29 and 43)
- Pulmonary functions test- FEV1(at day 29 and 43)
- Pulmonary functions test- FRC(at day 29 and 43)
- Pulmonary functions test - FEF25-75(at day 29 and 43)
- Patients compliance rate to treatment(at day 29 and 43)
- CWR Cardiopulmonary Exercise Test on cycle ergometer- TLIM(at day 43)
- CWR Cardiopulmonary Exercise Test on cycle ergometer- VE(at day 29 and 43)
- CWR Cardiopulmonary Exercise Test on cycle ergometer- HR(at day 29 and 43)
- CWR Cardiopulmonary Exercise Test on cycle ergometer- SpO2(at day 29 and 43)
- CWR Cardiopulmonary Exercise Test on cycle ergometer- VT(at day 29 and 43)
- CWR Cardiopulmonary Exercise Test on cycle ergometer- RR(at day 29 and 43)