EUCTR2005-003713-32-ES进行中（未招募）1 期
A phase II, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of UK-500,001 Dry Powder for Inhalation (DPI) in adults with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer SA
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female patients between, and including, the ages of 40 and 80 years. Females need to be of either non-childbearing potential; or if of childbearing potential may be included providing they are using acceptable methods of contraception.
- •2. Patients with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD, 2003 revision) and who meet the following criteria for Stage II III disease: Patients must have a post-bronchodilator FEV1/FVC ratio < 0.7 and a post-bronchodilator FEV1 of 30 - 80% (inclusive) of the predicted value for age, height, race and sex using European Community for Coal and Steel (ECCS) standards, Luxembourg 1993. To qualify for randomization, these criteria must be met at screen and replicated during run in phase.
- •3. Patients must have a smoking history of at least 10 pack years and meet one of the following criteria: 1) They are current smokers; or 2). They are ex smokers who have abstained from smoking for at least 6 months.
- •Formula for pack-years cigarettes = (average number of cigarettes/day ÷ 20) x years of smoking.
- •Formula for pack-years tobacco = ounces per week x 2/7 x years of smoking.
- •4. Patients must have stable disease for at least 1 month prior to screening. During the screening and run-in phase patients must be able to manage disease symptoms adequately with short acting bronchodilators only [i.e. inhaled ipratropium bromide 2 actuations (20mg/actuation) QID administered from a MDI +/- salbutamol rescue medication up to a maximum of 8 actuations (100mg/actuation) daily], without reliance on other therapies including oral or inhaled corticosteroids, long acting bronchodilators, nebulizer therapy, theophylline or regular oxygen.
- •5. Body Mass Index (BMI) < 35 kg/m2 and a total body weight >40 kg.
- •6. Patients must be able to give informed written consent prior to entering the study.
- •7. Patients must be willing and able to comply with scheduled visit and all study related procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalization for the treatment of COPD within 3 months of screening or more than twice during the preceding year.
- •2. History of a lower respiratory tract infection or significant disease instability during the month preceding screening or during the time between screening and randomization.
- •3. History or presence of respiratory failure, cor pulmonale or right ventricular failure. 4. Patients with home oxygen therapy (either prn or long term oxygen therapy, LTOT).
- •5. Any clearly documented history of adult asthma or other chronic respiratory disorders (e.g. bronchiectasis, pulmonary fibrosis, pneumoconiosis).
- •6. Known previous diagnosis of HIV infection, hepatitis B or C carrier status or chronic active hepatitis of any etiology (specific screening is not required).
- •7. History of cancer (other than cutaneous basal cell) in the previous 5 years.
- •8. History within the previous year of: myocardial infarction, cardiac arrhythmia (e.g. atrial fibrillation, paroxysmal atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia), left ventricular failure, unstable angina, coronary angioplasty, coronary artery bypass grafting (CABG) or cerebrovascular accident (including transient ischemic attacks).
- •9. Active tuberculosis within the previous 2 years.
- •10. History within the previous 6 months of:
- •a) an epileptic seizure.
- •b) poorly controlled Type 1 or Type 2 diabetes.
- •c) acute hepatitis of any etiology.
- •11. A major surgical operation within 1 month of screening.
- •12. Screening systolic blood pressure < 90mmHg.
- •13. ECG abnormalities at screening or randomization, including those listed below. The investigator will decide whether ECG abnormalities other than those listed are clinically significant and should exclude the patient from enrollment.
- •a)Predominant heart rhythm other than normal sinus rhythm e.g. atrial fibrillation, atrial flutter, supraventricular tachycardia.
- •b)Patients with pre randomization evidence of QTc prolongation (defined as >450 msec for men; >470 msec for women) are not eligible for randomization without Pfizer approval. This assessment is made by the investigator at the time of ECG collection.
- •c)Atrioventricular (AV) block greater than first degree.
- •d)Resting heart rate >100 or <40 bpm.
- •e)Evidence of previous myocardial infarction or significant ischemic changes in the absence of clinical history consistent with these findings.
- •14. History or evidence, based upon a complete medical history, full physical examination, posterior anterior chest X ray (within last 12 months), 12 lead resting ECG or clinical laboratory test results, of any other significant concomitant clinical disease that, in the opinion of the investigator, could interfere with the conduct, safety or interpretation of results of this study. Patients with certain chronic conditions such as hypertension, thyroid disease, Type 1 or Type 2 diabetes, hypercholesterolemia, gastroesophageal reflux, or depression may be included in the study as long as the conditions are well controlled and medications relating to the condition are stable and would not be predicted to compromise safety or interfere with the tests and interpretations of this study.
- •15. Female patients of childbearing potential who are unwilling or unable to use an acceptable method of contraception from screening until c
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A phase II, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of UK-500,001 Dry Powder for Inhalation (DPI) in adults with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). - NAEUCTR2005-003713-32-CZPfizer Ltd200