EUCTR2009-010669-22-GB进行中（未招募）1 期
A randomised, double-blind, parallel group study to assess the efficacy and safety of 52 weeks of once daily treatment of orally inhaled tiotropium plus olodaterol fixed dose combination (2.5 µg / 5 µg; 5 µg / 5 µg) (delivered by the Respimat® Inhaler) compared with the individual components (2.5 µg and 5 µg tiotropium, 5 µg olodaterol) (delivered by the Respimat® Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD) - TOnado 2
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,518
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
入选标准
- •. 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 diseaseand must meet the following spirometric criteria:
- •Patients must have relatively stable airway obstruction with a post-bronchodilator FEV1< 80% of predicted normal 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 years.
- •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;
- •2.Patients with a, in the opinion of the investigator, clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis;
- •3.Patients with a history of asthma.
- •Patients with any of the following conditions:
- •4.A diagnosis of thyrotoxicosis (due to the known class side effect profile of ß2-agonists).
- •5.A diagnosis of (>100 beats per minute) (due to the known class side effect profile of ß2-agonists).
- •6.A history of myocardial infarction within 1 year of screening visit (Visit 1).
- •7.Unstable or life-threatening cardiac arrhythmia.
- •8.Hospitalization for heart failure within the past year.
- •9.Known active tuberculosis.
- •10.A malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed).
- •11.A history of life-threatening pulmonary obstruction.
- •12.A history of cystic fibrosis.
- •13.Clinically evident bronchiectasis.
- •14.A history of significant alcohol or drug abuse.
- •15.Patients who have undergone thoracotomy with pulmonary resection
- •16.Patients being treated with oral or patch ß-adrenergics.
- •17.Patients being treated with oral corticosteroid medication at unstable doses
- •18.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.
- •19.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.
- •20.Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit (Visit 1).
- •21.Patients with known hypersensitivity to ß-adrenergic drugs, BAC, EDTA, or any other component of the RESPIMAT inhalation solution
- •22.Pregnant or nursing women.
- •23.Women of childbearing potential not using a highly effective method of birth control.
- •24.Patients who have previously been randomized in this study or are currently participating in another study.
- •25.Patients who are unable to comply with pulmonary medication restrictions prior to randomization.
研究者
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