The Effect of Escitalopram on Exacerbation Rates and Quality of Life in Patients With Anxiety Associated With Severe COPD
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- exacerbation rate
研究概览
简要总结
Anxiety and depression are common in patients with severe chronic obstructive pulmonary disease (COPD). Frequently exacerbation's of breathlessness are associated with panic/fear and indeed this may be the main cause for the for hospital admission. Patients prone to a tendency to experience and communicate somatic distress in response to psychosocial stress and to seek medical help for it are top of the "frequent flyer" league, costing the health care economy dearly. This is a particular problem in Hull with the high levels of smoking and urban deprivation combining to place the city at the bottom of the Department of Health COPD league tables.
Our hypothesis is that an effective treatment for anxiety will reduce the number of episodes of hospital admission by reducing the panic/fear element of mild COPD exacerbation's thus allowing the patient time to access the existing community based support services.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/females aged between 40-80 years.
- •Previous diagnosis of COPD confirmed by the GOLD criteria.
- •At least two previous admissions to hospital for acute exacerbation of COPD.
- •Physician diagnosed anxiety
- •At least Mild anxiety score on HADS and GAD-7
- •On a stable therapeutic regimen for COPD for 8 weeks prior to inclusion
- •Known history of cigarette smoking at least 10 pack yrs
- •Willing and able to comply with study procedures
- •Able to provide written informed consent to participate
排除标准
- •Current or past diagnosis of asthma
- •Long-term oxygen therapy
- •Currently on treatment with anti-depressives
- •Serious inter-current illness (eg lung cancer)
- •One year survival considered unlikely
- •Patients who have evidence of alcohol or drug abuse
- •Participation in another clinical trial with an investigational drug in four weeks preceding the screening visit
- •Clinically significant or unstable concurrent disease e.g. left ventricular failure, diabetes mellitus
- •Known or suspected hypersensitivity to escitalopram
研究组 & 干预措施
escitalopram
escitalipram tablets 5mg, 10 mg and 20 mg, once a day for 12 months
干预措施: escitalopram (Drug)
结局指标
主要结局
exacerbation rate
时间窗: 12 months
comparison of the rate of COPD exacerbation in the year preceding treatment with that on escitalopram treatment in patients with COPD adjudged to have a significant element of anxiety.
次要结局
- BODE index(12 months)
- Spirometry(12 months)
- Modified Medical Research Council (MMRC) dyspnoea scale(12 month)
- Quality of life(12 months)
- Hospital Anxiety and depression scale (HADS)(12 months)
- General anxiety disorder(GAD-7)(12 months)
- Health related utilisation(12 months)
研究者
Prof A H Morice
professor of Respiratory Medicine
Hull University Teaching Hospitals NHS Trust