A 12 Week, Multi-center, Randomized, Open Label Study, eValuating the Efficacy and Safety of Treatment Regimens That Include ONbrez (Indacaterol) in Patients With Moderate to Severe COPD (MOVE-ON Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change From Baseline on Clinical COPD Questionnaire (CCQ) Score
研究概览
简要总结
In this 12-week study, patients were randomized to either open-label indacaterol or standard of care for Chronic Obstructive Pulmonary Disease (COPD) treatment; efficacy and safety were assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:
- •Post-bronchodilator forced expiratory volume in 1 second (FEV1) <80% and ≥30% of the predicted normal value
- •Post-bronchodilator FEV1/FVC (Forced Vital Capacity) <70%
- •Current COPD bronchodilator treatment that includes a LABA bronchodilator or a fixed dose combination of LABA and Inhaled Corticosteroid (ICS)
排除标准
- •Patients with a history of asthma
- •Patients who are currently being treated for COPD with tiotropium (Spiriva®)
- •Patients with diabetes Type I or uncontrolled diabetes Type II
- •Patients with a history of certain cardiovascular comorbid conditions
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Indacaterol
Indacaterol 150 µg once-daily via single-dose dry powder inhaler
干预措施: Indacaterol (Drug)
Long-acting beta2-agonist
Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
干预措施: Long-acting beta2-agonist (Drug)
结局指标
主要结局
Change From Baseline on Clinical COPD Questionnaire (CCQ) Score
时间窗: Baseline and 12 weeks
The Clinical Chronic Obstructive Pulmonary disease (COPD) Questionnaire (CCQ) is a self-administered questionnaire containing ten questions, divided into three domains: symptoms, mental and functional state. The questions are based on a 7-point scale where a '0' means having no limitations and a '6' means extreme or complete limitations. The final score is the mean of all ten questions. The CCQ score was recalculated according to the paper by Van der Molen et al., 2003. The statistical significance remained the same.
次要结局
未报告次要终点