Status:
RECRUITING
A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Lead Sponsor:
AstraZeneca
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
This Phase IIb dose-ranging study will evaluate the efficacy and safety of 3 different doses of AZD6793 compared with placebo tablets in participants with moderate to very severe chronic obstructive p...
Detailed Description
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 ...
Eligibility Criteria
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.
Key Trial Info
Start Date :
June 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 5 2027
Estimated Enrollment :
1160 Patients enrolled
Trial Details
Trial ID
NCT07082738
Start Date
June 27 2025
End Date
November 5 2027
Last Update
March 17 2026
Active Locations (363)
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1
Research Site
Birmingham, Alabama, United States, 35205
2
Research Site
Glendale, Arizona, United States, 85306
3
Research Site
Phoenix, Arizona, United States, 85027
4
Research Site
Phoenix, Arizona, United States, 85044