Multi-centre, Long-term Comparative Trial of High Frequency Chest Wall Oscillation Versus Positive Expiratory Pressure Mask in the Treatment of Cystic Fibrosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 25
- 主要终点
- Difference in the number of respiratory exacerbations during the 1 year study period
研究概览
简要总结
This study is a preliminary study designed to determine the safety and effectiveness of HFCWO using the InCourage vest system as an airway clearance technique for the treatment of CF. The study will compare HFCWO to the most commonly used airway clearance technique in Canada, namely the Positive Expiratory Pressure technique in patients with CF over a period of one year. As this is a preliminary study, it will not be able to determine if the vest is equivelant to PEP, but will provide the information needed to plan a larger study to answer that question.
详细描述
Objective This is a pilot study to evaluate the long-term clinical efficacy of high frequency chest wall oscillation (HFCWO) using the inCourage vest system, compared to positive expiratory pressure mask (PEP) in the treatment of patients with cystic fibrosis.
Study Design This is a one year prospective multi-centre randomized controlled trial of HFCWO versus PEP as airway clearance techniques in patients with cystic fibrosis. Number of respiratory exacerbations will be compared between the two treatment arms. Slope of percent predicted in FEV1, activity level, quality of life, cost analysis and subject satisfaction will also be compared.
Number of subjects Enrollment will be completed after 170 subjects have been recruited, approximately 85 in each arm.
Number of sites The study will involve between 14 CF centres in Canada.
PERSCRIBED AIRWAY CLEARANCE TECHNIQUE The test airway clearance technique is the
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
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 6 years of age or older at enrollment and be competent in performing spirometry.
- •Confirmed diagnosis of CF.
- •FEV1> 45% predicted as calculated by Wang reference equations
- •Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
- •Clinically stable at enrollment with no evidence of respiratory exacerbation within a month of enrollment as assessed by the site CF Physician.
- •Willingness to adhere to prescribed treatment regimen.
排除标准
- •Diagnosis of Allergic Broncho-Pulmonary Aspergillosis, or a persistent culture for B.cepacia complex within the previous 1 year period
- •.On active treatment for non Tuberculous Mycobacterium.
- •Use of intravenous antibiotics within the previous 14 days of enrollment.
- •Initiation and or change in maintenance therapy within 14 days of enrollment.
- •Use of systemic corticosteriods (1mg/kg if < 20 kg or 20 mg of prednisone per day) within 14 days of enrollment.
- •Concurrent participation in another study that could potentially affect the present study.
- •Haemoptysis of over 20 mls on more than 2 occasions within the previous 30 days from enrollment.
- •A pneumothorax in the six months preceding the study.
- •Presence of a condition or abnormality that in the opinion of the site CF Physician would compromise the safety of the patient or the quality of the data.
结局指标
主要结局
Difference in the number of respiratory exacerbations during the 1 year study period
时间窗: 1 year
次要结局
- The time to the first respiratory exacerbation. Change in FEV1 measured as difference in the yearly mean rate of decline. Cost analysis between the two groups. Quality of life questionnaire. Patient satisfaction questionnaire and Adherence to treatment.(1 year)