NCT02236182已完成2 期
A Double-blind, Placebo Controlled Trial to Assess the Safety of Two-week Administration of 80 mcg q.i.d. and 160 mcg q.i.d. of Ipratropium Bromide, as Delivered by the RESPIMAT® Device, in Patients With Chronic Obstructive Pulmonary Disease
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
- 57
- 主要终点
- Assessment of clinical significant findings in 24-hour ambulatory ECG monitoring
研究概览
简要总结
Study to assess the safety of two-week administration of 80 and 160 mcg of ipratropium bromide as delivered by the RESPIMAT® device and as determined by 24 hours ambulatory ECG monitoring in COPD patients. To assess the overall safety of the two doses of ipratropium bromide as delivered by the RESPIMAT® device when administered over a two-week period.
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
- •All patients must have a diagnosis of COPD and must meet the following spirometric criteria:
- •Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 <=65% of predicted normal and FEV1 <=70% of forced vital capacity (FVC). Predicted normal value will be calculated according to Morris
- •Males: FEV1 = 0.093 (Height in inches)-0.032 (age)-1.343
- •Females: FEV1 = 0.085 (Height. in inches)-0.025(age)-1.692
- •Male or female patients 40 years of age or older
- •Patients must have a smoking history of more than 10 pack-years. A pack-year is defined as the equivalent of smoking one pack of 20 cigarettes per day for a year
- •Patients must be able to perform pulmonary function tests (PFTs) and maintain records during the study period as required in the protocol
- •Patients must be able to be trained in the proper use of an inhalation aerosol and the RESPIMAT™ device
- •Patients must have a baseline electrocardiogram (ECG) with no clinical relevant arrhythmias or conduction system disease (e.g. right or left bundle branch block, second degree AV block or higher)
- •Patients must have an oxygen saturation of >=90% for >=92% of the recording time on overnight oximetry
- •All patients must sign an Informed Consent Form prior to participation in the trial (i.e., at least 24 hours (h) prior to the screening visit (Visit 1))
排除标准
- •Patients with clinically relevant diseases other than COPD will be excluded. A clinically relevant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease with may influence the results of the study or patient's ability to participate in the study
- •Patients with a recent history (i.e. one year or less) of myocardial infarction
- •Patients with a recent history (i.e. one year or less) of heart failure or patients with any past history or active cardiac arrhythmia requiring drug therapy
- •Patients who have a pacemaker
- •Patients with clinically relevant abnormal baseline hematology, blood chemistry or urinalysis. If the abnormality defines a disease listed as an exclusion criterion the patient is excluded
- •All patients with serum glutamic oxaloacetic transaminase / Aspartate aminotransferase (SGOT/AST) >80 IU/L, serum glutamic pyruvic transaminase / Alanine transaminase (SGPT/ALT) >80 IU/L, bilirubin >2.0 mg/dl, or creatinine >2.0 mg/dl will be excluded regardless of the clinical condition. Repeat laboratory evaluation will be not be conducted in these subjects
- •Patients who have a blood eosinophil count >=600/mm
- •A Repeat eosinophil count will be not be conducted in these patients
- •Patients with a history of cancer, other than treated basal cell carcinoma, within the last 5 years
- •Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis
- •Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reason should be evaluated per exclusion criterion No. 1
- •Patients with a history of asthma, allergic rhinitis or atopy
- •Patients with a history of and/or active alcohol or drug abuse
- •Patients with known active tuberculosis
- •Patients with an upper respiratory tract infection or COPD exacerbation in the past 6 weeks prior to the screening visit (Visit 1) or during the baseline period
- •Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction
- •Patients with known narrow-angle glaucoma
- •Patients with current significant psychiatric disorders
- •Patients with regular use of daytime oxygen therapy
- •Patients who are being treated with cromolyn sodium or nedocromil sodium
- •Patients who are being treated with antihistamines
- •Patients using oral corticosteroid medication at unstable doses (i.e. less than six weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day
- •Patients who are being treated with beta-blocker medication
- •Patients who have had changes in their therapeutic plan within the last six weeks prior to the screening visit (visit 1)
- •Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (e.g., oral contraceptive, intrauterine devices, diaphragm or Norplant®)
- •Patients with known hypersensitivity to ant cholinergic drugs or any other components of the ATROVENT® RESPIMAT™ solution including bacteriostatic agent benzalkonium chlorid (BAC) and edetic acid (EDTA)
- •Patients who have taken an investigational drug within 1 month or 6 half-lives (whichever is longer) prior to the screening visit (visit1)
- •Previous participation in this study
研究组 & 干预措施
Ipratropium Bromide low
Experimental
delivered via RESPIMAT®
干预措施: Ipratropium Bromide low dose (Drug)
Ipratropium Bromide high
Experimental
delivered via RESPIMAT®
干预措施: Ipratropium Bromide high dose (Drug)
Placebo
Placebo Comparator
delivered via RESPIMAT®
干预措施: Placebo (Drug)
结局指标
主要结局
Assessment of clinical significant findings in 24-hour ambulatory ECG monitoring
时间窗: Pre-treatment, on Day 7 and 13
Number of patients with adverse events
时间窗: Up to 15 days after first drug administration
Number of patients with clinical significant findings in ECG
时间窗: Up to 15 days after first drug administration
Number of patients with clinical significant findings in vital signs
时间窗: Up to 15 days after first drug administration
Number of patients with clinical significant findings in laboratory tests
时间窗: Up to day 15 after drug administration
Number of patients with paradoxical bronchospasm
时间窗: Up to 15 days after first drug administration
次要结局
- FEV1 (forced expiratory volume in the first second) AUC0-4 (Area under the curve from 0 to 4 hours)(Pre-treatment, up to 4 h after drug administration on Day 1 and 14)
- Peak FEV1(On Day 1 and 14)
- Onset of therapeutic FEV1 response(On Day 1 and 14)
- Time to peak FEV1 response(On Day 1 and 14)
- AUC(0-6h) (Area under the plasma concentration-time curve from 0 to 6 h)(Day 14)
- Cmax (maximum plasma concentration)(Day 14)
- Cmin(0h) (minimum plasma concentration before inhalation)(Day 14)
- Cmin(6h) (minimum plasma concentration at 6 hours after inhalation)(Day 14)
- Ae(0-2h) (urine excretion between 0 to 2 h)(Day 14)
- Ae(0-6h) (urine excretion between 0 to 6 h)(Day 14)
研究者
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