EUCTR2008-001933-84-IT进行中（未招募）不适用
A randomised, double-blind, double-dummy, placebo-controlled, parallel group study to assess the efficacy and safety of 48 weeks of once daily treatment of orally inhaled BI 1744 CL (5 mcg [2 actuations of 2.5 mcg] and 10 mcg [2 actuations of 5 mcg]) delivered by the Respimat Inhaler, and 48 weeks of twice daily Foradil (12 mcg) delivered by the Aerolizer Inhaler, in patients with Chronic Obstructive Pulmonary Disease (COPD) - ND
BOEHRINGER ING.0 个研究点目标入组 1,150 人开始时间: 2008年12月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,150
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. All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions. 2. 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 <80% of predicted normal (ECSC) and a post-bronchodilator FEV1/FVC <70% at Visit 1. 3. Male or female patients, 40 years of age or older. 4. Patients must be current or ex-smokers with a smoking history of more than 10 pack-year: Pack Years = ((Number of cigarettes/day)/20 cigarettes)x years of smoking. 5. 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. 6. Patients must be able to inhale medication in a competent manner from the Respimat inhaler, a dry powder inhaler (DPI) and from a metered dose inhaler (MDI)
- •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. Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient?s ability to participate in the study. 2. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT >x2 ULN, SGPT >x2 ULN, bilirubin >x2 ULN or creatinine >x2 ULN will be excluded regardless of clinical condition (a repeat laboratory evaluation will not be conducted in these patients). 3.Patients with a history of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma. If a patient has a total blood eosinophil count >=600/mm**3, source documentation is required to verify that the increased eosinophil count is related to a non-asthmatic condition. 4. Patients with any of the following conditions: - a diagnosis of thyrotoxicosis (due to the known class side effect profile of beta2-agonists) - a diagnosis of paroxysmal tachycardia (>100 beats per minute) (due to the known class side effect profile of beta2-agonists). 5. Patients with any of the following conditions: - a history of myocardial infarction within 1 year of screening visit (Visit 1) - unstable or life-threatening cardiac arrhythmia. - have been hospitalized for heart failure within the past year. - known active tuberculosis - a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed) - a history of life-threatening pulmonary obstruction - a history of cystic fibrosis - clinically evident bronchiectasis - a history of significant alcohol or drug abuse. 6. Patients who have undergone thoracotomy with pulmonary resection (patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1). 7. Patients being treated with any of the following concomitant medications: - oral beta-adrenergics - oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day. 8. 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. 9. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program. 10. Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit (Visit 1). 11. Patients with known hypersensitivity to beta-adrenergics drugs, BAC, EDTA, lactose or any other component of the Respimat inhalation solution or Aerolizer DPI delivery system. 12. Pregnant or nursing women. 13. Women of childbearing potential not using two effective methods 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. 14. Patients who have previously been random
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