EUCTR2011-004659-37-BE进行中（未招募）1 期
A randomised, double-blind, 5 treatment arms, 4-period, incomplete cross-over study to determine the effect of 6 weeks treatment of orally inhaled tiotropium + olodaterol fixed dose combination (FDC) (2.5 / 5 µg; and 5 / 5 µg) (delivered by the Respimat® Inhaler) compared with tiotropium (5 µg), olodaterol (5 µg ) and placebo (delivered by the Respimat® Inhaler) on lung hyperinflation and exercise endurance time during constant work rate cycle ergometry in patients with Chronic Obstructive Pulmonary Disease (COPD) [MORACTO™ 1] - Tiotropium + olodaterol FDC effect on lunghyperinflation and exercise [MORACTO™ 1]
SCS Boehringer Ingelheim Comm.V0 个研究点目标入组 280 人开始时间: 2011年12月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 280
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
- •pulmonarydisease and must meet the following spirometric criteria:
- •Patients must have relatively stable airway obstruction with a
- •postbronchodilator FEV1 <80% of predicted normal (ECSC) ; GOLD II -
- •IV and a postbronchodilator FEV1/FVC <70% at Visit 1 (ECSC predicted
- •normal equations)
- •3. Male or female patients, between 40 and 75 years of age (inclusive)
- •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 during the study period as required in the
- •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 280
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 280
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 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 greater
- •than or equal to 600/mm3, source documentation is required to verify
- •that the increased eosinophil count is related to a non-asthmatic
- •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 paroxysmal tachycardia (>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
- •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
- •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 as outlined in protocol
- •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
- •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 greater than 25 minutes during the
- •training (Visit 1) or baseline constant work rate cycle ergometry at Visit
- •23. Patients who have taken an investigational drug within one month
- 另有 4 项未显示
研究者
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