EUCTR2005-004110-32-GB进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
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 (documented in patient notes) for more than 2 years
- •5.Patients must not be at risk of active tuberculosis including disease reactivation as indicated by a negative result in all 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)
- •(iii)Positive T SPOT™ -TB (Elispot) test
- •(iv)Chest x-ray (taken within the previous 2 years) suggesting healed or active TB
- •6.Current or ex-smokers with a smoking history of at least 10 years
- •7.FEV1 of 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%
- •When the patient returns to clinic for Visit 2, the following criteria should be fulfilled before they are considered eligible for randomisation.
- •8.Sputum producers with a history of chronic expectoration on most days of most weeks of the year (sputum colour, as recorded by the study site staff at Visit 2, of grade =3 (Bronkotest© diary card)
- •9.Patients must have a daily score for amount of sputum produced (from Bronkotest© diary card) of =2, for any 7 consecutive days during the baseline period (from Visit 1)
- •10.Patients must not have experienced exacerbation of their COPD since Visit 1
- •11.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
- •12.Patients must not have taken any disallowed medications during the baseline period (since signing consent)
- •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.Pregnant or lactating females
- •2.A history of asthma or seasonal allergic rhinitis with disease onset before 40 years of age
- •3.Concomitant diagnosis of clinical bronchiectasis, sarcoidosis or pulmonary disease other than COPD
- •4.Requirements for regular oxygen therapy
- •5.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
- •6.Known HIV infection or positive tests for Hepatitis B or C
- •7.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
- •8.Use of antibiotics within 4 weeks of Visit 1
- •9.Receipt of live, or live attenuated, vaccines within 4 weeks of Visit 1
- •10.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)
- •11.Chronic liver or renal disease
- •12.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
- •13.Any clinically significant deviations (as judged by the investigator) from the central laboratory reference ranges for other clinical chemistry, or haematology parameters at Visit 1
- •14.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)
- •15.Abnormal ECG for this patient population, as judged by the investigator including a QTc >450 ms
- •16.History of retinopathy
- •17.A history of hypersensitivity or intolerance to any ingredient in the investigational product
- •18.Use of disallowed medications (See Section 3.7.1 for detailed list)
- •19.Scheduled in-patient surgery or hospitalisation during the course of the study
- •20.History of or current drug abuseas judged by the investigator
- •21.Participation in another clinical study involving an investigational product within 90 days of Visit 1
- •22.Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
- •23.Previous enrolment or randomisation to treatment in the present study
研究者
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