NCT02260011已完成2 期
A Single-Dose, Double Blind, Crossover Trial to Determinate the Comparability of Ipratropium Bromide HFA-134a Inhalation Aerosol to the Market Standard, Atrovent® CFC Inhalation Aerosol, 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
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 主要终点
- Forced expiratory volume in 1 second (FEV1) response, calculated as area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 (AUC0-6)
研究概览
简要总结
The objective of this study was to compare the bronchodilator efficacy and safety of ipratropium bromide HFA-134a inhalation aerosol and marketed, Atrovent® CFC Inhalation Aerosol in COPD patients
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
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 stable, moderate to severe airway obstruction with an FEV 1 (forced expiratory volume in the first second) <=65% of predicted normal and FEV1 <=70% of FVC (Forced Vital Capacity)
- •Males: Predicted normal FEV1=0.093 (height in inches) - 0.032(Age) - 1.343
- •Females: Predicted normal 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 ten pack-years
- •Patients must be able to demonstrate an improvement in FEV1 >=015% within one hour after inhalation of two puffs of Atrovent® inhalation aerosol (21 mcg per puff)
- •Patients must be able to satisfactorily administer the medication, perform pulmonary function test and maintain records during the study period as required in the protocol
- •All patients must sign an informed consent form prior to participation in the trial (i.e., prior to pre-study washout of their usual pulmonary medications and prior to fasting for laboratory tests)
排除标准
- •Patients with significant disease other than COPD were will be excluded. A significant 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 which may influence the results of the study or the patient's ability to participate in the study
- •Patients with clinical relevant 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 (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 the clinical condition. Repeat laboratory evaluation will not to be conducted in these patients
- •Patients with a history of asthma, allergic rhinitis or atopy or have a blood eosinophil count above 600/mm³. A repeat eosinophil count will not to be conducted in these patients
- •Patients with a recent history (i.e., one year or less) of myocardial infarction
- •Patients with a recent history (i.e., three years or less) of heart failure, patients with any cardiac arrhythmia requiring therapy, patients receiving any systemic beta blocker and patients on chronic daytime oxygen therapy
- •Patients with known active tuberculosis
- •Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed
- •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 or a thoracotomy for other reasons be evaluated as per exclusion criterion No. 1
- •Patients with an upper respiratory tract infection or COPD exacerbation in the six weeks prior to screening visit (vist1) or during the baseline period
- •Patients with known hypersensitivity to anticholinergic drugs
- •Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction
- •Patients with known narrow-angle glaucoma
- •Patients who are on cromolyn sodium or nedocromil sodium
- •Patients who are on antihistamines
- •Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (e.g., oral contraceptives, intrauterine devices, diaphragm or Norplant®)
- •Patients who have taken an investigational drug within one month or 6 half-lives (whichever is longer) of the drug prior to the screening visit or patients currently enrolled in other research study
- •Patients with a history of and/or active alcohol or drug abuse
- •Exclusion criteria for patients with allergies
- •Patients with active infectious rhinitis (common cold) as determined by history and physical
- •Patients with upper or lower respiratory infection at screening
研究组 & 干预措施
Ipratropium bromide HFA-134a low
Experimental
干预措施: Ipratropium bromide HFA-134a inhalation aerosol (Drug)
Ipratropium bromide HFA-134a high
Experimental
干预措施: Ipratropium bromide HFA-134a inhalation aerosol (Drug)
Atrovent® CFC low
Active Comparator
干预措施: Atrovent® CFC inhalation aerosol (Drug)
Atrovent® CFC high
Active Comparator
干预措施: Atrovent® CFC inhalation aerosol (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Forced expiratory volume in 1 second (FEV1) response, calculated as area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 (AUC0-6)
时间窗: After each drug administration
次要结局
- Changes in peak FEV1 response(Baseline and after each drug administration)
- Onset of therapeutic FEV1 response(After each drug administration)
- Duration of therapeutic FEV1 response(After each drug administration)
- Time to peak FEV1 response(After each drug administration)
- Forced Vital Capacity (FVC) AUC0-6(After each drug administration)
- Changes from baseline in FEV1(Baseline and after each drug administration)
- Number of patients with adverse events(Up to 5 month after first drug administration)
- Peak FVC response(After each drug administration)
- Changes from baseline in FVC(Baseline and after each drug administration)
研究者
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