A 1-year Multi-center, Prospective, Cohort Study in Patients With Chronic Obstructive Pulmonary Disease Treated With Long-acting Bronchodilator
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,229
- 试验地点
- 1
- 主要终点
- Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
研究概览
简要总结
This multi-center study is designed to describe natural history of disease, treatment and health care products in physician-diagnosed COPD patients who require adding daily maintenance therapy in real world.
The study planned to enroll 550 patients in Indacaterol group and 9450 patients in non- Indacaterol group, a total of 10,000 patients. Enrollment was stopped at 2253 patients due to low recruitment in indacaterol group. Finally a total of 2229 patients were analyzed in full analysis set.
A total of 2253 patients entered into the database, of which 24 patients were exclude during the data review meetings, because they did not met the inclusion/exclusion criteria. Hence a total of 2229 patients enrolled successfully.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide informed consent
- •Physician-diagnosis of COPD
- •COPD patients requiring long-acting bronchodilator treatment
- •Patients with spirometry available at baseline
排除标准
- •Patients who have a diagnosis of asthma.
- •Patients who had been hospitalized for a COPD exacerbation in the 4 weeks prior to Visit
- •Current clinical diagnosis of other chronic respiratory illnesses
- •Concurrent participation in a clinical trial or use of an investigational drug.
- •Active malignancy or history of malignancy of any organ system
- •Pregnant or nursing (lactating) women
- •Women of child-bearing potential with no contraception Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Oral theophylline
干预措施: theophylline based treatment (Drug)
Other treatment
non-long-acting bronchodilators for COPD treatment, such treatments were classified as "other treatments"
干预措施: Other treatment (Drug)
结局指标
主要结局
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
时间窗: Baseline,3 months
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. A positive change from baseline in FEV1 indicates improvement in lung function. Pulmonary function tests were performed at study visits including FEV1, and Force Vital Capacity (FVC). These were performed 30 minutes before treatment and not more than 2 hours in advance after stopping the Long-acting bronchodilators eight hours before visits. In order to reduce the variation between each test, the same instrument was used in the whole research process if condition allowed.
次要结局
- Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)(Baseline,12 months)
- COPD Exacerbation(Baseline,12 months)
- Change in Health Status Questionnaire MMRC(Baseline,3,6,9,12 months)
- Change From Baseline in Questionnaire COPD Assessment Test (CAT) Score(Baseline,3,6,9,12 months)
- Change From Baseline Questionnaire Transition Dyspnea Index (TDI) Score(Baseline,3,6,9,12 months)