EUCTR2005-004110-32-DE进行中（未招募）不适用
A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase II Study to Assess The Efficacy of AZD9056 (single oral 400 mg dose) when Administered for 4 Weeks in Patients with Moderate to Severe COPD - PACE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 190
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 informed consent (prior to any study-related
- •procedures or restrictions)
- •2. Male or female aged between 40 to 80 years
- •3. Females must be using 2 forms of contraception (eg, oral contraception and barrier
- •method) for the duration of the study, unless they are surgically sterile or
- •post-menopausal
- •4. Clinical diagnosis of COPD
- •5. Sputum producers with a history of chronic expectoration on most days of most
- •weeks of the year. Patients must produce at least 3 g of sputum during the morning
- •of Visit 1. (If this criterion is not fulfilled and it is felt that the weight does not
- •represent the normal sputum production for a particular patient, Visit 1 may be
- •deferred once only to allow the sputum assessment to be repeated.)
- •If the patient has fulfilled criteria 1-5, the following criteria should be assessed:
- •6. Patients must not be at risk of active tuberculosis including disease reactivation as
- •indicated by any of the following:
- •(i) Past medical history of TB or current symptoms suggestive of active TB
- •(ii) A positive tuberculin (Mantoux) test in response to intradermally dosed
- •tuberculin (either PPD RT23 SSI, 2 Tuberculin units/0.1 mL, solution for
- •injection (SSI, Copenhagen Denmark) or an equivalent local tuberculin
- •preparation). The following limits apply when using SSI tuberculin: 05 mm
- •= negative, =6 mm = positive for non-BCG immunised patients, =15 mm =
- •positive for BCG immunised patients.
- •(iii) Positive T SPOT ™ -TB (Elispot) test
- •(iv) Chest x-ray (taken within the previous 2 years) suggesting healed or active
- •7. Current or ex-smokers with a smoking history of at least 10 pack years
- •8. FEV1 of >0.7 L and 30-60% of the predicted normal value (pre-bronchodilator),
- •according to the European Community for Coal and Steel, and a FEV1/FVC ratio of
- •<70%. (If the patient has taken specific bronchodilators prior to the test within the
- •washout periods, this may be deferred but must be
- •completed prior to Visit 2.)
- •When the patient returns to clinic for Visit 2, the following criteria should be fulfilled before
- •they are considered eligible for randomisation.
- •9. Sputum colour, as recorded by the study site staff at Visit 2 (all patients) and
- •additionally Visit 1.2 for the sputum inflammatory marker sub-group, of grade =3
- •(Bronkotest © diary card) and sputum weight in all instances should be =3 g.
- •10. Patients must have a daily score for amount of sputum produced (from Bronkotest ©
- •diary card) of =1, for at least 7 consecutive days during the baseline period (from
- •11. Patients must not have experienced exacerbation of their COPD since Visit 1
- •12. During the baseline period, patients must have been able to show that they have
- •completed the diary card satisfactorily and that they are willing and able to
- •complete all remaining study procedures
- •13. Patients must not have taken any disallowed medications during the baseline 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. Pregnant or lactating females
- •2. A history of asthma
- •3. A history of seasonal allergic rhinitis with disease onset before 40 years of age
- •4. Concomitant diagnosis of clinical bronchiectasis, sarcoidosis or pulmonary disease
- •other than COPD
- •5. Requirements for regular oxygen therapy
- •6. Any other clinically significant disease or disorder (including insulin-dependent
- •diabetes and active peptic ulceration) which, in the opinion of the investigator, may
- •either put the subject at risk because of participation in the study, or may influence
- •the results of the study, or the subject’s ability to participate in the study
- •7. Known HIV infection or patients who belong to a high risk group for HIV or
- •positive tests for Hepatitis B or C
- •8. An exacerbation of COPD (defined as, an increase in respiratory symptoms
- •requiring hospitalisation and/or a course of oral glucocorticosteroids and/or
- •antibiotics (either prescribed or self-administered) within 8 weeks of Visit 1
- •9. Use of antibiotics within 4 weeks of Visit 1 for a reason other than COPD
- •10. Receipt of live, or live attenuated, vaccines within 4 weeks of Visit 1
- •11. History of malignancy and neoplastic disease (however, patients who have been
- •successfully treated for basal or squamous cell carcinoma of the skin more than
- •5 years ago, may be included)
- •12. Chronic liver or renal disease
- •13. Liver function tests (Aspartate aminotransferase (AST), Alanine aminotransferase
- •(ALT) or bilirubin) above the upper limit of normal (ULN) of central laboratory
- •reference range at Visit 1
- •14. Any clinically significant deviations (as judged by the investigator) from the central
- •laboratory reference ranges for other clinical chemistry, or haematology parameters
- •15. History of excessive alcohol consumption or current consumption of more than
- •28 units per week (male) or 21 units per week (female). (One unit of alcohol is
- •equivalent to half a pint of ordinary strength beer, lager, or cider; a quarter of a pint
- •of strong beer or lager; one small glass of wine; one single measure of spirits). This
- •will be judged by the Investigator
- •16. Abnormal ECG for this patient population, as judged by the investigator including a
- •QTc >450 ms
- •17. History of retinopathy
- •18. A history of hypersensitivity or intolerance to any ingredient in the investigational
- •19. Use of disallowed medications (See Section 3.7.1 for detailed list)
- •20. Scheduled in-patient surgery or hospitalisation during the course of the study
- •21. History of or current drug abuse, as judged by the investigator
- •22. Participation in another clinical study involving an investigational product within
- •90 days of Visit 1
- •23. Involvement in the planning and conduct of the study (applies to both AstraZeneca
- •staff or staff at the study site)
- •24. Previous enrolment or randomisation to treatment in the present study
- •25. History of recurrent or chronic infection (eg, sinusitis, UTI, genital herpes) or
- •patients with chronic eczema (ie, increased carriage of S. aureus).
研究者
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