EUCTR2007-003962-16-FI进行中（未招募）不适用
A 4-week double-blind, placebo-controlled, randomised, parallel group phase IIa study to assess the tolerability/safety and efficacy of inhaled AZD4818 in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) - TOP
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
- •For inclusion in the study at Visit 1 the patients must fulfil all of the following criteria:
- •1. Provision of informed consent
- •2. Men, or women = 40 years of age. Women must be either surgically sterilised
- •or post-menopausal i.e. amenorrhoeic for 12 months and follicle-stimulating
- •hormone (FSH) plasma concentration is within the postmenopausal range as
- •defined by the central laboratory
- •3. Be able to inhale from the Turbuhaler according to given instructions
- •4. Body mass index between 18 and 30 kg/m2 and a minimum weight of 50 kg
- •5. Clinical diagnosis of COPD, with symptoms for more than 1 year
- •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)
- •7. FEV1 40 to 80 % of the predicted normal value (post-bronchodilator) and
- •post-bronchodilator FEV1/FVC < 70 %
- •8. Patients that can discontinue non-allowed concomitant medication.
- •9. A history of use of short acting ß2-agonist or anticholinergics as rescue medication
- •For inclusion in the study at Visit 2 the patients must fulfil all the following criterion:
- •1. A score = 1 on Breathlessness score on at least half of the numbers of 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), 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 tuberculosis (TB) defined as at least one (1) of the following:
- •(a) positive Mantoux-test. (>5 mm in unvaccinated individuals and >10 mm in
- •individuals with previous BCG-vaccination), and positive QuantiFERON®TB
- •Gold test (QFT), see Mori T et al 2004.
- •NB A QFT will only be performed after a positive Mantoux-test. If the readout of
- •the QFT is negative this will overrule the positive Mantoux test, hence no active
- •(b) suspicion of active tuberculosis on chest X-ray taken within last 6 months.
- •NB Abnormal chest X-ray consistent with past TB or a history of prior pulmonary,
- •or extrapulmonary TB, that has been adequately treated is not an exclusion criterion.
- •4. History of current clinically relevant arrhythmia, heart block, intraventricular
- •conduction delay or other clinical relevant ECG abnormalities, or unstable angina,
- •NYHA Class III-IV heart failure, as judged by investigator
- •5. Malignancy within the past 5 years
- •6. Disease history suggesting reduced or abnormal immune function
- •7. 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
- •8. QTcF >450 ms or QT >500 ms at Visit 1
- •9. A history of additional risk factors for Torsade de pointes (e.g., heart failure,
- •hypokalemia, family history of Long QT syndrome)
- •10. Requirement for regular oxygen therapy
- •11. An exacerbation of COPD (treatment with oral or parenteral antibiotics and/or
- •glucocorticosteroids (GCS) and/or hospitalization related to COPD) within 30
- •days of Visit 1, or during the run-in period
- •12. Use of oral or systemic glucocorticosteroids within 30 days prior to Visit 1, or
- •during the run-in periodt
- •13. Known or suspected hypersensitivity to study therapy or excipients (e.g., benzoate,lactose) of the investigational product
- •14. History of or current alcohol abuse or drug abuse, as judged by the investigator
- •15. Participation in another study involving drug administration within 3 months
- •16. A suspected/manifested infection according to WHO risk classification 2, 3 or 4
- •(See Appendix C)
- •17. Positive results on screening tests for hepatitis B and C
- •18. Known HIV infection, or patients who belong to a high risk group for HIV
- •19. Scheduled in-patient hospitalization during the course of the study
- •20. Donation of blood within 3 months or donation of plasma within 14 days prior
- •21. Clinical judgement by the investigator that the patient should not participate in
- •22. Previous randomization in this study
- •23. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site).
研究者
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