EUCTR2007-003655-36-BE进行中（未招募）不适用
A randomized, double-blind, placebo controlled, multicentre study to determine the effect of QVA149 on lung function in patients with Chronic Obstructive Pulmonary Disease (COPD)
ovartis Pharma0 个研究点目标入组 140 人开始时间: 2008年1月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
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 according to the GOLD Guidelines 2006
- •Patients who have smoking history of at least 10 pack years.
- •Patients with a post-bronchodilator FEV1 =30% and < 80% of the predicted normal and post-bronchodilator FEV1/FVC <0.70.
- •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 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 urine pregnancy test.
- •Patients requiring long term oxygen therapy (> 15h a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency department for a COPD exacerbation of their airways disease in the 6 weeks prior to Visit 1 or during the run-in period.
- •Patients with any history of asthma
- •Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1. Patients who develop a respiratory tract infection during the screening period (up to Visit 3) must discontinue from the trial, but will be permitted to re-enroll at a later date (at least 6 weeks after the resolution of the respiratory tract infection).
- •Patients with any history of asthma indicated by but not limited to a blood eosinophil count > 400/mm3.
- •Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) unstable ischemic heart disease, left ventricular failure, long term prednisone therapy, history of myocardial infarction, arrhythmia (excluding stable AF), uncontrolled hypertension, narrow-angle glaucoma, symptomatic prostatic hyperplasia, clinically significant elevated PSA levels at screening, bladder-neck obstruction or moderate to severe renal impairment, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state or any condition which might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study.
- •History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
- •Patients with a history of long QT syndrome or whose QTc interval (Fridericia method) measured at Visit 2 is prolonged (>440 ms for males or >460 for females).
- •Treatments for COPD and allied conditions: the following medications should not be used between Visits 1 and 18. The minimum washout prior to Visit 2 is specified below:
- •The long acting anticholinergic agent tiotropium (bromide): 7 days.
- •Short acting anticholinergics: 8 h.
- •Fixed combinations of beta 2-agonists and inhaled corticosteroids: 48 h.
- •(Patients taking fixed dose combinations of ß2 agonisists and inhaled corticosteroids must be switched to the equivalent inhaled corticosteroid as monotherapy plus salbutamol/albuterol as rescue therapy at least 48 hours before Visit 2)
- •Long-acting beta 2-agonists: 48 h.
- •Short acting beta 2-agonists (other than those prescribed in the study): 6 hours.
- •Theophylline (any formulation): 7 days
- •NOTE: During the screening period and the 7 day washout periods administration of a fixed combination of a ß2-agonist and inhaled muscarinic antagonist is acceptable if deemed appropriate by the investigator. At no other time during the study will this regimen be acceptable. A minimum of 8 hours washout prior to visit assessments is mandatory.
研究者
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