A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Launched by ASTRAZENECA · Jul 16, 2025
Trial Information
Current as of September 12, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medicine called AZD6793 to see if it can help people with moderate to very severe chronic obstructive pulmonary disease (COPD), a lung condition that makes it hard to breathe. The study will compare different doses of AZD6793 to a placebo (a pill with no medicine) to check how well it works and if it is safe for patients.
People who might be eligible to join are adults aged 40 or older who have had COPD for at least a year and have experienced recent flare-ups of their symptoms. They should already be on regular inhaled treatments for COPD and have a history of smoking. Participants need to be in stable condition without recent worsening of their symptoms. During the trial, participants will take one of the study pills and have their health monitored closely to see how the medicine affects their breathing and overall well-being. This study is currently looking for volunteers, and those interested should talk to their doctor to see if they qualify.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Participant must be ≥40 years of age at the time of signing the informed consent.
- • Documented primary diagnosis of moderate to very severe 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 remain exacerbation free at 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.
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Sofia, Bulgaria
Stara Zagora, Bulgaria
Medford, Oregon, United States
El Paso, Texas, United States
Cleveland, Ohio, United States
Napoli, Italy
Veliko Tarnovo, Bulgaria
Oklahoma City, Oklahoma, United States
Esbjerg, Denmark
Málaga, Spain
Sarasota, Florida, United States
Cottingham, United Kingdom
Baltimore, Maryland, United States
Pittsburgh, Pennsylvania, United States
Tamarac, Florida, United States
Debrecen, Hungary
Bydgoszcz, Poland
Birmingham, Alabama, United States
Los Angeles, California, United States
Saint Louis, Missouri, United States
Kalispell, Montana, United States
New Bern, North Carolina, United States
Spartanburg, South Carolina, United States
Haskovo, Bulgaria
Plovdiv, Bulgaria
Sherbrooke, Quebec, Canada
Hvidovre, Denmark
Roskilde, Denmark
Marburg, Germany
Pavia, Italy
Bradford, United Kingdom
Harrow, United Kingdom
Glendale, Arizona, United States
Ormond Beach, Florida, United States
Ocala, Florida, United States
Mckinney, Texas, United States
Ajax, Ontario, Canada
Chattanooga, Tennessee, United States
Tampa, Florida, United States
Morgantown, West Virginia, United States
Lexington, Kentucky, United States
Athens, Greece
Ioannina, Greece
Milano, Italy
Newcastle Upon Tyne, United Kingdom
Plantation, Florida, United States
Miami Lakes, Florida, United States
Törökbálint, Hungary
Saskatoon, Saskatchewan, Canada
Winter Park, Florida, United States
South Brisbane, Australia
Madrid, Spain
Franklin, Tennessee, United States
Johnson City, Tennessee, United States
Clearwater, Florida, United States
Naples, Florida, United States
Burlington, Ontario, Canada
Shanghai, China
Taichung, Taiwan
Burlington, Massachusetts, United States
West Des Moines, Iowa, United States
Grand Rapids, Michigan, United States
Newport Beach, California, United States
Mount Kisco, New York, United States
Mansfield, Texas, United States
Madison, Wisconsin, United States
Taipei, Taiwan
Durango, Mexico
Roma, Italy
La Mesa, California, United States
Tustin, California, United States
Jacksonville, Florida, United States
Philadelphia, Pennsylvania, United States
San Miguel De Tucuman, Argentina
Hangzhou, China
Elbląg, Poland
Changhua, Taiwan
Kaohsiung, Taiwan
