2025-520473-40-00招募中2 期
A Multicentre, Parallel-group, Phase IIb, Randomised, Double blind, Placebo-controlled, 4-Arm, 24-Week Study to Evaluate the Efficacy and Safety of AZD6793 Tablets in Adult Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (PRESTO).
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 314
- 试验地点
- 78
- 主要终点
- Annualised rate of moderate or severe COPD exacerbations
研究概览
简要总结
To evaluate the effect of AZD6793 as compared to placebo on the rate of moderate or severe COPD exacerbations
研究设计
- 分配方式
- Randomized
- 主要目的
- Follow-up
- 盲法
- Double (Investigator, Carer, Analyst, Monitor, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participant must be ≥40 years of age at the time of signing the informed consent.
- •Documented primary diagnosis of moderate to very severe COPD for at least 12 months prior to enrolment.
- •Pre-BD FEV1/FVC < 0.7 at Visit 1 and pre- and post-BD FEV1/FVC < 0.7, and post-BD FEV1 ≥ 25% to < 80% of predicted normal at Visit
- •Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations in the 12 months prior to screening
- •Documented stable regimen of inhaled triple maintenance therapy or inhaled dual maintenance therapy for ≥ 3 months prior to screening.
- •CAT score ≥ 10 at Visit
- •Current or ex-smokers with a cigarette smoking history of ≥ 10 pack-years.
- •Participants who are clinically stable and free from an exacerbation of COPD for 4 weeks prior to Visit 1 and remain exacerbation free at Visit 3 (randomisation).
- •Negative pregnancy test at Visit 1 and Visit 3 for Women Of Child-Bearing Potential (WOCBP).
排除标准
- •Clinically important pulmonary disease other than COPD (eg, asthma [current diagnosis per GINA or other accepted guidelines], active pulmonary infection, clinically significant bronchiectasis when bronchiectasis is the predominant diagnosis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha-1 antitrypsin deficiency or primary ciliary dyskinesia).
- •Participants with evidence of active liver disease and/or evidence of chronic liver disease.
- •Participants with history of HIV infection or who test positive for HIV.
- •History of lung volume reduction surgery
- •Current or history of malignancy within 5 years before the screening visit.
- •Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant’s respiratory symptoms
- •Any unstable disorder, including, but not limited to, CV, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment.
- •Significant left heart failure (ie, NYHA class III and IV or LVEF < 40% on echocardiogram or cardiac MRI.
- •Unstable angina, acute coronary syndrome/acute myocardial infarction or coronary intervention with percutaneous coronary intervention/coronary artery bypass graft within 6 months of randomisation, uncontrolled arrhythmia, or cardiomyopathy, clinically significant aortic stenosis, or signs of pulmonary oedema or volume overload.
- •Pulmonary arterial hypertension, either idiopathic or due to connective tissue or thromboembolic disease.
- •History of another underlying condition that predisposes the participant to infections.
- •History of ulcerative colitis, Crohn’s disease, or microscopic colitis diagnosed by either a gastroenterologist or by histopathology.
- •Abnormal laboratory findings (ALT or AST, TBL, Hb, WBC < LLN, neutrophil count, estimated glomerular filtration rate, platelet count)
结局指标
主要结局
Annualised rate of moderate or severe COPD exacerbations
Annualised rate of moderate or severe COPD exacerbations
次要结局
- Time to first moderate or severe COPD exacerbation: *Annualised rate of COPD exacerbations associated with emergency room visits, urgent care visits, or hospitalizations. *Annualised rate of severe COPD exacerbations. A severe exacerbation is defined as an exacerbation resulting in hospitalization or death due to COPD.
- * Annualised rate of COPDCompEx events. * Time to first COPDCompEx event.
- * Change from baseline in pre-bronchodilator (BD) FEV1 at Week 12 and Week 24. * Change from baseline in post-BD FEV1 at Week 12 and Week 24."
- Change from baseline over 24 weeks in each of the following: - - Breathlessness, Cough and Sputum Scale (BCSS) total score. - COPD Assessment Test (CAT) total score - St George's Respiratory Questionnaire (SGRQ) total and domain scores.
- AZD6793 plasma concentrations at specific timepoints.
- Safety and tolerability evaluations as assessed by AEs, SAEs, AESis (X-ray confirmed pneumonia, serious infections, herpes zoster infections, severe COVID-19 infections, haematology events [anaemia, neutropenia, thrombocytopaenia], skin and hair depigmentation events during skin examinations) vital signs, physical examinations, clinical laboratory assessments (clinical chemistry, male reproductive hormones, haematology, and urinalysis), and ECGs
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (78)
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