Switching COPD Patients From Spiriva® HandiHaler® Maintenance Therapy to Spiriva® Respimat®: a Non-Interventional Real-world clinicAl ouTcome assEssment: NIS PIRATE
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of Participants With 0.2 Points Decrease in the Clinical COPD Questionnaire (CCQ) Score Between Baseline and Visit 2 in Patients With High CCQ Baseline Score (≥ 2)
研究概览
简要总结
The objective of this non-interventional, observational study is to assess whether changing Chronic Obstructive Pulmonary Disease (COPD) patients from a dry powder inhaler (HandiHaler®) to a soft mist inhaler (Respimat®), without changing the pharmacological compound, will lead to an improvement in Clinical COPD Questionnaire (CCQ) score and in the scores of the three subdomains of CCQ score: symptoms (4 items), functional state (4 items) and mental state (2 items) during a study period of approximately 8 weeks.
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
- •Participants ≥ 40 years of age at baseline visit
- •Patients with confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
- •Patients who have been on Spiriva® HandiHaler® for ≥ 6 weeks at baseline visit
- •Patients for whom a switch from Spiriva® HandiHaler® to Spiriva® Respimat® was planned prior to study inclusion. If additional inhalative COPD drugs (AICDs) are used: AICD treatment must have been stable for at least 6 weeks before study inclusion
- •Signed written informed consent form to participation
排除标准
- •Patients who have contraindications to Spiriva® Respimat® according to the current prescribing information label/ summary of product characteristics (SmPC)
- •Patients who have signs of a current, acute respiratory tract infection 2 weeks prior visit 1
- •Patients for whom further follow-up will not be possible at the enrolling site during the planned observational period (of approximately 8 weeks)
- •Patients with confirmed diagnosis of only asthma
- •Patients who had > 1 moderate to severe exacerbation(s) within the last 6 weeks prior to study inclusion
- •Patients who are pregnant or breastfeeding
- •Patients participating in an ongoing interventional study
研究组 & 干预措施
Patients switching from Spiriva® HandiHaler® to Spiriva® Respimat®
干预措施: Spiriva® Respimat® (Device)
Patients switching from Spiriva® HandiHaler® to Spiriva® Respimat®
干预措施: Spiriva® HandiHaler® (Device)
Patients switching from Spiriva® HandiHaler® to Spiriva® Respimat®
干预措施: Tiotropium bromide (Drug)
结局指标
主要结局
Number of Participants With 0.2 Points Decrease in the Clinical COPD Questionnaire (CCQ) Score Between Baseline and Visit 2 in Patients With High CCQ Baseline Score (≥ 2)
时间窗: Baseline and at Week 8.
Number of participants with 0.2 points decrease in the Clinical COPD Questionnaire (CCQ) score between baseline and visit 2 in patients with high CCQ baseline score (≥ 2) is reported. The CCQ contains 10 questions about symptoms (items 1, 2, 5, 6 of the CCQ), functional status (CCQ-4, items 7, 8, 9 and 10 of the CCQ) and mental state (items 3, 4 of the CCQ). Each of the 10 CCQ questions is scored by the patient on a 7-point scale (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. CCQ score values can be interpreted as: acceptable (CCQ \< 1); acceptable for moderate disease (1 ≤CCQ \<2); instable-severe limited (2 ≤ CCQ \< 3); very instable-very severe limited (CCQ ≥ 3).
次要结局
- Changes in Clinical Control: Mean Change in the CCQ Score and in the Scores of the 3 CCQ Subdomains Symptom, Mental State, and Functional State Domain, in All Patients Independently From CCQ Baseline Score(Baseline and at Week 8.)
- Changes in Clinical Control: Mean Change in the CCQ Score and in the Scores of the 3 CCQ Subdomains Symptom, Mental State, and Functional State Domain, in Patients With High CCQ Baseline Score (≥ 2)(Baseline and at Week 8.)
- Number of Participants With 0.2 Points Decrease in the CCQ Score Between Baseline and Visit 2 in Patients Independently From CCQ Baseline Score(Baseline and at Week 8.)
- Breathlessness of the Patients at Baseline and at Week 8(At baseline and at Week 8.)
- Changes in Breathlessness of the Patients From Baseline to Week 8(At baseline and at Week 8.)