NCT00720499已完成2 期
Randomised, Double-blind, Cross-over Study to Assess the Efficacy and Safety of 4 Weeks of Once Daily Treatment of 2 Doses of Orally Inhaled BI 1744 CL, Each in Fixed Dose Combination (FDC) With 5 Microgram Tiotropium Bromide (Delivered by the Respimat® Inhaler) in Patients With COPD
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 24
- 主要终点
- Trough Forced Expiratory Volume in One Second (FEV1) Response [L] After Four Weeks of Treatment.
研究概览
简要总结
The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL administered with 5 microgram tiotropium bromide solution for inhalation, delivered by the Respimat® inhaler, once daily for four weeks in patients with chronic obstructive pulmonary disease (COPD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions
- •All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
- •Patients must have relatively stable airway obstruction with a post-bronchodilator FEV1 >= 30% of predicted normal and <80% of predicted normal and a post-bronchodilator FEV1 / FVC <70% at Visit 1
- •Male or female patients, 40 years of age or older
- •Patients must be current or ex-smokers with a smoking history of more than 10 pack years
- •Patients must be able to perform technically acceptable pulmonary function tests and PEF measurements, and must be able to maintain records (Patient Daily e-Diary) during the study period as required in the protocol
- •Patients must be able to inhale medication in a competent manner from the Respimat inhaler and from a metered dose inhaler (MDI).
- •additional inclusion criteria apply.
排除标准
- •Patients with a significant disease other than COPD
- •Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis;
- •Patients with a history of asthma or a total blood eosinophil count >= 600/mm
- •Patients with any of the following conditions:a diagnosis of thyrotoxicosis, a diagnosis of paroxysmal tachycardia (>100 beats per minute), a marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTcF* interval > 450 ms), a history of additional risk factors for Torsade de Pointes (TdP) (e.g. heart failure, hypokalemia, family history of Long QT Syndrome)
- •Patients with any of the following conditions:a history of myocardial infarction within 1 year of screening visit (Visit 1), a diagnosis of clinically relevant cardiac arrhythmia, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years, a history of life-threatening pulmonary obstruction, a history of cystic fibrosis, clinically evident bronchiectasis, a history of significant alcohol or drug abuse
- •Patients who have undergone thoracotomy with pulmonary resection
- •Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during clinic visits.
- •Pregnant or nursing women
- •Women of childbearing potential not using two effective method of birth control (one barrier and one non-barrier). Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years
- •Patients who have previously been randomized in this study or are currently participating in another study
- •Patients who are unable to comply with pulmonary medication restrictions prior to randomization
- •Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit
- •additional exclusion criteria apply.
研究组 & 干预措施
BI 1744 CL low dose+tiotropium bromide
Experimental
BI 1744 CL low dose plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation
干预措施: BI 1744 CL plus tiotropium bromide (Drug)
BI 1744 CL low dose+tiotropium bromide
Experimental
BI 1744 CL low dose plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation
干预措施: Respimat® Inhaler (Device)
BI 1744 CL medium dose+tiotropium bromide
Experimental
BI 1744 CL medium dose plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation
干预措施: BI 1744 CL plus tiotropium bromide (Drug)
BI 1744 CL medium dose+tiotropium bromide
Experimental
BI 1744 CL medium dose plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation
干预措施: Respimat® Inhaler (Device)
结局指标
主要结局
Trough Forced Expiratory Volume in One Second (FEV1) Response [L] After Four Weeks of Treatment.
时间窗: 1 hour (h), 10 minutes (min) before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29
Trough FEV1 was defined as the mean of the 2 FEV1 values at the end of the dosing interval, 24 hours post-drug administration. Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period. The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).
次要结局
- FEV1 Peak 0-3h Response(1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29)
- Individual FVC Measurements(1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29)
- FVC AUC (0-3h) Response(1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29)
- Trough FEV1 Response [L] After 2 Weeks of Treatment(1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on day 15)
- FEV1, AUC (0-6h) Response(1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29)
- FVC AUC (0-6h) Response(1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29)
- PEFR AUC (0-3h) Response(1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29)
- Individual FEV1 Measurements(1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29)
- FEV1 AUC 0-3h, Response(1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29)
- FEV1 (Unsupervised) AUC (6-12h) Response(6 hours (h), 9h and 12h after drug administration on day 29)
- Physician's Global Evaluation(Days 15 and 29)
- 12-lead ECG QRS Intervals(Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29)
- 12-lead ECG QTcF Intervals(Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29)
- Trough FVC Response(1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on day 15, in addition 4h, 5h, 6h after drug administration on day 29)
- PEFR AUC (6-12h) Response(1 hour (h) and 10 minutes before drug administration on day 1 and 6h, 9h and 12h after drug administration on day 29)
- Weekly Mean Evening PEFR(Weeks 1,2,3 and 4)
- Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (PRN Salbutamol [Albuterol])(Weeks 1,2,3 and 4)
- FVC Peak 0-3h Response(1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on day 29)
- PEFR Peak 0-3h Response(1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29)
- Patient Global Rating(4 weeks)
- Weekly Mean Morning PEFR(Weeks 1,2,3 and 4)
- Clinically Significant Abnormalities for Blood Chemistry, Haematology, Urinalysis and Physical Examination(14 weeks)
- Overall Marked Changes From Baseline in Vital Signs(Baseline to week 14)
- 12-lead ECG Heart Rate(Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29)
- 12-lead ECG PR Intervals(Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29)
- 12-lead ECG QTcB Intervals(Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29)
- 12-lead ECG QT Intervals(Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29)
- AUC (0-6H) FEV1 (Unsupervised), AUC (0-6H) PEFR (Unsupervised), FVC Peak (0-3h), AUC (6-12h) FEV1 (Unsupervised), AUC (6-12h) PEFR (Unsupervised), Individual PEFR Measurements (Supervised and Unsupervised), Individual PEFR Measurements (Unsupervised)(4 weeks)
研究者
研究点 (24)
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