EUCTR2008-002230-30-FI进行中（未招募）不适用
A 6 Week Double-Blind, Placebo-controlled, Randomised, Parallel Group Phase IIa Study to Assess the Tolerability/Safety and Efficacy of AZD1236 as an Oral Tablet in Patients with Moderate to Severe COPD. - CERA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
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 30 to 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 eCRF instructions)
- •7. Patients that are able to discontinue non-allowed concomitant medication
- •8. Recent or current use of short-acting rescue/reliever medication.
- •For inclusion in the study at Visit 3 the patients must fulfil the following criterion:
- •1. A score = 1 on Breathlessness score on at least half of the numbers of days during
- •the run-in period. (At least 6 days with a score = 1 on Breathlessness score are
- •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 disorder other than COPD, which is 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 mmin 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 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. Patients with glomerular filtration rate less than 30 mL/min, calculated as
- •creatinine clearance from serum-creatinine according to the Cockcroft and Gault
- •f o rm ula: (C Lcre atinine (ml/min)= constant x (140-a g e) x w eight (kg)/se rum
- •creatinine (µM). Constant being 1.23 for men and 1.04 for women
- •8. Known HIV infection, or patients who belong to a high risk group for 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 (treatment with oral or parenteral antibiotics and/or oral
- •or parenteral glucocorticosteroids (GCS) and/or hospitalization related to COPD)
- •within 30 days of Visit 2, or during the run-in period
- •13. Use of oral or parenteral glucocorticosteroids within 30 days prior to Visit 2, or
- •during the run-in period
- •14. Known or suspected hypersensitivity to study therapy or excipients of the
- •investigational product
- •15. History of, or, current alcohol or drug abuse, as judged by the investigator
- •16. Scheduled in-patient hospitalization during the course of the study
- •17. Donation of blood within 3 months prior to Visit 2
- •18. Vaccination within 2 weeks prior to Visit 2
- •19. Previous randomisation of treatment in the present study
- •20. Participation in another clinical study involving drug administration during the last
- •3 months before Visit 2
- •21. Involvement in the planning and/or conduct of the study (applies to both
- •AstraZeneca staff and/or staff at the study site)
- •22. 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:
- •23. Whole blood transfusion within 120 days of the date of genetic sample collection
- •24. Previous bone marrow transplant
研究者
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