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Clinical Trials in the UK / NCT07082738
Recruiting Phase 2

A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

NCT07082738 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 2
Started
2025-06-27
Last updated
2026-09-09

Condition(s) studied

Chronic Obstructive Pulmonary Disease (COPD)

Investigational drug(s) / intervention(s)

AZD6793Placebo

AZD6793: Oral dosage

Placebo: Oral dosage

Study summary

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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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). * 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. * 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. * 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.

Primary outcome measure(s)

Trial sites (367)

FacilityCityRegionStatus
Research Site Birmingham Alabama Recruiting
Research Site Glendale Arizona Withdrawn
Research Site Phoenix Arizona Recruiting
Research Site Phoenix Arizona Recruiting
Research Site Phoenix Arizona Recruiting
Research Site Canoga Park California Withdrawn
Research Site La Mesa California Withdrawn
Research Site Los Angeles California Recruiting
Research Site Newport Beach California Recruiting
Research Site Norco California Recruiting
Research Site Tustin California Terminated
Research Site Lakewood Colorado Withdrawn
Research Site Brandon Florida Recruiting
Research Site Cape Coral Florida Recruiting
Research Site Clearwater Florida Recruiting
Research Site Clearwater Florida Recruiting
Research Site Jacksonville Florida Withdrawn
Research Site Lake City Florida Recruiting
Research Site Miami Florida Recruiting
Research Site Miami Florida Recruiting
Research Site Miami Florida Recruiting
Research Site Miami Florida Recruiting
Research Site Miami Florida Recruiting
Research Site Miami Lakes Florida Recruiting
Research Site Naples Florida Recruiting
Research Site Ocala Florida Recruiting
Research Site Ormond Beach Florida Recruiting
Research Site Plantation Florida Recruiting
Research Site Sarasota Florida Recruiting
Research Site Tamarac Florida Recruiting
Research Site Tampa Florida Recruiting
Research Site Tampa Florida Recruiting
Research Site Winter Park Florida Recruiting
Research Site Suwanee Georgia Withdrawn
Research Site West Des Moines Iowa Withdrawn
Research Site Lexington Kentucky Terminated
Research Site Zachary Louisiana Recruiting
Research Site Baltimore Maryland Recruiting
Research Site Baltimore Maryland Recruiting
Research Site Burlington Massachusetts Recruiting

+ 327 more sites — see the full list on the official registry below.

More AstraZeneca trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07082738 on ClinicalTrials.gov ↗ ← All trials in the UK