EUCTR2008-000340-13-DK进行中（未招募）不适用
A 4 week double-blind, placebo-controlled, randomized, parallel group phase IIa study to assess the efficacy and safety of AZD1981 in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 130
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 procedure
- •2. Men, or women = 40 years of age. Women must be either surgically sterilised or
- •post-menopausal ie amenorrhoeic for 12 months and follicle-stimulating hormone
- •(FSH) plasma concentration is within the postmenopausal range as defined by
- •the central laboratory
- •3. Clinical diagnosis of COPD, with symptoms for more than 1 year before visit 1b
- •4. BMI between 18 and 30 kg/m2 and a minimum weight of 50 kg
- •5. Current or ex-smokers with a smoking history of at least 10 pack years
- •6. FEV1 30-80% of the predicted normal value post-bronchdilator
- •7. FEV1/FVC<70% post-bronchodilator
- •8. Use of ß2-agonist and/or anticholinergics as reliever medication within 1 year of
- •For randomization in the study at visit 2 the patients must also fulfil the following criteria:
- •9. A score =1 on breathing score on at least half of the days of the run-in period.
- •10. A score =2 on sputum score on at least half of the 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
- •Any of the following is regarded as a criterion for exclusion from the study:
- •1. Any clinically relevant disease or disorder (past or present), including HIV or
- •Hepatitis B or C infection, which in the opinion of the investigator, may either put
- •the patient at risk because of participation in the study, or influence the results of
- •the study, or the patient’s ability to participate in the study
- •2. Any current respiratory disorder other than COPD, which is considered by the
- •investigator to be clinically significant or may influence the result of the study
- •3. History of or current clinically relevant arrhythmia, heart block, intraventricular
- •conduction delay or other clinically relevant ECG abnormalities, or unstable
- •angina, NYHA Class III-IV heart failure, as judged by the investigator
- •4. Malignancy or neoplastic disease within the past 5 years, other than treated
- •basal/squamous skin cancer or treated cervical cancer in situ
- •5. Disease history suggesting reduced or abnormal immune function
- •6. Any clinically relevant abnormal findings in physical examination, clinical
- •chemistry, haematology, urinalysis, vital signs or ECG at baseline, which, in
- •the opinion of the investigator, may put the patient at risk because of his/her
- •participation in the study
- •7. Requirement for long term oxygen therapy
- •8. An exacerbation of COPD within 30 days of visit 1b
- •9. Use of oral or systemic GCS within 30 days prior to visit 1b, or during the run-in
- •10. Known or suspected hypersensitivity to study therapy or excipients of the
- •investigational product
- •11. History of or current alcohol abuse or drug abuse, as judged by the investigator
- •12. Clinical judgement by the investigator that the patient is not suitable to participate in the study.
- •13. Participation in another study involving study drug administration within 3 months
- •of visit 1b, or within 1 month of visit 1b if the study did not involve study drug
- •administration
- •14. Blood donation (>500 ml) within 3 months of visit 1b
- •15. Scheduled inpatient hospitalisation during the study
- •16. Involvement in the planning and conduct of the study
- •17. Previous randomization of treatment in the present study
- •For randomization in the study at visit 2 the patients cannot fulfil the following criterion:
- •18. Use of any non-allowed medication during the run in period.
研究者
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