EUCTR2012-003347-30-HU进行中（未招募）不适用
A 12-week treatment, multi-center, randomized, double-blind, parallel group, placebo and active controlled study to assess the efficacy, safety, and tolerability of QVA149 (indacaterol maleate /glycopyrronium bromide) in COPD patients with moderate to severe airflow limitation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male and female patients that have signed informed consent and are >/= 40 years of age.
- •Patients with stable Chronic Obstructive Pulmonary Disease (COPD) according to GOLD 2011.
- •Patients with a post-bronchodilator Force Expiratory Volume in one second (FEV1) of >/= 30% and < 80% predicted and a post-bronchodilator FEV1/ Forced Vital capacity (FVC) <0.70.
- •Current or ex-smokers who have a smoking history of at least 10 pack years.
- •Patients with an mMRC grade 2 or greater.
- •Other protocol defined inclusion criteria may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 520
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 480
排除标准
- •Patients contraindicated for muscarinic antagonist agents and beta-2 agonists.
- •Patients with a history of malignancy of any organ system, treated or untreated, within the last five years.
- •Patients with narrow-angle glaucoma, Benign Prostatic Hyperplasia (BPH) or bladder-neck obstruction or moderate-severe renal impairment or urinary retention.
- •Patients who had a COPD exacerbation within 6 weeks prior to screening.
- •Patients who have a respiratory tract infection within 4 weeks prior to screening.
- •Patients requiring long term oxygen therapy prescribed for more than 12 hour per day.
- •Patients with a history of asthma.
- •Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to age 40 years.
- •Patients with a blood eosinophil count of greater than 600 mm/3 during run-in.
- •Patients with concomitant pulmonary disease.
- •Patients with a history of certain cardiovascular co-morbid conditions
- •Patients with a diagnosis of alpha-1 anti-trypsin deficiency.
- •Patients with active pulmonary tuberculosis.
- •Patients in the active phase of a pulmonary rehabilitation programme.
- •Other protocol-defined exclusion criteria may apply.
研究者
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