A Real-world Non-interventional Study to Assess Patient Satisfaction With and Preference for Re-usable Respimat Soft Mist Inhaler in Patients With Chronic Obstructive Pulmonary Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 262
- 试验地点
- 20
- 主要终点
- Mean Total Patient Satisfaction and Preference Questionnaire (PASAPQ) Score
研究概览
简要总结
The study is to assess patient satisfaction with the inhaler attributes of the re-usable Respimat SMI (Spiriva, Striverdi or Spiolto) in patients with COPD, including patients who are Respimat SMI-experienced and Respimat SMI-naïve. This study also aims to examine patient preference for the re-usable Respimat SMI compared to the disposable Respimat SMI in Respimat SMI-experienced patients switching from a disposable to a re-usable Respimat SMI product at study entry.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients fulfilling all the following inclusion criteria will be eligible for participation in the study:
- •Provision of signed informed consent prior to study data collection
- •Patient with COPD aged 40 years or older
- •Patient prescribed (or already receiving the disposable Respimat SMI and switched to) one of the following re-usable Respimat SMI products per the standard clinical practice: Spiriva 2.5 microgram inhalation solution; (2) Striverdi 2.5 microgram inhalation solution; and (3) Spiolto 2.5 microgram / 2.5 microgram inhalation solution
- •Patient unlikely to change their Respimat therapy during the 4-6 week observation period (in the opinion of the investigator)
排除标准
- •Patients fulfilling any of the following exclusion criteria will not be eligible for participation in the study:
- •Patient using a disposable Respimat SMI product during the study period
- •Patient who have had a severe COPD exacerbation requiring hospitalisation in the immediate 3 months prior to study entry
- •Patient participating in a clinical trial or any other non-interventional study of a drug or device at the time of enrolment
- •Visual, cognitive, motor or health impairment that, as judged by the investigator, may cause concern regarding the patient's ability to complete the questionnaires
- •Patient not fluent and literate in one of the main languages of the country
研究组 & 干预措施
Respimat SMI-experienced: Switching to re-usable Respimat
patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry.
干预措施: Respimat (Drug)
Respimat SMI-naïve
patients who have not previously used a Respimat SMI product and receive their first prescription at study entry
干预措施: Respimat (Drug)
结局指标
主要结局
Mean Total Patient Satisfaction and Preference Questionnaire (PASAPQ) Score
时间窗: At follow-up assessment, 4 to 6 weeks after baseline.
Total PASAPQ score is a measure of patient's satisfaction regarding the handling of the re-usable Respimat® SMI. The total score was the sum of the 13 items related to Performance and Convenience PASAPG domains (7 items for Performance domain: Q 1-5, 10-11, and 6 items for convenience domain: Q6-9, 12-13). Each PASAPQ item had response options ranging from 1 (very dissatisfied) to 7 (very satisfied). To calculate the total and domain score, the items within each domain were first summed and then transformed to a 0 (least) or 100 (most) point scale, with higher scores indicating greater satisfaction: Performance score = 100 \*\[(Q1+Q2 +Q3+ Q4+Q5+Q10+Q11)-7\] /(49-7) Convenience score = 100 \*\[(Q6+ Q7+Q8+Q9+Q12+Q13)-6\] / (42-6) Total score = 100 \*\[(Q1+Q2 +Q3+Q4+ Q5+Q6 + Q7+Q8+ Q9+Q10+Q11+Q12+Q13)-13\] / (91-13)
次要结局
- Number of Patients With Preference for Re-usable or Disposable Respimat SMI at Study End in Respimat SMI-experienced Patients Who Switched From a Disposable to a Re-usable Respimat SMI Product(At follow-up assessment, 4 to 6 weeks after baseline.)
- Question on Willingness to Continue With Inhaler for All Patients at Study End (Follow-up Assessment)(At follow-up assessment, 4 to 6 weeks after baseline.)
- Overall Satisfaction Question With Inhaler for All Patients at Study End (Follow-up Assessment)(At follow-up assessment, 4 to 6 weeks after baseline.)
- Questions on Ease of Handling of the Re-usable Respimat SMI for All Patients at Study End (Follow-up Assessment)(At follow-up assessment, 4 to 6 weeks after baseline.)
- Total Performance PASAPQ Score for All Patients at Study End (Follow-up Assessment)(At follow-up assessment, 4 to 6 weeks after baseline.)
- Total Convenience PASAPQ Score for All Patients at Study End (Follow-up Assessment)(At follow-up assessment, 4 to 6 weeks after baseline.)
- Difference in the Mean Total PASAPQ Score Between Study Entry and Study End in Respimat SMI-experienced Patients Who Switched From a Disposable to a Re-usable Respimat SMI Product(At study entry (baseline) and at study end (4 to 6 weeks after baseline).)