CTRI/2012/12/003207已完成3 期
A Placebo and Active Controlled Study to Assess the Long-term Safety of Once Daily QVA149 for 52 Weeks in Chronic Obstructive Pulmonary Disease (COPD) Patients With Moderate to Severe Airflow Limitation - RADIATE
ovartis Healthcare Pvt Ltd0 个研究点目标入组 1,224 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,224
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Smoking history of at least 10 pack years
- •2.Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate to severe airflow limitation as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2011)
- •3.Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)less then 80 percent and greater than equal to 30percent of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) less than 70percent.
- •4.Modified Medical Research Council questionnaire grade of 2 or higher
排除标准
- •1.Patients who have had a respiratory tract infection within 4 weeks prior to visit 1
- •2.Patients with concomitant pulmonary disease.
- •3.Patients with a history of asthma.
- •4.Any patient with lung cancer or a history of lung cancer
- •5.Patients with a history of certain cardiovascular co-morbid conditions.
- •6.Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency.
- •7.Patients contraindicated for inhaled anticholinergic agents and β2 agonists.
- •8.Patients in the active phase of a supervised pulmonary rehabilitation program.
研究者
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