Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
Intervention name: AZD6793
Description: AZD6793 administered oraly throughout the study.
Intervention Name: Placebo
Description: Placebo administered oraly throughout the study.
Sponsors
Ageishi Yuji
Eligibility
Sex/Gender
All
Inclusion 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 _ 25% to _ 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
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. "
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualised rate of moderate or severe COPD exacerbations | — |
Countries
Argentina, Australia, Bulgaria, Canada, Chile, China, Denmark, Germany, Greece, Hungary, India, Italy, Japan, Mexico, Peru, Poland, South Korea, Spain, Taiwan, Turkey, UK, Ukraine, US, Vietnam
Contacts
Public ContactYuji Ageishi
Astrazeneka K.K
Outcome results
None listed