A Comparison of Five Airway Clearance Techniques in the Treatment of Adults With Cystic Fibrosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 75
- 主要终点
- Forced expiratory volume in one second (FEV1)
研究概览
简要总结
The study was to evaluate the long term effects, over one year, of five airway clearance techniques used by people with cystic fibrosis (active cycle of breathing techniques, autogenic drainage, positive expiratory pressure and oscillating positive expiratory pressure (R-C Cornet and Flutter)). The primary outcome measure was forced expiratory volume in one second (FEV1)and the null hypothesis was that there are no differences among the regimens.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cystic fibrosis (genotype or sweat sodium concentration greater than 70 mmol/litre)
- •Forced expiratory volume in one second greater than or equal to 25% predicted, on assessment for entry to the study.
排除标准
- •Evidence of a current respiratory exacerbation (Thornton et al 2004)
- •Current severe haemoptysis
- •Past history of pneumothorax
- •Awaiting lung / heart-lung transplantation
- •Pregnancy
- •Recent (within 3 months) acquisition of Burkholderia cepacia
研究组 & 干预措施
1
Active cycle of breathing techniques
干预措施: Airway clearance technique (Procedure)
2
Autogenic drainage
干预措施: Airway clearance technique (Procedure)
3
R-C Cornet
干预措施: Airway clearance technique (Procedure)
4
Flutter
干预措施: Airway clearance technique (Procedure)
5
PEP
干预措施: Airway clearance technique (Procedure)
结局指标
主要结局
Forced expiratory volume in one second (FEV1)
时间窗: 48 weeks
次要结局
- Quality of life (Short Form-36 and Chronic Respiratory Questionnaire)(48 weeks)
- Exercise capacity (Modified shuttle test)(48 weeks)