EUCTR2011-000229-63-DE进行中（未招募）不适用
A multicenter, randomized, blinded, double-dummy, placebo controlled, 3-period cross-over study to evaluate the effect of QVA149 on patient reported dyspnea in moderate to severe chronic obstructive pulmonary disease (COPD), using tiotropium as an active control
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 234
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 or female adults aged =40 years, who have signed an Informed Consent Form prior
- •to initiation of any study-related procedure.
- •- Patients with moderate to severe stable COPD (Stage II or Stage III) according to the GOLD Guidelines 2009.
- •- Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten packyears are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.)
- •- Patients with a post-bronchodilator FEV1 =30% and < 80% of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7 at Visit 2 (Day -14).
- •- mMRC grade of at least 2 at Visit 2.
- •- Patients with ability to use the computer mouse and navigate the computer display.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy
- •- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use effective contraception during the study. UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea, OR 6 weeks after surgical bilateral oophorectomy (with or without hysterectomy).
- •- Patients with a history of long QT syndrome or whose QTc measured at Visit 2 (Day -14) (Fridericia method) is prolonged (>450 ms for males and females) as confirmed by the central ECG assessor.
- •- Patients who have a clinically significant abnormality on the ECG at Visit 2, who in the judgment of the investigator would be at potential risk if enrolled into the study.
- •- Patients with Type I or uncontrolled Type II diabetes
- •- Patients who have not achieved spirometry result at Visit 2 in accordance with ATS/ERS criteria for acceptability and repeatability.
- •- Patients with narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention.
- •-Patients with a history of malignancy of any organ system
- •-Patients requiring long term oxygen therapy (> 15 h a day) on a daily basis for chronic
- •-Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the 6 weeks prior to screening (Visit 1 or between Visit 1 and Visit 3).
- •-Patients who develop a COPD exacerbation between the pre-screening and the randomization visit (Visits 1 and 3) will not be eligible but will be permitted to be rescreened after a minimum of 6 weeks after the resolution of the COPD exacerbation.
- •-Patients who have had a respiratory tract infection within 6 weeks prior to pre-screening
研究者
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