A Portable Dyspnea Relief Device for Episodic Breathlessness in COPD (PEP-buddy): Effect on Dyspnea Severity and Mechanism of Action
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Dyspnea severity
研究概览
简要总结
Chronic dyspnea is the most characteristic symptom of patients with Chronic Obstructive Pulmonary Disease (COPD), with intermittent increases during exercise and other events.Despite optimal standard therapy, episodic dyspnea is a common occurrence in COPD. Recently, the PEP buddy was developed which is an easy-to use, hands-free device that generates positive expiratory pressure (PEP). Although currently the available evidence is limited, it indicates that utilizing the PEP-buddy can result in enhancements in dyspnea during exertion, exertional desaturation and overall quality of life. More research is needed to evaluate the effectiveness of this device and the long term usability, as well as getting more insight in the mechanism of action. Therefore, the aim of our study is to explore the potential of this device for patients with COPD and episodic breathlessness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Age ≥40 years
- •Read, understood and signed Informed Consent
- •COPD Gold class II-IV/ B or E (FEV1<60% of predicted, CAT ≥10 points)
- •5. Optimized standard therapy according to the study physician
- •Episodic breathlessness requiring intervention (i.e. taking rest during physical activities, as needed inhalation medication, breathing techniques, as needed opioids) at least three days per week
排除标准
- •Other severe disease causing episodic breathlessness
- •Life expectancy ≤ 3 months
- •Exacerbation of COPD 4 weeks prior to inclusion
- •Change in COPD management targeted at breathlessness 8 weeks prior to inclusion
- •Inability to use the PEP buddy device
- •Currently participating in another interventional clinical study
- •Any other conditions, which, in the opinion of the investigator would make the patient unsuitable for inclusion, or could interfere with the patient participating in or completing the study.
研究组 & 干预措施
PEP-buddy
Patients will use the PEP-buddy as needed.
干预措施: PEP-buddy (Device)
结局指标
主要结局
Dyspnea severity
时间窗: 4 weeks
To investigate the effect of the portable dyspnea relief device on dyspnea severity after 4 weeks. Dyspnea severity is measured by the dyspnea domain of the chronic respiratory questionnaire (CRQ), this score of this scale ranges from 5-35, with a higher score indicating more severe dyspnea.
次要结局
未报告次要终点
研究者
JE Hartman
Principal investigator
University Medical Center Groningen