Effectiveness and Safety of Inhaling Hypertonic Saline in the Functional Exercise Capacity of Patients With Chronic Obstructive Pulmonary Disease: a Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 主要终点
- Functional exercise capacity
研究概览
简要总结
The use of inhaled hypertonic saline has been extensively documented in asthma, bronchiectasis, cystic fibrosis and COPD as method of bronchial challenge and sputum induction, but studies that evaluated others endpoints are required. The objective of this study was to analyse the effects of inhaling hypertonic saline compared with placebo with respect to functional exercise capacity, dyspnoea and quality of life. In a double-blind randomised parallel placebo-controlled trial, conducted at the Clínicas Integradas of the Evangelical Faculty of Paraná,sixty-eight patients (age 67 ± 6.5 years; FEV1 38.9 ± 16.2 predicted) were randomised to inhale 3% hypertonic saline (n=34) or placebo (n=34), combined with a program of exercise, three times a week, for 8-weeks.
详细描述
Background: The use of inhaled hypertonic saline has been extensively documented in asthma, bronchiectasis, cystic fibrosis and COPD as method of bronchial challenge and sputum induction, but studies that evaluated others endpoints are required. Objective: To analyse the effects of inhaling hypertonic saline compared with placebo with respect to functional exercise capacity, dyspnoea and quality of life. Design and Setting: This was a double-blind randomised parallel placebo-controlled trial, conducted at the Clínicas Integradas of the Evangelical Faculty of Paraná. Methods: sixty-eight patients (age 67 ± 6.5 years; FEV1 38.9 ± 16.2 predicted) were randomised to inhale 3% hypertonic saline (n=34) or placebo (n=34), combined with a program of exercise, three times a week, for 8-weeks. Results: After the 8-weeks the treatment period, both groups showed significant changes in functional exercise capacity (p<0,001), dyspnoea (p<0,001) and quality of life. When compared both groups, there was a significant improvement in placebo group in functional exercise capacity (p<0,001). Conclusion: the present study concluded that inhaling HS reduces the functional capacity, compared to placebo and being associated with the appearance of coughs and bronchial spasms.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with COPD diagnosis based on clinical findings and spirometry (FEV1 < 60% predict) according to American Thoracic Society20 clinically stable for at least the last month
- •aged between 40 and 75 years old
- •ex-smokers
- •without severe and/or unstable heart disease or any other pathologic conditions that could impair physical activities (e.g., cerebrovascular diseases and rheumatism), were included.
- •Respiratory medication was permitted, prior and throughout the duration of the study, such as bronchodilators and corticosteroids.
排除标准
- •Patients with unstable lung disease (as evidenced by the administration of intravenous antibiotics for four weeks before screening)
- •evidence of reactive airways (FEV1 ≥ 20 percent response to bronchodilatation or clinical diagnosis of asthma) were excluded
结局指标
主要结局
Functional exercise capacity
时间窗: measured by the 6-minute walking distance (6MWD) test
次要结局
- Dyspnoea(measured by the Medical Research Council dyspnoea score)