Post-Marketing Observational Study of the Impact of Adherence to Treatment With Once-Daily Administered Long-Acting Bronchodilators (LABAs / LAMAs) on Patients Health Related Quality of Life in COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 645
- 试验地点
- 1
- 主要终点
- CCQ Total Score at Month 13 (Visit 4)
研究概览
简要总结
The objective of the study is to observe the effect of adherence to once-daily administered long-acting bronchodilators (long-acting ß2-agonists [LABAs] / long-acting muscarinic antagonists [LAMAs]) on patients health related quality of life (HR-QoL) and to assess the relation between symptoms improvement and adherence to Chronic Obstructive Pulmonary Disease (COPD) maintenance therapy
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
LAMA/LABA Patients
干预措施: Tiotropium 2x2.5µg tiotropium (equivalent to 2x3.154µg tiotropium bromide monohydrate) Respimat® inhaler and cartridge Solution for inhalation (Drug)
LAMA/LABA Patients
干预措施: Indacterol 300 µg (Drug)
LAMA/LABA Patients
干预措施: Tiotropium 18µg (equivalent to 22.5µg tiotropium bromide monohydrate) HandiHaler® device Inhalation powder, hard capsule (Drug)
LAMA/LABA Patients
干预措施: Indacterol 150 µg (Drug)
结局指标
主要结局
CCQ Total Score at Month 13 (Visit 4)
时间窗: 13 months
Mean and standard deviation of CCQ total score is presented at month 13.
Number of COPD Exacerbations Leading to Hospitalization, Per Patient
时间窗: 13 months
Percentage of subjects hospitalized due to COPD exacerbations exactly "n" number of times during the study period is presented. Here, "n" represents the number of times each subject is hospitalized due to COPD exacerbations.
Clinical COPD Questionnaire (CCQ) Total Score Change From Baseline at Month 13
时间窗: Baseline and 13 Month
The Clinical COPD (Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) is a standardized, validated and reliable questionnaire (in local language) to assess the impact of treatment on health status in COPD patients. CCQ total score is calculated as the arithmetic average of 10 individual scores on a 7-point scale. CCQ total score varies from 0 (very good control) to 6 (extremely poor control). Mean change in CCQ total score from baseline at month 13 is presented along with its standard error. Change in CCQ total score is calculated for each subject as: CCQ total score at month 13 - CCQ total score at baseline. Baseline is defined as the first assessment after enrolment (at Month 1).
Number of COPD Exacerbations, Per Patient
时间窗: 13 months
Percentage of subjects experienced COPD exacerbations exactly "n" number of times during the study period is presented. Here, "n" represents the number of times each subject experienced COPD exacerbations.
次要结局
- Reasons of Non-adherence to Once-daily Long-acting Bronchodilators in COPD Patients(13 months)
