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)
Annualised rate of moderate or severe COPD exacerbations — From baseline up to 24 Weeks The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 24 Weeks treatment period compared to placebo
Trial sites (367)
Facility
City
Region
Status
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.
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.
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