NCT02173782已完成3 期
A Randomized, Placebo-controlled, Within-device, Double-blind Tri-national Study to Compare the Safety and Efficacy of Berodual® Administered Via the Respimat® Device (50 µg Fenoterol Hydrobromide/20 µg Ipratropium Bromide and 25 µg Fenoterol Hydrobromide/10 µg Ipratropium Bromide, 1 Puff q.i.d) With That Administered Via the MDI (50 µg Fenoterol Hydrobromide/21 µg Ipratropium Bromide, 2 Puffs q.i.d) in COPD Patients Over a 12-week Period
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 892
- 主要终点
- Average forced expiratory volume in one second (FEV1) between 0 and 1 hour (Area under the curve (AUC0-1h)) in litres
研究概览
简要总结
To demonstrate that at least one of the two doses of Berodual® (50 µg fenoterol hydrobromide/20 µg ipratropium bromide and 25 µg fenoterol hydrobromide/10 µg ipratropium bromide, 1 puff q.i.d) administered via the Respimat® gives a bronchodilator response which is not inferior to that obtained from one dose of Berodual® (50 µg fenoterol hydrobromide/21 µg ipratropium bromide, 2 puffs q.i.d) administered via the MDI and that the safety profile is at least as good when COPD patients are treated for 12 weeks.
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
- •Age >= 40 years
- •Diagnosis of COPD according the following criteria:
- •screening FEV1<= 65% predicted
- •Screening FEV1/FVC <= 70%
- •Smoking history > 10 pack-years (a pack-year is 20 cigarettes per day for one year or equivalent
- •Able to be trained in the proper use of MDI and Respimat®
- •Able to be trained in the performance of technically satisfactory pulmonary function tests
- •All patients must be willing and able to sign informed consent in accordance with Good clinical Practice (GCP) and local legislation
排除标准
- •History of cardiovascular, renal, neurologic, liver or endocrine dysfunction (e.g. hyperthyreosis) if they are clinically significant. A clinically significant disease is defined as one 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 or the study or the patient's ability to participate in the study
- •Patients with a recent (<= one year) history of myocardial infarction
- •Tuberculosis with indication for treatment
- •History of cancer within the last five years (excluding basal carcinoma)
- •Patients who have undergone thoracotomy
- •Current psychiatric disorders
- •History of life-threatening pulmonary obstruction, cystic fibrosis or bronchiectasis
- •An upper and lower respiratory tract infection in the four weeks prior to the screening visit
- •Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction
- •Patients with known narrow-angle glaucoma or raised intra-ocular pressure
- •Patients with clinically significant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion
- •Patients with:
- •Serum glutamic oxalo-acetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) >200% of the upper limit of the normal range
- •Bilirubin >150% of the upper limit of the normal range
- •Creatinine >125% of the upper limit of the normal range
- •Patients who are on chronic oxygen therapy
- •Intolerance to aerosolised ipratropium- or fenoterol-containing products, or hypersensitivity to any of the MDI ingredients
- •Oral corticosteroid mediation at dose greater than 10 mg prednisolone per day or equivalent
- •Beta-blocker medication
- •Changes in the pulmonary therapeutic plan within the last four weeks prior to the screening visit (not including withholding of medication before the screening visit)
- •Concomitant or recent (within the last month) use of investigational drugs
- •History of drug abuse and/or alcoholism
- •Pregnant or nursing women and women of child-bearing potential not using a medically approved means of contraception
- •Previous participation in this study (i.e. having been allocated a randomized treatment number)
- •Patients with a history of asthma, allergic rhinitis or atopy or who have blood eosinophil count above 600/mm3 (a repeat eosinophil count will not be conducted in these patients) and those patients on antihistamines, anti-leukotrienes, sodium cromoglycate or nedocromil sodium
- •Patients who are unable to comply with the medication restrictions specified in section 4.2 or who cannot use an MDI without a spacer
研究组 & 干预措施
Berodual® Respimat ® high dose
Experimental
干预措施: Berodual® Respimat ® high dose (Drug)
Berodual® MDI
Active Comparator
干预措施: Berodual® MDI (Drug)
Berodual® Respimat® low dose
Experimental
干预措施: Berodual® Respimat ® low dose (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Average forced expiratory volume in one second (FEV1) between 0 and 1 hour (Area under the curve (AUC0-1h)) in litres
时间窗: after 12 weeks of treatment
次要结局
- Peak FEV1 between 0 and 1 hour post inhalation of study drug(on day 1 and 85)
- Average (FEV1) between 0 and 1 hour (AUC0-1h) in litres on previous test days(on day 1, 29, 57)
- Forced vital capacity (FVC) in litres measured at the same time as FEV1(on day 1, 29, 57 and 85)
- Symptom scores recorded on the patient diary card(up to 12 weeks)
- Onset of bronchodilatory response(on day 1 and 85)
- Peak expiratory flow (PEF) measured pre-medication, morning and evening, averaged weekly(up to 12 weeks)
- Use of rescue bronchodilator medication(up to 12 weeks)
- Number of patients with adverse events(up to 12 weeks)
- Total average FEV1 (TAUC0-1h)(day 85)
- Number of patients with clinically significant changes in vital signs(up to 12 weeks)
- Number of patients with clinically significant changes in laboratory parameters(Baseline and day 85)
- Number of patients with abnormal findings in physical examination(Baseline and day 85)
- Number of patients with clinically significant changes in electrocardiogram(Baseline and day 85)
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