NL-OMON53515
招募中
2 期
A Phase IIa Randomised, Double Blind, Placebo Controlled, Parallel Arm, Multi-Centre Study to Evaluate the Efficacy and Safety of Mitiperstat (AZD4831), for 12-24 Weeks, in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) - CRESCENDO
Astra Zeneca0 个研究点目标入组 25 人待定
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Chronic Obstructive Pulmonary Disease
- 发起方
- Astra Zeneca
- 入组人数
- 25
- 状态
- 招募中
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Participant must be 40 to 80 years of age inclusive, at the time of signing
- •2\. Participants who have a confirmed primary diagnosis of moderate to severe
- •COPD as per GOLD criteria (FEV1/FVC \< 0\.7, and post\-BD FEV1 \>\= 25% predicted).
- •3\. Participants who are current or ex\-smokers with a tobacco history of \>\= 10
- •pack\-years.
- •4\. Participants must be deemed at high risk of exacerbations as defined by any
- •one of the following:
- •a) a documented history of \>\= 1 moderate or severe AECOPD requiring systemic
- •corticosteroids and/or antibiotics for at least 3 days\* duration or
- •hospitalization for reason of AECOPD in the 24 months prior to screening,
排除标准
- •\- Participants with a significant COVID\-19 illness within 6 months of enrolment
- •\- As judged by the investigator, any evidence of any active medical or
- •psychiatric condition or other reason (at SV1 \[screening] and SV3 \[pre\-dose])
- •which in the investigator's opinion makes it undesirable for the participant to
- •participate in the study. This includes but is not limited to:
- •(a) Diabetes mellitus,
- •(b) History of left heart failure
- •(c) Unstable angina, acute coronary syndrome/acute myocardial infarction or
- •coronary intervention with percutaneous coronary intervention/coronary artery
- •bypass graft within 6 months, arrhythmia requiring treatment, or cardiomyopathy.
结局指标
主要结局
未指定
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