JPRN-UMIN000046812招募中未知
Efficacy and safety of once-daily single-Inhaler TRiple(Trelegy Ellipta) therApy for Japanese with mild to moderate COPD in Kyushu - TRACK study
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 668
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 40years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Women of childbearing potential. This includes women who are pregnant or lactating or are planning on becoming pregnant during the study. 2. Patients with a current diagnosis of asthma.(However, those patients with a prior history of asthma are eligible if they have a current diagnosis of COPD, and patients with ACO-like features, namely those whose condition will be partially met to the conditions defined for ACO in JRS guidance, may be included). 3. Patients who cannot perform lung function tests 4. Patients who had acute respiratory tract infection (e.g. pneumonia) or moderate/severe COPD exacerbation within 4 weeks at the screening 5. Severe or unstable other comorbid diseases 6. Active respiratory infections or malignancies 7. Other chronic respiratory diseases (bronchiectasis, interstitial pneumonias, pneumoconiosis) 8. Patients who cannot use any inhalation devices 9. Past history of severe side effects or history of allergy/hypersensitivity to any corticosteroid, anticholinergic/muscarinic receptor antagonist, beta 2-agonist, lactose/milk protein or magnesium stearate or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the investigator contraindicates study participation. 10. Participants taking any investigational drug treatment within 30 days prior to Visit 1 or within five half-lives (t1/2) of the prior investigational study (whichever is the longer of the two). 11. Patients who are recognized as inappropriate subjects in the study by physicians (eg, dementia, psychological disorders, cerebrovascular diseases with palsy, etc), because we will get informed consents by patients themselves and will not set other gardiners or proxies for informed consents. 12. Other patients who are considered inappropriate according to the package inserts of both target drugs.
研究者
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