NCT00274573已完成3 期
Acute and Long-term Effects of Once Daily Oral Inhalation of Tiotropium 18 Mcg Dry Powder Inhalation Capsules in a Placebo Controlled Parallel Group Design Study in Patients With Chronic Obstructive Pulmonary Disease (COPD) of Different Severity
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,639
- 试验地点
- 177
- 主要终点
- Change from baseline in trough FEV1 (Forced expiratory volume in one second)
研究概览
简要总结
The primary objective of this study is to investigate the effect of tiotropium vs. placebo on trough FEV1 and FEV1 2 hours post inhalation after 12 weeks of treatment. For both endpoints changes from baseline will be analysed. Three strata of patients will be included (severe COPD, i.e. <35% of predicted FEV1, moderate COPD, i.e. 35% - <50% of predicted FEV1, mild COPD, i.e. 50% - 70% of predicted FEV1, according to American Thoracic Society [ATS] criteria). The study is conducted in order to find out for which endpoint tiotropium is different from placebo in which stratum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
- •Patients must have relatively stable, mild to severe airway obstruction with an FEV1 =<70% of predicted normal and an FEV1/FVC < 70 %.
- •Predicted normal values will be taken from the print-outs of the spirometers. Spirometers have to calibrated according to ECCS.
- •Male or female patients 40 years of age or older.
- •Patients must be current or ex-smokers with a smoking history of 10 or more than 10 pack-years. Pack Years = Number of cigarettes/day : 20 x years of smoking (Patients who have never smoked cigarettes must not be included)
- •Patients must be able to perform all study related tests, acceptable pulmonary function tests, including Peak Expiratory Flow Rate (PEFR) measurements, and must be able to maintain diary cards during the study period as required in the protocol.
- •Patients must be able to inhale medication from the HandiHaler.
- •All patients must sign an Informed Consent Form prior to participation in the trial i.e. prior to pre-study washout of their usual pulmonary medications.
排除标准
- •Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
- •Patients with a recent history (i.e., one year or less) of myocardial infarction.
- •Patients with any cardiac arrhythmia requiring drug therapy or who have been hospitalised for heart failure within the past three years.
- •Patients who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy.
- •Patients with known active tuberculosis.
- •Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed.
- •Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis.
- •Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion
- •Patients with any respiratory infection in the past six weeks prior to the Screening Visit (Visit 1) or during the run-in period.
- •Patients who are currently in a pulmonary rehabilitation programme or who have completed a pulmonary rehabilitation programme in the six week prior to the Screening Visit (Visit 1).
- •Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system.
- •Patients with known symptomatic prostate hypertrophy or bladder neck obstruction.
- •Patients with known narrow-angle glaucoma.
- •Patients using oral corticosteroid medication at unstable doses (i.e., less than four weeks on a stable dose before Visit 1) or at doses in excess of the equivalent of 10 mg of prednisolone per day or 20 mg every other day.
- •Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e. oral contraceptives, intrauterine devices, diaphragm or subdermal implants).
- •Patients with a history of asthma, allergic rhinitis or atopy.
- •Patients with a history of and/or active significant alcohol or drug abuse.
- •Patients who have taken an investigational drug within one month prior to Screening Visit (Visit 1). A log of all subjects screened, and reasons for exclusion for those not randomised will be maintained.
结局指标
主要结局
Change from baseline in trough FEV1 (Forced expiratory volume in one second)
时间窗: after 12 weeks
Change from baseline in FEV1 2 hours post inhalation
时间窗: after 12 weeks
次要结局
- Duration of COPD exacerbations per patient(12 weeks)
- Duration of hospitalisations due to a COPD exacerbation(12 weeks)
- Change from baseline in FVC (Forced Vital Capacity) 2 hours post inhalation(Day 1 and 85)
- Change from baseline in IVC (Inspiratory Vital Capacity) 2 hours post inhalation(Day 1 and 85)
- Number of patients having a COPD exacerbation(12 weeks)
- Number of patients being hospitalised due to a COPD exacerbation(12 weeks)
- Number of COPD exacerbations per patient(12 weeks)
- Number hospitalisations due to COPD exacerbations per patient(12 weeks)
- Change from baseline in FEV1 2 hours post inhalation(Day 1)
研究者
研究点 (177)
Loading locations...
相似试验
已完成
2 期
An Efficacy and Safety Evaluation of Tiotropium add-on Therapy in Patients With Severe Persistent AsthmaAsthmaNCT00365560Boehringer Ingelheim115
已完成
3 期
A Study to Determine the Effect of Tiotropium + Olodaterol Fixed Dose Combination on Exercise Endurance Time During Constant Work Rate Cycle Ergometry Test in COPDPulmonary Disease, Chronic ObstructiveNCT01525615Boehringer Ingelheim404
已完成
4 期
Efficacy and Safety of Tiotropium in Patients With COPD and Concomitant Diagnosis of AsthmaPulmonary Disease, Chronic ObstructiveAsthmaNCT00152984Boehringer Ingelheim472
已完成
3 期
Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease IIPulmonary Disease, Chronic ObstructiveNCT00796653Boehringer Ingelheim937
已完成
3 期
Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease IPulmonary Disease, Chronic ObstructiveNCT00793624Boehringer Ingelheim906