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 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
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
- 18 至 99（—）
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,
- •b) frequent productive cough (over the past 3 months coughed at least several
- •days a week and phlegm (sputum) is brought up at least several days a week), or
- •c) post-BD FEV1 < 50% predicted.
- •5. Participants who have a documented stable regimen of triple therapy (ICS +
- •LABA + LAMA) or dual therapy (ICS + LABA or LABA + LAMA) for >= 3 months prior
- •to enrolment.
- •6. Participants who are clinically stable and free from an exacerbation of COPD
- •for 1 month prior to SV1 (screening) and prior to Day 1.
- •7. Participants who are at least 70% compliant with each of the following:
- •morning e-Diary, evening e-Diary, and PEF measurements during the 14 days
- •preceding SV3 based on the e-Diary.
- •8. Body mass index within the range 18 to 40 kg/m2 (inclusive).
- •9. Male or female of non-childbearing potential.
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.
- •(d) Clinically significant aortic stenosis.
- •(e) Systemic hypertension
- •(f) Pulmonary arterial hypertension,
- •-Current diagnosis of asthma
- •-Clinically important pulmonary disease other than COPD
- •-Known history of allergy or reaction to any component of the study
- •intervention formulation, including hereditary fructose intolerance.
- •- Any other clinically relevant abnormal findings on physical examination,
- •laboratory testing including hematology, coagulation, serum chemistry, or
- •urinalysis; or recent lung imaging prior to randomization,
- •-History of a clinically significant infection (viral, bacterial, or fungal;
- •defined as requiring systemic antibiotics, antiviral, or antifungal medication
- •for > 7 days) within 4 weeks prior to SV3 (Day 1) (including unexplained
- •diarrhea) or clinical suspicion of infection at time of dosing.
- •-History of ANCA positive vasculitis or ANCA positive skin disease.
研究者
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