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A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Sponsor: AstraZeneca
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Interventions: AZD6793, Placebo
Countries: United States, Argentina, Australia, Bulgaria, Canada, Chile, China, Denmark
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 overview
Sex: ALL
Age: 40 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
Locations (368)
- Birmingham, Alabama, United States
- Glendale, Arizona, United States
- Phoenix, Arizona, United States
- Phoenix, Arizona, United States
- Phoenix, Arizona, United States
- Canoga Park, California, United States
- La Mesa, California, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Norco, California, United States
- Tustin, California, United States
- Lakewood, Colorado, United States
- Brandon, Florida, United States
- Cape Coral, Florida, United States
- Clearwater, Florida, United States
- Clearwater, Florida, United States
- Jacksonville, Florida, United States
- Lake City, Florida, United States
- Miami, Florida, United States
- Miami, Florida, United States
- Miami, Florida, United States
- Miami, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Naples, Florida, United States
- Ocala, Florida, United States
- Ormond Beach, Florida, United States
- Plantation, Florida, United States
- Sarasota, Florida, United States
- Tamarac, Florida, United States
- + 338 more on CT.gov