NCT02173691已完成3 期
A Multiple Dose Comparison of Tiotropium Inhalation Capsules, Salmeterol Inhalation Aerosol and Placebo in a Six-Month, Double-Blind, Double-Dummy, Safety and Efficacy Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 584
- 主要终点
- Trough forced expiratory volume in one second (FEV1) response
研究概览
简要总结
The objective of this study is to compare the long-term (six month) bronchodilator efficacy and safety of tiotropium inhalation capsules, salmeterol inhalation aerosol and placebo inpatients with COPD.
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 (Participant, Investigator)
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
- •Age ≥ 40 years.
- •A diagnosis of relatively stable, moderate to severe COPD with:
- •Screening FEV1 ≤ 60% of predicted normal value (calculated according to European Community for Coal and Steel (ECCS) criteria and screening FEV1/FVC ≤ 70%
- •Smoking history ≥ 10 pack-years (a pack-year is 20 cigarettes per day for one year or equivalent)
- •Ability to be trained in the proper use of the HandiHaler® device and Metered Dose Inhaler (MDI).
- •Ability to perform all study related tests including the Shuttle Walking Test, acceptable pulmonary function tests, including Peak expiratory flow rate (PEFR) measurements, and maintenance of diary card records.
- •Ability to give written informed consent in accordance with Good Clinical Practice and local regulations.
排除标准
- •Clinically significant diseases other than COPD.
- •Patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion, will be excluded.
- •All patients with a serum glutamic oxaloacetic transaminase (SGOT) > 80 IU/L, serum glutamic pyruvic transaminase (SGPT) > 80 IU/L, bilirubin >2.0 mg/dL or creatinine > 2.0 mg/dL will be excluded regardless of clinical condition.
- •A recent history (i.e., one year or less) of myocardial infarction.
- •Any cardiac arrhythmia requiring drug therapy or hospitalisation for heart failure within the past three years.
- •Inability to abstain from regular daytime use of oxygen therapy for more than 1 hour per day.
- •Known active tuberculosis.
- •History of cancer within the last five years (excluding basal cell carcinoma)
- •History of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis.
- •Patients who have undergone thoracotomy with pulmonary resection.
- •Any upper respiratory infection in the past six weeks prior to the screening visit or during the run-in period.
- •Current participation in a pulmonary rehabilitation programme or completion of a pulmonary rehabilitation programme in the six week prior to the screening visit.
- •Known hypersensitivity to anticholinergic drugs, salmeterol, or any of the components of the lactose powder capsule or MDI delivery systems.
- •Known symptomatic prostatic hypertrophy or bladder neck obstruction.
- •Patients with known narrow-angle glaucoma.
- •Current treatment with cromolyn sodium or nedocromil sodium.
- •Current treatment with antihistamines (H1 receptor antagonists).
- •Oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisolone per day or 20 mg every other day.
- •Current use of β-blocker medication.
- •Current treatment with monoamine oxidase inhibitors or tricyclic antidepressants.
- •Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception.
- •Patients with a history of asthma, allergic rhinitis or atopy or who have a total blood eosinophil count > 600mm
- •History of and/or active significant alcohol or drug abuse.
- •Concomitant or recent use of an investigational drug within one month or six half lives (whichever is greater) prior to the screening visit.
- •Changes in the pulmonary therapeutic plan within the six weeks prior to the screening visit.
- •Inability to comply with the medication restrictions specified in Section 4.2 of the trial protocol
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo inhalation powder capsules (Drug)
Salmeterol
Active Comparator
干预措施: Salmeterol inhalation aerosol (Drug)
Salmeterol
Active Comparator
干预措施: Placebo inhalation powder capsules (Drug)
Placebo
Placebo Comparator
干预措施: Placebo inhalation aerosol (Drug)
Tiotropium
Experimental
干预措施: Tiotropium inhalation powder capsules (Drug)
Tiotropium
Experimental
干预措施: Placebo inhalation aerosol (Drug)
结局指标
主要结局
Trough forced expiratory volume in one second (FEV1) response
时间窗: 6 months
Transition Dyspnoea Index (TDI) focal score
时间窗: 6 months
次要结局
- Occurrence of Adverse Events(27 weeks)
- Average FEV1 response(30 and 60 min prior to and 30 and 60 min, 2 and 3 h post treatment on day 1, week 2, 8, 16, 24)
- Peak FEV1 response(30 and 60 min prior to and 30 and 60 min, 2 and 3 h post treatment on day 1, week 2, 8, 16, 24)
- Trough FVC (forced vital capacity) response(30 and 60 min prior to and 30 and 60 min, 2 and 3 h post treatment on day 1, week 2, 8, 16, 24)
- Average FVC (forced vital capacity) response(30 and 60 min prior to and 30 and 60 min, 2 and 3 h post treatment on day 1, week 2, 8, 16, 24)
- Peak FVC (forced vital capacity) response(30 and 60 min prior to and 30 and 60 min, 2 and 3 h post treatment on day 1, week 2, 8, 16, 24)
- Individual FEV1 measurement(Day 1, weeks 2, 8, 16, 24)
- Individual FVC measurement(Day 1, weeks 2, 8, 16, 24)
- Patient peak expiratory flow rates (PEFR) twice daily(27 weeks)
- Physician's global evaluation on an 8-point-scale(27 weeks)
- COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)(27 weeks)
- Amount of salbutamol therapy used during the treatment period(27 weeks)
- Number and length of exacerbations of COPD(27 weeks)
- Number and length of hospitalizations for respiratory disease(27 weeks)
- Changes from baseline in St. George's Hospital Respiratory Questionnaire (SGRQ)(Day 1, week 8, 16, 24 and 27)
- Changes from baseline in Mahler Dyspnoea Index (Baseline Dyspnoea Index /Transitional Dyspnoea Index (BDI/TDI))(Baseline, week 8, 16, 24, 27)
- Health resource utilisation(27 weeks)
- Patient preference measures(Day 1 and week 24)
- Changes from baseline in Shuttle walking tests (SWT) and Borg dyspnea score(Day 1, week 8, 16, 24, 27)
- Changes from baseline in pulse rate and blood pressure in conjunction with spirometry(baseline, Day 1, week 2, 8, 16 and 24)
- Changes from baseline in physical examination and ECG(baseline and week 24)
- Changes from baseline in laboratory tests(baseline and week 24)
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