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Gia","920000",{"type":56,"coordinates":2740},[2741,2742],105.08091,10.01245,{"lat":2742,"lon":2741},{"type":2745,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100599303","phase-2-a-study-to-investigate-the-effect-of-azd6793-in-participants-with-moderate-to-very-severe-chronic-obstructive-pulmonary-disease-100599303",false,"NCT07082738","A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease","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)","PRESTO","Inclusion Criteria:\n\n* Participant must be ≥40 years of age at the time of signing the informed consent.\n* Documented primary diagnosis of COPD for at least 12 months prior to enrolment.\n* Pre-BD FEV1\u002FFVC \\\u003C 0.7 at Visit 1 and pre- and post-BD FEV1\u002FFVC \\\u003C 0.7, and post-BD FEV1 ≥ 25% to \\\u003C 80% of predicted normal at Visit 2.\n* Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations in the 12 months prior to screening.\n* Documented stable regimen of inhaled triple maintenance therapy or inhaled dual maintenance therapy for ≥ 3 months prior to screening.\n* CAT score ≥ 10 at Visit 1.\n* Current or ex-smokers with a cigarette smoking history of ≥ 10 pack-years.\n* 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).\n* Negative pregnancy test at Visit 1 and Visit 3 for Women Of Child-Bearing Potential (WOCBP).\n\nExclusion Criteria:\n\n* 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).\n* Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant's respiratory symptoms.\n* Any unstable disorder, including, but not limited to, CV, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and\u002For cognitive impairment.\n* Significant left heart failure.\n* Unstable angina, acute coronary syndrome\u002Facute myocardial infarction or coronary intervention with percutaneous coronary intervention\u002Fcoronary artery bypass graft within 6 months of randomisation, uncontrolled arrhythmia, or cardiomyopathy, clinically significant aortic stenosis, or signs of pulmonary oedema or volume overload.\n* Pulmonary arterial hypertension, either idiopathic or due to connective tissue or thromboembolic disease.\n* History of another underlying condition that predisposes the participant to infections.\n* History of ulcerative colitis, Crohn's disease, or microscopic colitis diagnosed by either a gastroenterologist or by histopathology.\n* Abnormal laboratory findings.\n* Participants with evidence of active liver disease and\u002For evidence of chronic liver disease.\n* Participants with history of HIV infection or who test positive for HIV.\n* History of lung volume reduction surgery.\n* Current or history of malignancy within 5 years before the screening visit.","ALL","40 Years",{"count":2757,"type":2758},987,"ESTIMATED","INTERVENTIONAL",[2761],"PHASE2","This Phase IIb dose-ranging study will evaluate the efficacy and safety of 2 different doses of AZD6793 compared with placebo tablets in participants with moderate to very severe chronic obstructive pulmonary disease.",[2764],"Chronic Obstructive Pulmonary Disease (COPD)",[2766,2767,2768,2769,2770,27,2771],"COPD","Moderate COPD","Severe COPD","Very Severe COPD","chronic obstructive pulmonary disease","IRAK4 Inhibitor","2026-06-03",{"date":2774,"type":2775},"2026-06-04","ACTUAL",{"date":2777,"type":2775},"2025-06-27",{"date":2779,"type":2758},"2027-11-05",{"name":5,"class":6},366]