NCT00530842已完成4 期
Effect of Inhalation of a Free Combination of Tiotropium Once Daily 18 Mcg and Salmeterol Twice Daily 50 Mcg Versus a Fixed Combination of Fluticasone and Salmeterol Twice Daily (500/50 Mcg) on Static Lung Volumes and Exercise Tolerance in COPD Patients (a Randomised, Double-blind, Double Dummy, 16 (2 x 8) Weeks, Crossover Study).
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 344
- 试验地点
- 49
- 主要终点
- Post-dose TGV(FRC) (After 8 Weeks)
研究概览
简要总结
The primary objective of this study is to demonstrate that treatment with a free combination of tiotropium and salmeterol provides superior improvement in static lung volumes and exercise tolerance compared to a fixed combination of fluticasone and salmeterol in patients with COPD.
The secondary objective includes assessment of safety.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Treatment
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has signed an Informed Consent Form in accordance with GCP and local legislative requirements prior to participation in the trial, i.e., prior to pre-trial washout of any restricted medications.
- •The patient has a clinical diagnosis of chronic obstructive pulmonary disease (COPD).
- •The patient has relatively stable, moderate to severe airway obstruction.
- •The patient has a pre-bronchodilator forced expiratory volume in the first second (FEV1) less than or equal to 65% of predicted normal determined at Visit 1 using the following predicted equations (R94-1408):
- •Males Forced expiratory volume in the first second (FEV1) predicted [Litres (L)] = 4.30 x Height [metres] minus 0.029 x Age [years] minus 2.49
- •Females Forced expiratory volume in the first second (FEV1) predicted [Litres (L)] = 3.95 x Height [metres] minus 0.025 x Age [years] minus 2.60 and a Thoracic Gas Volume (Functional residual volume) ((TGV)(FRC)) bigger than 120% predicted normal at visit 1 (or historical data not older than 6 month)
- •Males Thoracic Gas Volume (Functional residual volume) ((TGV(FRC)) pred. [Litres (L)] = 2.34 x Height [metres] + 0.009 x Age [years] minus 1.09
- •Females Thoracic Gas Volume (Functional residual volume) ((TGV(FRC)) pred. [Litres (L)] = 2.24 x Height [metres] + 0.001 x Age [years] minus 1.00
- •The patient is at least 40 years and less than or equal to 75 years old.
- •The patient has a cigarette smoking history of at least 10 pack-years. A pack-year is defined as the equivalent of smoking one pack of cigarettes per day for a year.
- •The patient is able to perform all specified procedures and able to maintain all necessary records during the study period as required in the protocol.
- •The patient is able to inhale the trial medication from the HandiHaler device.
- •The patient is able to inhale the trial medication from the Diskus/Accuhaler device.
排除标准
- •a significant disease other than chronic obstructive pulmonary disease (COPD). (review contraindications for exercise testing),
- •a recent history of myocardial infarction within one year.
- •a recent history of heart failure, pulmonary oedema, or patients with cardiac arrhythmia or any contraindication to exercise described in the CTProtocol within the last
- •daytime supplemental oxygen.
- •a diagnosis of known active tuberculosis.
- •a history of cancer within the last 5 years.
- •a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis.
- •thoracotomy with pulmonary resection.
- •an upper respiratory tract infection or an exacerbation of chronic obstructive pulmonary disease (COPD)
- •a known hypersensitivity to anticholinergic drug, ß-adrenergic or corticosteroids, lactose or any other component of the inhalation capsule delivery system.
- •a known symptomatic prostatic hypertrophy or bladder neck obstruction.
- •a known moderate or severe renal insufficiency.
- •a known narrow-angle glaucoma.
- •a known untreated hypokalemia.
- •a known untreated thyrotoxicosis.
- •a history of asthma, allergic rhinitis or atopy, or a total blood eosinophil count larger than 600/mm
- •treatment with cromolyn sodium or nedocromil sodium
- •treatment with antihistamines or antileukotrienes.
- •treatment with tiotropium for 1 month before Visit
- •treatment with oral corticosteroid medication.
- •Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception
- •a history of or active alcohol or drug abuse.
- •an investigational drug within 1 month or 10 half lives
- •a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea.
- •participation in a rehabilitation program for chronic obstructive pulmonary disease (COPD).
- •treatment with monoamine oxidase inhibitors inhibitors or tricyclic antidepressants.
- •participation in another study.
- •more than eight puffs of salbutamol/day during the run-in period
结局指标
主要结局
Post-dose TGV(FRC) (After 8 Weeks)
时间窗: 8 weeks
Post-dose TGV(FRC) (Thoracic Gas Volume; co-primary endpoint) after 8 weeks
Endurance Time (After 8 Weeks)
时间窗: 8 weeks
Endurance time to the point of symptom limitation after 8 weeks during a constant work rate exercise test at 75% Wcap (co-primary endpoint)
次要结局
- Locus of Symptom Limitation at Peak Exercise During Exercise(8 weeks)
- Post-dose TGV(FRC) (After 4 Weeks)(4 weeks)
- Dyspnea and Leg Discomfort(8 weeks)
- Endurance Time (After 4 Weeks)(4 weeks)
- Static Lung Volumes(4 weeks)
- Static Lung Volumes (Percent)(4 weeks)
- Slow Vital Capacity (SVC)(4 weeks)
- Forced Expiratory Volume in 1 Second (FEV1)(4 weeks)
- Forced Vital Capacity (FVC)(4 weeks)
- FEV1 Over FVC (Percent)(4 weeks)
- Symptom Intensity During Exercise(4 weeks)
研究者
研究点 (49)
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