EUCTR2008-003780-38-IT进行中（未招募）1 期
A Dose-Ranging Study of the Effects of SCH 527123 in Subjects With Moderate to Severe COPD - ND
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
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. A subject must be >40 to <75 years of age, of either sex, and of any race. 2. A subject must have a diagnosis of COPD based on the American Thoracic Society/European Respiratory Society (ATS/ERS)/Global Initiative for Chronic Obstructive Lung Disease (GOLD) current guidelines, or have had symptoms consistent with COPD for more than 2 years prior to the baseline visit. 3. A subject must have clinically stable COPD, indicated by no exacerbation or change in COPD treatment within 6 weeks before Screening or between Screening and Randomization. 4. A subject must have a history for more than 3 months prior to Screening of sputum production most days of the week. 5. At Screening and at Baseline, in subjects at sites performing sputum induction, post-bronchodilator FEV1 must be greater than 1000 mL. 6. At Screening, a subjects post-bronchodilator FEV1 must be between 30% and 70% of the predicted value. 7. At Screening and Baseline, a subjects ratio of post-bronchodilator FEV1 to forced vital capacity (FVC) must be greater than 70%. 8. A subject must be either an ex-smoker with at least 6 months of smoking cessation, or a current smoker, and must have a smoking history of more than 10 pack-years (eg, 10 pack-year history is equal to smoking 1 pack of cigarettes per day for 10 years or 2 packs per day for 5 years). 9. If a subject had used inhaled corticosteroids (ICS) during the 6 weeks prior to Screening, the subject must have kept to a stable, low or medium daily dosage of ICS, alone or in combination with a long-acting beta-agonist (LABA) or a long-acting muscarinic antagonist (LAMA), within the 6 weeks prior to Screening and between Screening and Randomization, and must agree to continue at this dosage throughout the study unless directed by the investigator. 10. A female subject of child-bearing potential must agree to use a medically acceptable, highly effective method of birth control (ie, failure rate less then 1% per year when used consistently and correctly) prior to Screening, and agree to continue using it while in the study (Screening and Treatment periods) if she is heterosexually active.
- •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. Subject who has been diagnosed with asthma or other clinically relevant lung disease (other than COPD) that, in the opinion of the investigator, precludes the subject from participating in the study (eg, sarcoidosis, tuberculosis, pulmonary fibrosis, severe bronchiectasis, or lung cancer). 2. Subject with clinically significant chest X-ray or computed tomography (CT) findings (eg, mass) inconsistent with stable COPD. 3. Subject who has undergone lobectomy, pneumonectomy, lung volume reduction (including bronchoscopic lung volume reduction) or any lung surgery other than biopsy. 4. Subject who has had a respiratory tract infection within 6 weeks prior to the Screening Visit. 5. Subject with acute, non-respiratory infection(s) at Screening should be excluded until resolution of the infection(s), as determined by the investigator. 6. Subject with >20% and 200 mL improvement at Screening in post bronchodilator FEV1. 7. Subject in need of supplemental oxygen therapy for >12 hours per day. 8. Subject who is breast-feeding, pregnant, or intends to become pregnant during the study. 9. Subjects who decide to discontinue smoking before Randomization are ineligible to participate. However, once enrolled, if a subject elects to discontinue smoking, or reduces cigarette consumption, he/she will be allowed to complete the study. 10. Subject who is using medication that may interfere with the effect of the study medication, or who has a clinically relevant medical condition that may interfere with the study procedures or evaluation, or any condition that is determined by the principal investigator to be significant. 11. Subject with a PBN count of <3 ? 109/L at the Visit 1 (Screening Visit).
研究者
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