NCT00274560已完成3 期
A Multiple Dose Comparison of Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol in a 12 Week, Randomized, Double-Blind, Double-Dummy Parallel Group Study in Patients With Chronic Obstructive Pulmonary Disease (COPD).
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 653
- 试验地点
- 50
- 主要终点
- FEV1 area under the curve for the time period of 0 to 12 hours (FEV1 AUC0-12)
研究概览
简要总结
The objective of the study was to evaluate the degree of improvement in lung function in patients with chronic obstructive pulmonary disease (COPD) after treatment with tiotropium inhalation capsules compared to salmeterol inhalation aerosol .
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
- •Ability to sign a written Informed Consent Form consistent with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial (i.e., prior to any study procedures, including any pre-study washout of medications).
- •Age of 40 years or older.
- •Smoking history of ≥10 pack-years.
- •A diagnosis of relatively stable chronic obstructive pulmonary disease with an Forced expiratory volume in one second (FEV1) ≤60% of predicted normal and FEV1 ≤70% of Forced vital capacity (FVC).
- •Ability to perform technically acceptable pulmonary function tests, and ability to maintain records during the study period as required in the protocol.
- •Ability to inhale medication from the HandiHaler® and from a metered dose inhaler.
排除标准
- •Clinically significant diseases other than Chronic obstructive pulmonary disease (COPD). A clinically significant disease was defined as a disease or condition which, in the opinion of the investigator, could have put the patient at risk because of participation in the study or may have influenced either the results of the study or the patient's ability to participate in the study.
- •Known moderate or severe renal insufficiency.
- •A recent history (i.e., six months or less) of myocardial infarction.
- •Unstable or life-threatening cardiac arrhythmias, including newly diagnosed, clinically relevant arrhythmia on the electrocardiogram (ECG) performed on Visit
- •Unstable arrhythmias included arrhythmias that required an intervention (i.e., hospitalization, cardioversion, pacemaker placement, and automatic implantable cardiac defibrillator (AICD) placement) or a change in drug therapy during the year preceding study enrollment.
- •Hospitalization for heart failure during the past three years.
- •History of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.
- •Other exclusion criteria apply.
结局指标
主要结局
FEV1 area under the curve for the time period of 0 to 12 hours (FEV1 AUC0-12)
时间窗: 12 weeks
peak FEV1
时间窗: 12 weeks
次要结局
- Trough and peak FVC and FVC AUC0-12 measured at the same times as FEV1 on each test day(12 weeks)
- Number (%) of patients with at least one exacerbation of COPD(12 weeks)
- Individual FEV1 and FVC measurements at each timepoint(12 weeks)
- Trough FEV1: Trough FEV1 was the FEV1 measured prior to dosing(12 weeks)
- number of exacerbations(12 weeks)
- All adverse events(12 weeks)
- Pulse rate measured in conjunction with spirometry(12 weeks)
- time to first exacerbation(12 weeks)
- number of exacerbation days(12 weeks)
- Average daily occasions of rescue medication [albuterol (salbutamol)] use each week(12 weeks)
- Blood pressure (seated) measured in conjunction with spirometry(12 weeks)
研究者
研究点 (50)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of Tiotropium Compared to Salmeterol and Placebo in Patients With Chronic Obstructive Bronchitis (COPD)Pulmonary Disease, Chronic ObstructiveNCT02173691Boehringer Ingelheim584
已完成
不适用
Efficacy of Tiotropium in Patients after Pulmonary Resectionsung CancerJPRN-UMIN000001523Toneyama National Hospital20
已完成
3 期
Multiple Dose Comparison of Tiotropium Inhalation Capsules, Salmeterol Inhalation Aerosol and Placebo in Patients With Chronic Obstructive Pulmonary Disease (COPD)Pulmonary Disease, Chronic ObstructiveNCT02172287Boehringer Ingelheim623
撤回
2 期
Tiotropium Handihaler vs. Tiotropium Respimat in COPDChronic Obstructive Pulmonary Disease (COPD)NCT05838703Duke University
已完成
4 期
Comparison of 24 Hour Bronchodilator Efficacy of Tiotropium 18 mcg Delivered Via DISCAIR Versus SPIRIVA 18 µg Delivered Via HANDIHALER® in Patients With Moderate to Severe COPDCOPDNCT02541006Neutec Ar-Ge San ve Tic A.Ş58