EUCTR2009-010864-40-SE进行中（未招募）不适用
A double-blind, double-dummy, placebo-controlled, randomised, multi-centre, 5-way cross-over, single-dose study to investigate the local and systemic effects of inhaled AZD9164 compared to tiotropium in subjects with Chronic Obstructive Pulmonary Disease (COPD)
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
- 25
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 signed and dated ICF prior to any study specific procedures.
- •2. Men or post-menopausal women (defined as amenorrheic for 12 months and
- •FSH plasma concentration within the post-menopausal range as defined by the
- •laboratory) or surgically sterile woman.
- •3. Be aged 40 years or above at Visit 1.
- •4. Have a body mass index (BMI) = 19 kg/m2 and weigh = 50 kg.
- •5. A clinical diagnosis of COPD no later than Visit 1, with symptoms for more than 1
- •6. FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and
- •post-bronchodilator FEV1/FVC < 70%.
- •7. Current or ex-smokers with a smoking history of = 10 pack years (1 pack year
- •equals 20 cigarettes smoked per day for 1 year).
- •8. Chest radiography (not older than 6 months prior to Visit 1) not showing any
- •pathological changes that would make the subject unsuitable for inclusion as
- •judged by the Investigator.
- •9. Reversible airway obstruction, tested according to routines at the clinic. A
- •minimum of = 10% increase in FEV1 to 3 x 40 µg ipratropium at 2 occasions
- •separated by at least 1 day.
- •10. Be able to inhale from a Spira nebuliser and a HandiHaler ® device.
- •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. Symptoms of any clinically significant illness within 2 weeks prior to Visit 4.
- •2. An exacerbation of COPD (defined as use of systemic antibiotics and/or systemic
- •glucocorticosteroids (GCS) and/or hospitalisation related to COPD) within 30
- •days of Visit 1.
- •3. Any clinically significant disease or disorder (eg cardiovascular, pulmonary
- •other than COPD, gastrointestinal, liver, renal, neurological, musculoskeletal,
- •endocrine, metabolic, malignant, psychiatric, major physical impairment) which,
- •in the opinion of the Investigator, may either put the subject at risk because of
- •participation in the study, or influence the result of the study, or the subject’s
- •ability to participate in the study.
- •4. Any clinically relevant abnormal findings in physical examination, clinical
- •chemistry, haematology, urinalysis, vital signs, ECG or lung function at baseline,
- •which, in the opinion of the Investigator, may put the subject at risk because of
- •his/her participation in the study.
- •5. The use of concomitant medications that prolong the QT/QTc interval other
- •than inhaled ß2-agonists, eg, certain antihistamines, anti-arrhythmics, tricyclic
- •antidepressants and monoamine oxidase inhibitors.
- •6. QTcF > 450 ms or QT > 500 ms at Visit 2.
- •7. Treatment with systemic GCS within 30 days of Visit 4.
- •8. History of current clinically relevant arrhythmia, heart block, intraventricular
- •conduction delay or other clinical relevant ECG abnormalities, or unstable angina,
- •New York Heart Association (NYHA) Class III-IV heart failure, as judged by the
- •Investigator.
- •9. Any clinically important abnormalities in rhythm, conduction or morphology of
- •resting ECG that may interfere with the interpretation of QTc interval changes.
- •This includes subjects with any of the following:
- •- PR interval >200 ms (first degree AV block)
- •- Intermittent second or third degree AV block
- •- Dropped beats
- •- Incomplete, full or intermittent bundle branch block (QRS <110 ms with
- •normal QRS and T wave morphology is acceptable if there is no evidence of
- •left ventricular hypertrophy)
- •- Abnormal T wave morphology, particularly in the protocol defined primary
- •10. Any definite or suspected personal history of intolerance or hypersensitivity to
- •drugs and/or their excipients (including lactose, ipratropium, tiotropium or other
- •anticholinergics), judged to be clinically relevant by the Investigator.
- •11. History of significant urinary retention or bladder neck obstruction.
- •12. Donation of blood within 3 months or donation of plasma within 14 days prior
- •to Visit 1.
- •13. History of current alcohol or drug abuse, as judged by the Investigator.
- •14. A suspected/manifested infection according to International Airline Transportation
- •Association (IATA) (see CSP Appendix C for further information).
- •15. Need of long term oxygen therapy (LTOT) and/or saturation O2 < 92%.
- •16. Positive results on screening tests for hepatitis B and/or C and/or HIV.
- •17. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff and staff at the investigational site).
- •18. Participation in any clinical study with an investigational drug or new formulation
- •of a marketed drug within 3 months prior to Visit 4.
- •19. Participation in a methodology study (in which no drugs are administered), during
- •the study period, that may interfere with the results of this study, as judged by the
- •Investigator.
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