A 12-week, double-blind, randomised, parallel group, multi-centre, study to evaluate efficacy and safety of budesonide/formoterol (Symbicort® Turbuhaler®) 320/9 µg one inhalation twice daily on top of tiotropium (Spiriva®) 18 µg one inhalation once daily compared with tiotropium 18 µg one inhalation once daily, in patients with severe chronic obstructive pulmonary disease (COPD) - CLIMB

AstraZeneca AB0 个研究点目标入组 620 人开始时间: 2007年3月27日最近更新: 2021年10月8日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: AstraZeneca AB
入组人数: 620

研究概览入排标准研究者记录与标识符相似试验

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. Provision of informed consent prior to conducting any study-related procedure
•2. Outpatient, man or woman =40 years
•3. A clinical diagnosis of COPD, and symptoms for more than 2 years
•4. A current or previous smoker with a smoking history equivalent to 10 or more
•pack years (1 pack year =20 cigarettes smoked per day for one year)
•5. A history of at least one COPD exacerbation, requiring a dose of oral steroids
•and/or antibiotics within 1 to 12 months before Visit 2
•6. FEV1 =50% of predicted normal value, pre-bronchodilator
•7. FEV1/VC <70%, pre-bronchodilator
•8. Able to read and write and use the electronic devices (eDiary and ePEF)
•To be randomised to the treatment period, the following criteria must be fulfilled at Visit 3:
•9. Total COPD symptom score =2 per day for at least 7 days of the run-in period (by
•totalling the breathing, cough, and chest tightness scores from the diary) or during
•at least half of the run-in period if longer than 14 days
•10. Complete morning recordings of PEF and GCSQ data at least 7 out of the last
•10 days of the run-in period
•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. Worsening of COPD during run-in or within 4 weeks prior to Visit 2, requiring
•hospitalisation, a course of oral and/or inhaled steroids and/or antibiotics
•2. Use of inhaled glucocorticosteroids within 2 weeks prior to Visit 2
•3. Use of oral/parenteral glucocorticosteroids within 4 weeks prior to Visit 2
•4. Any clinically relevant abnormal findings in physical examination and vital signs,
•which in the opinion of the Investigator, may put the patient at risk because of
•his/her participation in the study
•5. A history of asthma
•6. A history of seasonal allergic rhinitis before 40 years of age
•7. Significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart
•failure, renal failure, uncontrolled hypertension as defined by the Investigator, or
•any other relevant cardiovascular disorder as judged by the Investigator
•8. Regular oxygen therapy
•9. Any current respiratory tract disorder other than COPD, which is considered by
•the Investigator to be clinically significant
•10. Any significant disease or disorder which, in the opinion of the Investigator, may
•either put the patient at risk because of participation in the study, or may influence
•the results of the study, or the patient’s ability to participate in the study
•11. Patients with clinically significant narrow-angle glaucoma, significant prostatic
•hyperplasia or bladder-neck obstruction in whom treatment with tiotropium may
•be related to worsening of signs and symptoms related to these conditions, as
•judged by the Investigator
•12. Patients taking non-cardioselective ß-blocking agents
•13. Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women
•not using acceptable contraceptive measures, as judged by the Investigator
•14. Known or suspected hypersensitivity to study therapy or excipients of the study
•drugs, including atropine or its derivatives, and ipratropium and any component of
•this product, as judged by the Investigator
•15. Scheduled in-patient hospitalization during the course of the study
•16. Patients who have participated in a clinical study evaluating an investigational
•drug in the last 4 weeks prior to enrolment, or who have been previously allocated
•a randomisation code in this study
•17. Patients with a history of chronic alcohol or drug abuse or any condition associated with poor compliance
•18. Patients participating in or scheduled for an intensive COPD rehabilitation program
•19. Planned donation of blood during the study
•20. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)

研究者

发起方

AstraZeneca AB

相似试验

进行中（未招募）

1 期

A 12-week, double-blind, randomised, parallel group, multi-centre, study to evaluate efficacy and safety of budesonide/formoterol (Symbicort® Turbuhaler®) 320/9 µg one inhalation twice daily on top of tiotropium (Spiriva®) 18 µg one inhalation once daily compared with tiotropium 18 µg one inhalation once daily, in patients with severe chronic obstructive pulmonary disease (COPD) - CLIMBSevere Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 9.1Level: LLTClassification code 10010952Term: COPD

EUCTR2006-006796-21-SKAstraZeneca AB620

进行中（未招募）

不适用

EUCTR2006-006796-21-DEAstraZeneca AB620

进行中（未招募）

不适用

EUCTR2006-006796-21-HUAstraZeneca AB620

进行中（未招募）

不适用

EUCTR2006-006796-21-SEAstraZeneca AB620

进行中（未招募）

不适用

A 12 week, double-blind, randomized, parallel group, multicenter study to evaluate the efficacy and safety of the combination of aliskiren 300 mg and hydrochlorothiazide 25 mg compared to aliskiren 300 mg in patients with Stage II hypertensiohypertension

EUCTR2008-000862-21-DEovartis Pharma Services AG660