NCT02172807已完成3 期
A Multiple Dose Comparison of 18 µg, 36 µg of Ba679BR (Tiotropium) Inhalation Capsules and Oxitropium Metered Dose Inhaler (2 Puffs of 100µg) in a 4-week, 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
- 201
- 主要终点
- Trough forced expiratory volume in one second (FEV1.0) response
研究概览
简要总结
Study to investigate the efficacy and safety of Ba679BR powder inhalation during the continuous once/day administration to the patients with COPD using oxitropium bromide (Tersigan® aerosol) as the comparator drug.
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
- •Diagnosis of COPD (chronic bronchitis, and emphysema) with stable symptoms:
- •Screening FEV1.0 ≤70% of predicted normal vale and screening FEV1.0/FVC ≤70% (the baseline FEV1.0 should also be ≤70% of predicted normal value on the initial day of administration)
- •Smoking history ≥ 10 pack-years (a peak-year is 20 cigarettes per day for one year or equivalent)
- •Male or female patients 40 years of age or older
排除标准
- •History of bronchial asthma
- •History of an atopic disease such as allergic rhinitis
- •Total blood eosinophil count ≥ 600/µL
- •Patient treated with antiallergic drugs or anti-histamine drugs
- •Patients using oral corticosteroid medication at unstable doses (i.e. less than one month on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisolone per day
- •Patients using inhaled steroid, oral β2 stimulant, theophylline preparation, expectorant or macrolide antibiotic at unstable doses (i.e. less than one month on a stable dose)
- •Patients using an ACE inhibitor at unstable doses (i.e. less than one month on a stable dose)
- •Patients with known narrow-angle glaucoma
- •Patients with known symptomatic prostatic hypertrophy
- •Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system
- •Patients with significant diseases who in the opinion of the investigator were not eligible for the study
- •Patients with clinically significant abnormal baseline laboratory test values (hematology, blood chemistry, urinalysis). Patients with serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic-pyruvic transaminase (SGPT) twice the upper limit of the normal range, bilirubin 150% or creatinine 125% of the upper limit of the normal range were excluded
- •Patients with a recent history (i.e. within the 3 months prior to the screening visit) of myocardial infarction or heart failure
- •Patients with any cardiac arrhythmia requiring drug therapy
- •Patients who were treated with Patients who were treated with β-blockers-blockers
- •Patients with regular use of daytime oxygen therapy
- •Patients with known active tuberculosis or with obvious sequela of tuberculosis
- •Patients with a history of cancer within the last 5 years. Patients with treated basal cell carcinoma were allowed
- •Patients with a history of cystic fibrosis or bronchiectasis
- •Patients with upper respiratory tract infection in the past one month prior to the screening visit or during the baseline period
- •Patients who had taken an investigational drug within one month or six half lives (whichever is greater) prior to the screening visit
- •Pregnant or nursing women or women of childbearing potential
- •Other than the above, patients who in the opinion of the investigator were not eligible for the study
研究组 & 干预措施
Tiotropium low & Placebo
Experimental
Tiotropium 18 µg inhalation capsule and Placebo MDI
干预措施: Tiotropium low (Drug)
Tiotropium low & Placebo
Experimental
Tiotropium 18 µg inhalation capsule and Placebo MDI
干预措施: Placebo MDI (Drug)
Tiotropium high & Placebo
Experimental
Tiotropium 36 µg inhalation capsule and Placebo MDI
干预措施: Tiotropium high (Drug)
Tiotropium high & Placebo
Experimental
Tiotropium 36 µg inhalation capsule and Placebo MDI
干预措施: Placebo MDI (Drug)
Oxitropium & Placebo
Active Comparator
Oxitropium MDI (100 µg/puff) and Placebo inhalation capsules
干预措施: Placebo inhalation capsule (Drug)
Oxitropium & Placebo
Active Comparator
Oxitropium MDI (100 µg/puff) and Placebo inhalation capsules
干预措施: Oxitropium (Drug)
结局指标
主要结局
Trough forced expiratory volume in one second (FEV1.0) response
时间窗: Day 1, week 2 and 4
次要结局
- Patient's impression(week 4)
- FEV1.0 response at 1 hour after administration(Day 1, week 2 and 4)
- Trough forced vital capacity (FVC) response(Day 1, week 2 and 4)
- FVC response at 1 hour after administration(Day 1, week 2 and 4)
- Peak expiratory flow rate (PEF)(in the morning and at evening every day until week 4)
- COPD symptom scores(until week 4)
- Frequency of rescue use of β2 stimulant(until week 4)
- Physician's global evaluation(week 4)
- Occurrence of Adverse Events(up to 4 weeks)
- Change from baseline in blood pressure(Baseline, week 4)
- Change from baseline in heart rate(Baseline, week 4)
- Changes in ECG findings(Baseline, week 4)
- Changes from baseline in laboratory values(Baseline, week 4)
研究者
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