NCT02236169已完成2 期
An Open-Label, Crossover, Pharmacokinetic Trial to Determine the Comparability of 84 µg Ipratropium Bromide HFA-134a Inhalation Aerosol to 84 µg 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
- 30
- 主要终点
- Amount of unchanged ipratropium excreted in the urine from 0 to 24 h after a single dose
研究概览
简要总结
The objective of this study was to determine the pharmacokinetic comparability of 84 µg ipratropium bromide HFA-134a inhalation aerosol and 84 µg 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
- None
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 a stable, moderate to severe airway obstruction with an Forced Expiratory Volume in one second (FEV1) <=65% of predicted normal and FEV1 <=70% of Forced vital capacity (FVC)
- •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 age 40 years 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 cigarettes (20 cigarettes) per day for a year
- •Patients must be able to satisfactorily administer the medication, perform pulmonary function tests (PFTs) 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 diseases other than COPD 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 with may influence the results of the study or patients ability to participate in the study
- •Patients with clinically 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 be not be conducted in these patients
- •Patients with a history of asthma, allergic rhinitis or atopy or who have a blood eosinophil count above 600/mm
- •A repeat eosinophil count will be not be conducted in these patients
- •Patients with a recent (i.e., one year or less) history of myocardial infarction
- •Patients with a recent history (i.e., three years or less) of cardiac failure, patients with cardiac arrhythmia requiring therapy, patients receiving any systemic beta-blockers and patients on chronic daytime oxygen therapy
- •Patients with known active tuberculosis
- •Patients with a history of cancer within the last 5 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 of thoracotomy for other reason should be evaluated per exclusion criterion No.1
- •Patients with an upper respiratory tract infection or COPD exacerbation in the 6 weeks prior to the screening visit (Visit 1) 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 and women of childbearing potential not using a medically approved means of contraception (e.g., oral contraceptive, intrauterine devices, diaphragm or Norplant®)
- •Patients who have taken an investigational drug within 1 month or 6 half-lives (whichever is longer) of the drug prior to the screening visit or patients currently enrolled in another research study
- •Patients with a history of and/or active alcohol or drug abuse
研究组 & 干预措施
Ipratropium bromide
Experimental
干预措施: Ipratropium bromide HFA-134a inhalation aerosol (Drug)
ATROVENT
Active Comparator
干预措施: Atrovent CFC inhalation aerosol (Drug)
结局指标
主要结局
Amount of unchanged ipratropium excreted in the urine from 0 to 24 h after a single dose
时间窗: Up to 24 hours (h) after single drug administration
Amount of unchanged ipratropium excreted in the urine within 1 hour at steady state
时间窗: 1h after drug administration
Amount of unchanged ipratropium excreted in the urine over the 6 h dosing interval at steady state
时间窗: up to 6 h after drug administration
次要结局
- Area under the plasma ipratropium concentration time curve at different time points(Up to 23 days after first drug administration)
- Peak plasma ipratropium concentration at different time points(Up to 23 days after first drug administration)
- Trough plasma ipratropium concentration at different time points(Up to 23 days after first drug administration)
- Time to peak plasma ipratropium concentrations at steady state(Up to 23 days after first drug administration)
- Degree of fluctuation (DF) of the plasma ipratropium concentrations(Up to 23 days after first drug administration)
- Area under the plasma ipratropium concentration time curve(Day 1 after first drug administration)
- Peak plasma ipratropium concentration(Day 1 after first drug administration)
- Number of patients with adverse events(Up to 23 days after first drug administration)
- Changes from baseline in pulse rate and blood pressure(Baseline, day 23 day after first drug administration)
- Number of patients with clinical significant findings in laboratory tests(Up to 23 days after first drug administration)
- Number of patients with clinical significant findings in physical examination(Up to 23 days after first drug administration)
- Number of patients with clinical significant findings in electrocardiogram (ECG)(Up to 23 days after first drug administration)
- Changes from test-day baseline in pulse rate and blood pressure(Up to 23 days after first drug administration)
研究者
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