EUCTR2008-002151-25-DK进行中（未招募）不适用
A Double-Blind, Randomised, Placebo-Controlled, Parallel Group Multi-Centre Phase IIa Study to Assess the Effects on Biomarkers in Induced Sputum, Blood and Urine of AZD1236 Administered as Oral Tablet in Moderate to Severe COPD Patients During a 6 Week Treatment Period.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •2. Men, or postmenopausal/hysterectomised/oophorectomised women = 40 years of
- •age. Postmenopausal women defined as being amenorrhoeic for at least 24 months.
- •3. A minimum weight of 50 kg
- •4. Diagnosis of COPD for at least 1 month.
- •5. FEV1 40-80% of the predicted normal value (post bronchodilator) and
- •post-bronchodilator FEV1/FVC<70%
- •6. Current or ex-smokers with a smoking history of at least 10 pack years (1 pack
- •year = 20 cigarettes smoked per day for one year. For cigars, cigarillos etc see
- •further information in the eCRF instructions)
- •7. Patients that are able to discontinue all non-allowed concomitant medication
- •8. Recent or current use of short acting rescue/reliever medication
- •9. Be able to comply with induced sputum procedure and produce sputum.
- •Randomisation inclusion criteria at Visit 3
- •1. A score = 1 on the breathlessness score on at least half of the numbers of days (at least 6 days with a score = 1 on the breathlessness score are needed).
- •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 (past or present), 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 tract disorders other than COPD, which are considered by
- •the investigator to be clinically significant or may influence the result of the study
- •3. A clinical suspicion of active or latent tuberculosis defined as any of the following:
- •a) positive tuberculosis test (such as Quantiferon GOLD or Mantoux-test,
- •>5 mm in unvaccinated individuals and >10 mm in individuals with previous
- •BCG-vaccination),
- •b) suspicion of active or latent tuberculosis on chest X-ray taken within last 12
- •c) past medical history of tuberculosis
- •4. Malignancy or neoplastic disease within the last 5 years, other than treated basal
- •squamous cell skin cancer or treated cervical cancer in situ
- •5. Disease history suggesting reduced or abnormal immune function
- •6. Any clinically relevant abnormal finding 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. Patients with glomerular filtration rate less than 60 ml/min, calculated as creatinine
- •clearance from serum-creatinine according to the Cockcroft and Gault formula:
- •(CLcreatinine (mL/min)=constant x (140-age) x weight (kg)/serum creatinine (µM).
- •Constant be ing 1.23 for me n and 1.04 for women
- •8. Known HIV infection, or patient who belong to high risk group of HIV
- •9. Increased Cardiac Troponin I>Upper Limit of Normal (ULN) at Visit 2
- •10. Patients with underlying musculoskeletal symptoms of unknown origin and
- •patients with shoulder girdle musculoskeletal symptoms or Dupuytrens contracture
- •symptoms as judged by the investigator
- •11. Requirement for regular oxygen therapy
- •12. An exacerbation of COPD (use of oral or parenteral antibiotics and/or oral or
- •parenteral glucocorticosteroids and/or hospitalisation related to COPD) within 30
- •days of Visit 2 or during run-in
- •13. Use of oral or parenteral glucocorticosteroids within 30 days prior to Visit 2, or
- •during the run-in period
- •14. Use of inhaled glucocorticosteroids within 14 days prior to Visit 2 or during the
- •run-in period
- •15. Known or suspected hypersensitivity to study therapy or excipients of the
- •investigational product
- •16. History of, or current alcohol abuse or drug abuse, as judged by the investigator
- •17. Scheduled in-patient hospitalisation during the course of the study
- •18. Donation of blood within 3 months prior to Visit 2
- •19. Vaccination within 2 weeks prior to Visit 2
- •20. Previous randomisation of treatment in the present study
- •21. Participation in another study involving drug administration within 3 months
- •22. Involvement in the planning and/or conduct of the study (applies to both
- •AstraZeneca staff and/or staff at the study site)
- •23. Clinical judgement by the investigator that the patient should not participate in
- •If the patient participates in the genetic part of the study these exclusion criteria apply as well:
- •24. Whole blood transfusion within 120 days of the date of genetic sample collection
- •25. Previous bone marrow transplant.
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