NCT04663386终止不适用
Switch of Budesonide-formoterol Dry Powder Inhalers at Pharmacy in Norway; A Retrospective, Observational Study to Evaluate the Impact on Disease Control in Patients With Asthma and/or Chronic Obstructive Pulmonary Disease (COPD)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Disease control
研究概览
简要总结
This is a retrospective, multicentre, non-interventional, observational study in patients with asthma and/or COPD who are treated with budesonide-formoterol.
详细描述
In July 2018 Norwegian authorities decided to allow switch at pharmacy for dry powder inhalers (DPIs) containing budesonide-formoterol. Pharmacists are instructed to switch patients to the inhaler with the lowest price. The pharmacist will train the patient on how to use the new inhaler. All patients whose eligible inhaler switch occurred between 1st July 2018 and 1st March 2019 will be eligible for the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent has been obtained.
- •Male or female patients with a diagnosis of asthma and/or COPD whose budesonide-formoterol DPI was switched to another budesonide-formoterol DPI at pharmacy between 1st July 2018 and 1st March 2019 (referred to as the eligible switch).
- •Age ≥12 years at time of switch.
- •Treated with budesonide-formoterol for at least 12 months before the eligible switch (pre-switch period) and 12 months after the eligible switch (post-switch period). Re-switch(es) of inhaler are allowed during the post-switch period.
排除标准
- •Patient has declined participation in the study or failed to respond to the invitation to participate.
结局指标
主要结局
Disease control
时间窗: 24 months
The number of asthma and/or COPD exacerbations during the 12 months pre-switch and the 12 months post-switch.
次要结局
- Budesonide-formoterol dose(24 months)
- Training at pharmacy(24 months)
- Healthcare utilisation(24 months)
- Inhaler switch(24 months)
研究者
研究点 (1)
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