EUCTR2008-006334-10-BE进行中（未招募）1 期
Randomised, Double-Blind, Cross-over Study to Compare the 24-hour FEV1-time Profile of Orally Inhaled BI 1744 CL, delivered with the Respimat® Inhaler, after 3 Weeks of Once Daily (5 µg [2 actuations of 2.5 mg], 10 mg [2 actuations of 5 mg]) or Twice Daily (2 µg [2 actuations of 1 mg], 5 mg [2 actuations of 2.5 mg]) Administration in Patients with Chronic Obstructive Pulmonary Disease (COPD)
SCS Boehringer Ingelheim Comm.V0 个研究点目标入组 48 人开始时间: 2009年1月14日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
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 COPD (P06-12085) and must meet the following spirometric criteria:
- •Patients must have relatively stable airway obstruction with a post-bronchodilator FEV1 < 80% of predicted normal [ECSC, R94-1408] and a post-bronchodilator FEV1 / FVC < 70% at Visit 1 [See Section 5.1 for ECSC predicted normal equations]
- •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 years Patients who have never smoked cigarettes must be excluded
- •5.Patients must be able to perform technically acceptable pulmonary function tests
- •6.Patients must be able to inhale medication in a competent manner from the Respimat® inhaler (Appendix 10.1) 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/mm3, source documentation is required to verify that the increased eosinophil count is related to a non-asthmatic condition. A repeat eosinophil count will not be conducted in these patients.
- •4.Patients with any respiratory infection or COPD exacerbation in the 6 weeks prior to the Screening Visit (Visit 1) or during the baseline period.
- •5.Patients with any of the following conditions:
- •-a diagnosis of thyrotoxicosis (due to the known class side effect profile of
- •ß2-agonists)
- •-a diagnosis of paroxysmal tachycardia (>100 beats per minute) (due to the known class side effect profile of ß2-agonists)
- •6.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
- •7.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)
- •8.Patients being treated with any of the following concomitant medications:
- •–oral ß-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
- •9.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
- •10.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
- •11.Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1)
- •12.Patients with known hypersensitivity to ß-adrenergics drugs, BAC, EDTA or any other component of the Respimat® inhalation solution delivery system
- •13.Pregnant or nursing women
- •14.Women of childbearing potential not using two effective methods of birth control (one barrier, one non-barrier). Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilatera
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