EUCTR2012-003346-32-PL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
- •1. Patients who have signed an Informed Consent Form prior to initiation of any studyrelated
- •2. Male and female adults aged =40 years.
- •3. Patients with stable COPD according to the current GOLD strategy.
- •4. Patients with airflow limitation indicated by a post-bronchodilator FEV1 = 30% and <80% of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70 at run-in (Visit 101). Post-bronchodilator refers to 1 hour after sequential inhalation of 84 µg ipratropium bromide (or equivalent dose) and 400 µg salbutamol (or 360 µg albuterol). Spacer devices are not permitted during reversibility testing.
- •5. Current or ex-smokers who have a smoking history of at least 10 pack years (e.g.10 pack years = 1 pack /day x 10 years, or ½ pack/day x 20 years). An ex-smoker may be defined as a subject who has not smoked for = 6 months at screening.
- •6. Patients with an mMRC grade 2 or greater at Visit 101.
- •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
- •1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG (human Chorionic Gonadotropin) laboratory test.
- •2. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. Effective contraception methods are described in the protocol3. Patients with Type I or uncontrolled Type II diabetes.
- •3. Patients with Type I or uncontrolled Type II diabetes.
- •4. Patients with a history of long QT syndrome or whose QTc measured at Visit 101 (Fridericia method) is prolonged (>450 ms for males and females) and confirmed by a central assessor. These patients should not be re-screened.
- •5. Patients who have a clinically significant ECG abnormality at Visit 101 or Visit 102. (These patients should not be re-screened)
- •6. Patients who have a clinically significant laboratory abnormality at Visit 101.
- •7. Patients with a body mass index (BMI) of more than 40 kg/m2.
- •8. Patients who have clinically significant renal, cardiovascular (such as but not limited to unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, myocardial infarction), arrhythmia (see below for patients with atrial fibrillation), neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of the efficacy and safety of the study treatment.
- •9. Patients with paroxysmal (e.g. intermittent) atrial fibrillation are excluded. Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., selective beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at Visit 101 and Visit 102 visits with a resting ventricular rate < 100/min. At Visit 101 the atrial fibrillation must be confirmed by central reading.
- •10. Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof:
- •anticholinergic agents
- •long and short acting beta-2 agonists
- •sympathomimetic amines
- •lactose or any of the other excipients of trial medication
- •For the full list of exclusion criteria, please refer to the protocol.
研究者
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