CTRI/2009/091/000141已完成3 期
A randomized, 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 µg [2 actuations of 2.5 µg] and 10 µg [2 actuations of 5 µg ]) delivered by Respimat® Inhaler, and 48 weeks of twice daily Foradil® (12 µg) delivered by the Aerolizer® Inhaler, in patients with Chronic Obstructive Pulmonary Disease (COPD)
Boehringer Ingelheim Shanghai Pharmaceuticals Co Ltd0 个研究点目标入组 860 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 860
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:post-bronchodilator FEV1<80% of predicted normal (ECSC) and a post-bronchodilator FEV1/FVC <70% at Visit 1
- •2. Male or female patients, 40 years of age or older
- •3. Patients must be current or ex-smokers with a smoking history of more than 10 pack years:
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 patientâ??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 >=ï? 600/mm3, 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
- •Ã?2-agonists)
- •- a diagnosis of paroxysmal tachycardia ( >100 beats per minute) (due to the
- •known class side effect profile of Ã?2-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 β-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 investigatorâ??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 β-adrenergics drugs, BAC, EDTA, lactose or
- •any other component of the Respimat® inhalation solution or Aerolizer® DPI delivery
- •12. Pregnant or nursing women
- •13. Women of childbearing potential not using two
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