Replacement of Nebulised Ipratropium With Inhaled Tiotropium in Stable COPD
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Spirometry
研究概览
简要总结
Some patients with chronic obstructive pulmonary disease (COPD) take nebulised treatments to ease the symptom of breathlessness, including the drug ipratropium. Nebulised bronchodilator drugs are taken up to 4 times through the day, and this can take up to 15 minutes each time. Although the treatment isbe effective, patients report that the time taken to set-up and use the nebuliser can be a disincentive to regular use. By contrast, an inhaler device is easy to use following appropriate instruction, and takes only a few seconds to administer. Inhaled tiotropium is a once daily treatment taken by inhaler which has been shown to be effective in COPD. We wish to assess whether inhaled Tiotropium as effective as nebulised ipratropium in patients with stable chronic obstructive pulmonary disease.
详细描述
Tiotropium and ipratropium bromide are both antimuscarinic bronchodilators, licensed for the treatment of COPD with a similar side-effect profile. Tiotropium administered by an inhaler device (Handihaler®) has been shown to be superior to placebo and inhaled ipratropium bromide in patients with COPD, in both short term and longer term studies. The superiority of inhaled tiotropium over inhaled ipratropium bromide has been demonstrated for lung function tests and also for measures of health status. It is not known however if inhaled tiotropium is superior to ipratropium bromide administered via a nebuliser.
We wish to examine whether inhaled tiotropium is as effective and safe as nebulised ipratropium bromide in patients with chronic stable COPD.
Design The study will be a randomised, crossover study. The patients will not be blinded to the therapy but the technician performing the pulmonary function tests will be blinded to the patients' therapy.
Duration The length of the study for each patient will be 12 weeks.
Patient group Patients would be recruited from the population of patients supplied with a nebuliser from the respiratory department at Glasgow Royal Infirmary. Patients will be identified from those regularly attending the out-patients department and who have stable disease. Patients who frequently admitted to the respiratory ward with exacerbations of their disease will be excluded. Patients will be recruited at the rate of 2 per week. The study will be a single site study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable Moderate to severe COPD (GOLD criteria)
- •> 20 pack year smoking history
- •current treatment with nebulised ipratropium bromide
- •no exacerbations within preceding 3 months
排除标准
- •current participation in other study
- •< 20 pack year smoking history
- •Significant co-morbidity e.g. cardiac
- •history of intolerance to lactose
结局指标
主要结局
Spirometry
次要结局
- Baseline/Transition Dyspnea index
- St George's Respiratory Questionnaire