sTep dOWn Inhalers in the reAl woRlD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Numbers maintained on dual bronchodilation
研究概览
简要总结
To establish the feasibility of stopping inhaled steroids and switching or maintaining dual bronchodilation in one visit - in the real world, for people with COPD.
详细描述
COPD patients prescribed a combination of any inhaled corticosteroid (ICS), long acting beta agonist (LABA) and long acting muscarinic antagonist (LAMA) will be switched to a single LABA/LAMA combination inhaler, stopping their ICS. They will be followed up for 12 months.
Participants are shown the four currently available LABA/LAMA combination inhalers and instructed on their use. The clinical specialist will use standard prompts in an effort to demonstrate the inhalers in an unbiased way. The participants will choose: Ultibro® (Breezhaler device) or Duaklir® (Genuair device) or Anoro® (Ellipta device) or Spiolto® (Respimat device) and they will be prescribed the inhaler of their choice provided they can demonstrate effective use.
Patients will be reviewed 4, 12, 26 and at 52 weeks after switching with clinical outcomes measured at these points. As this is a real-world open study the patients and GPs are instructed that treatments can be changed at any point as clinically indicated, including restarting an ICS.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GP diagnosis of COPD
- •Post bronchodilator FEV1/FVC ratio <70% with FEV1<80% predicted
- •Current or ex smoker equal or greater than 10 pack years
- •Taking an ICS, LABA & LAMA
排除标准
- •Unable or unwilling to sign informed consent
- •Any previous or current diagnosis of asthma
- •Any features of asthma or large variability in symptoms
- •History of atopy
- •Any previous blood eosinophil count >600mm3
- •A moderate or severe exacerbation of COPD (needing systemic glucocorticosteroids or hospital admission for >24 hours) within the last 6 weeks
- •Life expectancy < 1 year
研究组 & 干预措施
LABA/LAMA inhaler
Patients on a combination of inhaled corticosteroid (ICS), long acting beta agonist (LABA) and long acting muscarinic antagonist (LAMA) will be taken off their current ICS/LABA/LAMA combination inhalers and will commence on a single LABA/LAMA inhaler (any LABA/LAMA) of their choice.
干预措施: Any LABA/LAMA (Drug)
结局指标
主要结局
Numbers maintained on dual bronchodilation
时间窗: At 12 months
The proportion of patients with stable COPD who can be successfully switched from triple inhaled therapy (ICS+LABA+LAMA in any combination of inhalers) to dual inhaled bronchodilator therapy (LABA+LAMA)
次要结局
- Exacerbations(12 months before and 12 months after enrollment)
- Lung function(Baseline, 4 weeks, 12 weeks, 26 weeks, 52 weeks)
- COPD assessment test (CAT)(Over 12 months)
- EQ-5D-3L(Over 12 months)
- Moderate or severe exacerbations(12 months before and 12 months after enrollment)
- Costs(12 months before and 12 months after enrollment)
- Restarting inhaled steroids(At 12 months)
- Inhaler device choice(At enrollment)