EUCTR2011-004253-11-GB进行中（未招募）1 期
A randomised, double-blind, placebo-controlled, parallel group study to determine the effect of 12 weeks treatment of orally inhaled tiotropium + olodaterol fixed dose combination (2.5/5 µg, 5/5 µg) delivered by the Respimat® Inhaler, on exercise endurance time during constant work rate cycle ergometry in patients with Chronic Obstructive Pulmonary Disease (COPD) (TorractoTM) - TorractoTM
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 544
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 chronic obstructive pulmonary disease and must meet the following spirometric criteria:
- •Patients must have relatively stable airway obstruction with, at visit 1:
- •- a post-bronchodilator 30% = FEV1 <80% of predicted normal (ECSC) and
- •- a post-bronchodilator FEV1/FVC <70% at Visit 1
- •3. Male or female patients, between 40 and 75 years (inclusive) of age on day of signing informed consent.
- •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 (spirometry), must be able to complete multiple symptom-limited cycle ergometry tests (and for a subset also shuttle walk tests), as required in the protocol.
- •6. 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:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 240
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
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
- •3. Patients with a history of asthma.
- •Patients with any of the following conditions:
- •4. A diagnosis of thyrotoxicosis
- •5. A diagnosis of paroxysmal tachycardia (>100 beats per minute)
- •6. A history of myocardial infarction within 1 year of screening visit
- •7. Unstable or life-threatening cardiac arrhythmia
- •8. Hospitalized 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 and patients with chronic respiratory failure
- •12. A history of cystic fibrosis
- •13. Clinically evident bronchiectasis
- •14. A history of significant alcohol or drug abuse
- •15. Any contraindications for exercise testing.
- •16. 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)
- •17. Patients being treated with any oral ß-adrenergics
- •18. Patients being treated with 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
- •19. 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
- •20. 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
- •21. Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea, such as arthritis in the leg, angina pectoris or claudication or morbid obesity
- •22. Patients with an endurance time more than 25 minutes during the training (Visit 2) or baseline (Visit 3) constant work rate cycle ergometry
- •23. Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit (Visit 1)
- •24. Patients with known hypersensitivity to ß-adrenergic drugs, anticholinergic drugs, BAC,
- •EDTA or any other component of the RESPIMAT inhalation solution delivery system
- •25. Pregnant or nursing women
- •26. Women of childbearing potential not using a highly effective method of birth control.
- •27. Patients who have previously been randomized in this study or are currently participating in another study
- •28. Patients who are unable to comply with pulmonary medication restrictions prior to
- •randomization
- •At sites performing the shuttle walk tests, patients with the following criteria will be excluded from the shuttle walk tests:
- •29. Patients who complete level 12 at the incremental shuttle walk test at visit 1a.
- •30. Patients with an endurance time more than 15 minutes during the training (Visit 2a) or baseline (visit
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