CTRI/2009/091/000147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 Pharmaceuticals0 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 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
- •2. Patients with a history of asthma and/or total blood eosinophil count greater than 600/mm3
- •3. Patients with thyrotoxicosis, paroxysmal tachycardia (>100 beats per minute)
- •4. Patients with a history of myocardial infarction within 1 year of screening visit, unstable or life-threatening cardiac arrhythmia, hospitalization 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,
- •life-threatening pulmonary obstruction, cystic fibrosis, clinically evident bronchiectasis, significant alcohol or drug abuse
- •5. Patients who have undergone thoracotomy with pulmonary resection
- •6. Patients being treated with oral beta-adrenergics or 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.
- •7. Patients who regularly use daytime oxygen therapy for more than one hour per day.
- •8. 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
- •9. Pregnant or nursing women
- •10. Women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier).
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