EUCTR2009-014594-40-DK进行中（未招募）不适用
A 12-week, Phase-II, Double-Blind, Placebo-Controlled, Randomised,Parallel-Group, Multi-Centre Study to Assess the Effect of 60 mg AZD9668Administered Orally Twice Daily on Structural Changes in the Airwaysby Multi-Slice Computed Tomography (MSCT) in Patients with ChronicObstructive Pulmonary Disease (COPD)
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
- 50
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 any study specific procedures at Visit 1a.
- •2. Male or female aged 50-80 years inclusive at Visit 1b.
- •Female patients may be of non-childbearing potential (i.e. post menopausal or
- •surgically sterile) or of child bearing potential:
- •- Women will be considered post menopausal if they are
- •i) over 50 years old and have been amenorrheic for 12 months or more
- •following cessation of all exogenous hormonal treatments or
- •ii) over 57 years old
- •- Surgically sterile is defined as having undergone hysterectomy and/or bilateral
- •oophrectomy and/or bilateral salpingectomy; tubal ligation on its own is not
- •- Women will be considered of child bearing potential if they are between
- •menarche and menopause, and have not been permanently or surgically
- •sterilised. Women of child bearing potential must have a pregnancy test at
- •visit 1b and at visit 2 prior to randomisation, and at the follow up visit, and
- •must be using suitable methods of birth control. Further details of methods of
- •birth control that are considered suitable for use are given in Section 5.1. in the protocol.
- •3. Documented clinical diagnosis of COPD, according to GOLD guidelines
- •(GOLD 2008) with symptoms for =1 year before Visit 1b.
- •4. Ex-smokers for at least 12 months prior to Visit 1b.
- •5. A smoking history of at least 10 pack years (1 pack year = tobacco consumption
- •corresponding to 20 cigarettes smoked per day for 1 year).
- •6. FEV1 40-70% (inclusive) of the predicted normal value (post-bronchodilator) at
- •7. FEV1/FVC <70% (post-bronchodilator) at Visit 1b.
- •8. Able to use the handheld electronic devices (assessed at Visit 1a).
- •For randomisation into the study at Visit 2 the patients must also fulfil the following criteria:
- •1. MSCT performed during the last 2 to 7 days before randomisation with acceptable
- •quality and the whole lung is visible on the images, as judged by the radiologist
- •visual read.
- •2. No clinically relevant abnormal findings in baseline CT besides CT changes
- •related to COPD, (e.g. congestive heart failure, lung cancer, tuberculosis, lung
- •fibrosis, sarcoidosis, cystic fibrosis) which in the opinion of the Investigator, may
- •put the patient at risk because of his/her participation in the study, or may influence
- •the results of the study, or the patient’s ability to participate in the study.
- •3. Complete morning recordings of daily FEV1 data at least 10 days out of the last
- •14 days before Visit 2.
- •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. Any clinically relevant disease or disorder (e.g. infectious/viral disease (including
- •hepatitis B or C) cardiovascular, pulmonary other than COPD, gastrointestinal,
- •liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant,
- •psychiatric, major physical impairment), past or present, 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.
- •2. Significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart
- •failure, uncontrolled hypertension, or any other relevant cardiovascular disorder
- •as judged by the Investigator.
- •3. Current diagnosis of asthma according to GINA guidelines (GINA 2008).
- •4. Malignancy or neoplastic disease within the past 5 years other than treated
- •basal/squamous cell skin carcinoma or treated cervical cancer in situ.
- •5. Patients who require long term oxygen therapy (LTOT).
- •6. Worsening of COPD within 4 weeks prior to Visit 1b and during the run-in period
- •(defined as an increase in respiratory symptoms requiring hospitalisation and/or a
- •course of oral glucocorticosteroids and/or increased usage/dose of inhaled steroids
- •and/or antibiotic treatment).
- •7. Acute infections requiring treatment in the 4 weeks prior to Visit 1b and during
- •the run-in period.
- •8. Any clinically relevant abnormal findings in physical examination, vital signs,
- •haematology, clinical chemistry, or urinalysis at Visit 1b, which in the opinion
- •of the Investigator, may put the patient at risk because of his/her participation
- •in the study, or may influence the results of the study, or the patient’s ability to
- •participate in the study.
- •9. A QTcB interval of >450 msec for males and >470 msec for females at Visit 1b.
- •10. Any ECG abnormality (including arrhythmia), which in the opinion of the
- •investigator may put the patient at risk or interfere with study assessments at
- •11. A past history of or current clinical or laboratory evidence of renal failure,
- •or an estimated creatinine clearance of <50 mL/min (as calculated by the
- •Cockcroft-Gault formula) at Visit 1b.
- •12. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) level
- •=1.5 x upper limit of normal (ULN) at Visit 1b.
- •13. Pregnancy, breast-feeding or planned pregnancy during the study.
- •14. Involvement in the planning and/or conduct of the study (applies to both
- •AstraZeneca staff and/or staff at the study site).
- •15. Previous randomisation to treatment in the present study.
- •16. Previous participation in a study with AZD9668.
- •17. Participation (defined as administration of at least 1 dose of investigational
- •product) in another clinical study, the last follow-up visit of which is within 12
- •weeks of Visit 1b in this study.
- •18. Excessive alcohol consumption or known drug abuse, as judged by the investigator.
- •19. Scheduled in patient surgery or hospitalisation during the course of the study.
- •20. Patients scheduled for an intensive COPD rehabilitation programme. (Patients
- •who are in the maintenance phase of a rehabilitation programme are eligible to
- •take part.)
- •21. Known or suspected hypersensitivity to the investigational product or excipients
- •or additional non-investigational study drugs provided for the study (tiotropium
- •and reliever medication).
- •22. Patients with conditions that may worsen if treated with tiotropium, according to
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