EUCTR2013-002652-32-DE进行中（未招募）不适用
A randomised, placebo-controlled, double-blind, single dose, cross-over study to evaluate the efficacy and safety of orally inhaled tiotropium + olodaterol as both a fixed dose combination and a free combination (both delivered by the Respimat® inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD) - Tiotropium/Olodaterol Fixed Dose Combination versus Free Combination
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 58
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
- •- patients must sign informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
- •- Patients must have a diagnosis of COPD and must meet the following spirometric criteria:
- •Patients must have relatively stable airway obstruction with a post-bronchodilator (10 to 45 minutes after 400mcg salbutamol) FEV1>30%
- •and < 80% of predicted normal (ECSC, GOLD II - III) and a post-bronchodilator FEV1/FVC <70% at Visit 1
- •- Male or female patients, 40 years of age or older.
- •- 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.
- •- Patients must be able to perform technically acceptable pulmonary function tests according to ATS/ERS guidelines and maintain records in a paper diary
- •- Patients must be able to inhale medication in a competent manner from the RESPIMAT inhaler and from a metered dose inhaler (MDI).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •- Significant disease other than COPD
- •- Clinically relevant abnormal lab values.
- •- History of asthma.
- •- Diagnosis of thyrotoxicosis
- •- Diagnosis of paroxysmal tachycardia
- •- 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
- •- Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
- •- History of life-threatening pulmonary obstruction and patients with chronic respiratory failure
- •- History of cystic fibrosis
- •- Clinically evident bronchiectasis
- •- History of significant alcohol or drug abuse
- •- Thoracotomy with pulmonary resection
- •- Patients treated with oral or patch ß-adrenergics
- •- Patients treated with oral corticosteroid medication at unstable doses or at doses in excess of 10mg prednisolone per day or equivalent
- •- Regular use of daytime oxygen therapy for more than one hour per day
- •- Pulmonary rehabilitation program in the six weeks prior to the screening visit or patients currently in a pulmonary rehabilitation program
- •- Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
- •- Known hypersensitivity to ß-adrenergic and/or anticholinergic drugs, BAC, EDTA
- •- Pregnant or nursing women
- •- Women of childbearing potential not using a highly effective method of birth control
- •- Patient who have previously been randomized in this study or are currently participating in another study
- •- Patients who are unable to comply with pulmonary medication restrictions prior to randomization
研究者
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