A study to investigate the effect of AZD6793 in participants with moderate to very severe chronic obstructive pulmonary disease

Trial details

Who runs it

AstraZeneca AB

Trial code

EU 2025-520473-40-00

Record updated

2026. augusztus 17.

Original description

To evaluate the effect of AZD6793 as compared to placebo on the rate of moderate or severe COPD exacerbationsRead full original descriptionShow less

A Multicentre, Parallel-group, Phase IIb, Randomised, Double blind, Placebo-controlled, 3-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).

To evaluate the effect of AZD6793 as compared to placebo on the rate of moderate or severe COPD exacerbations

Inclusion: Participant must be ≥40 years of age at the time of signing the informed consent; Documented primary diagnosis of 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 2; 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 1; 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 are also exacerbation free for at least 4 weeks (28 days) prior to Visit 3 (randomisation); Negative pregnancy test at Visit 1 and Visit 3 for Women Of Child-Bearing Potential (WOCBP).

Exclusion: 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; 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; Significant left heart failure (ie, NYHA class III and IV or LVEF < 40% on echocardiogram or cardiac MRI; Abnormal laboratory findings (ALT or AST, TBL, Hb, WBC < LLN, neutrophil count, estimated glomerular filtration rate, platelet count).

EU CTIS 2025-520473-40-00