JPRN-jRCT2080224022未知2 期
A Randomized, Double-Blind, Chronic Dosing (7-Day), Four-Period, Four-Treatment, Placebo-Controlled, Cross-Over, Multi-Center Study to Assess the Efficacy and Safety of Three Doses of PT001 in Japanese Subjects With Moderate to Severe COPD
适应症
试验速览
- 阶段
- 2 期
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
- >= 40age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •Clinical history of COPD with a moderate to severe classification
- •- Current and former smokers with a history of at least 10 pack-years of cigarette smoking
- •- Post-bronchodilator FEV1 must be 30% or more and <80% predicted normal value
排除标准
- •- Pregnancy
- •- Primary asthma diagnosis; Poorly controlled COPD defined as acute worsening of COPD that required treatment with corticosteroids or antibiotics in the 6-week interval prior to Screening or between Screening and Visit 2;
- •- Clinically significant abnormal ECG
- •- Other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung disease, and uncontrolled sleep apnea; Cancer that was not in complete remission for at least 5 years;
- •- Diagnosis of angle closure glaucoma
- •- A documented myocardial infarction within 1 year of Screening
研究者
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Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPDModerate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 18.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855MedDRA version: 18.0Level: LLTClassification code 10010953Term: COPD exacerbationSystem Organ Class: 100000004855EUCTR2014-004712-10-GBPearl Therapeutics, Inc.1,614
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