Glasgow, United Kingdom
Aalborg, Denmark
Busto Arsizio, Italy
Rapid City, South Dakota, United States
Boerne, Texas, United States
Marion, Ohio, United States
Camp Hill, Pennsylvania, United States
Houston, Texas, United States
Edmonton, Alberta, Canada
Witten, Germany
Kingwood, Texas, United States
Changchun, China
Pozuelo De Alarcon, Spain
Thessaloniki, Greece
Odense C, Denmark
Monza, Italy
Miami, Florida, United States
Mar Del Plata, Argentina
Wollongong, Australia
Dupnitsa, Bulgaria
Yambol, Bulgaria
Quebec, Canada
Cheongju Si, Korea, Republic Of
Katowice, Poland
Hanoi, Vietnam
Ho Chi Minh City, Vietnam
Brandon, Florida, United States
Rosario, Argentina
Bursa, Turkey
Ivano Frankivsk, Ukraine
Ho Chi Minh, Vietnam
Edelény, Hungary
Suwanee, Georgia, United States
Tulsa, Oklahoma, United States
Kyiv, Ukraine
Kyiv, Ukraine
London, United Kingdom
Santander, Spain
Portland, Oregon, United States
Daegu, Korea, Republic Of
Taoyuan, Taiwan
Zachary, Louisiana, United States
Farmington Hills, Michigan, United States
Scottdale, Pennsylvania, United States
Smithfield, Pennsylvania, United States
St Charles Borromee, Quebec, Canada
Ranelagh, Argentina
Santiago, Chile
Wonju Si, Korea, Republic Of
Rzeszów, Poland
Kayseri, Turkey
Lakewood, Colorado, United States
Gödöllő, Hungary
Berlin, Germany
Karczew, Poland
Phoenix, Arizona, United States
Piaseczno, Poland
Hajdúnánás, Hungary
Kochi Shi, Japan
Victoriaville, Quebec, Canada
Seoul, Korea, Republic Of
Lutsk, Ukraine
Białystok, Poland
Mersin, Turkey
Landsberg, Germany
Hue, Vietnam
łódź, Poland
Yokohama Shi, Japan
Guadalajara, Mexico
Hannover, Germany
Lübeck, Germany
Schleswig, Germany
Poznań, Poland
Pearland, Texas, United States
Aarhus, Denmark
Anyang Si, Korea, Republic Of
Santiago, Chile
Adana, Turkey
Lancaster, South Carolina, United States
Lewisville, Texas, United States
Williamsburg, Virginia, United States
Cairns, Australia
Truro, Nova Scotia, Canada
Huhehaote, China
Linhai, China
Darmstadt, Germany
Halle, Germany
Rosenheim, Germany
Trois Rivières, Quebec, Canada
Fukuoka Shi, Japan
Ginowan Shi, Japan
Canoga Park, California, United States
Dubois, Pennsylvania, United States
Uzhhorod, Ukraine
Denison, Texas, United States
Cuneo, Italy
Wuhan, China
Lake City, Florida, United States
Zhengzhou, China
Benalmádena, Spain
Kumamoto Shi, Japan
Ube, Japan
Wiesbaden, Germany
Ksawerów, Poland
Fuzhou, China
Wythenshawe, United Kingdom
Viña Del Mar, Chile
Szczecin, Poland
Norco, California, United States
Mar Del Plata, Argentina
Encs, Hungary
Baotou, China
Chihuahua, Mexico
Chesterfield, Missouri, United States
Hannibal, Missouri, United States
Winnipeg, Manitoba, Canada
Hachioji Shi, Japan
Jeonju, Korea, Republic Of
Ostróda, Poland
Colchester, Vermont, United States
Guelph, Ontario, Canada
Shenyang, China
Thetford, United Kingdom
Chengdu, China
Yung Kang City, Taiwan
Norfolk, Virginia, United States
Cape Coral, Florida, United States
Taipei City, Taiwan
Chęciny, Poland
Da Nang, Vietnam
Statte, Italy
Telese Terme, Italy
Alberdi, Argentina
Capital Federal, Argentina
Merida, Spain
Talca, Chile
Monterrey, Mexico
Płock, Poland
Temuco, Chile
Lima, Peru
Kamakura, Japan
Nyíregyháza Sóstóhegy, Hungary
Ankara, Turkey
Leipzig, Germany
Ahrensburg, Germany
Obertshausen, Germany
Izmit, Turkey
Taichung City, Taiwan
Dallas, Texas, United States
Hamilton, Ontario, Canada
Norwood, Australia
Bendorf, Germany
Garden City, Michigan, United States
Chile, Chile
Osborne Park, Australia
Buenos Aires, Argentina
Mendoza, Argentina
Granollers, Spain
Budapest, Hungary
Warszawa, Poland
Stoney Creek, Ontario, Canada
Concepcion, Chile
Chuncheon Si, Korea, Republic Of
Seongnam Si, Korea, Republic Of
Mexico City, Mexico
Komorniki, Poland
Beijing, China
Victoriaville, Quebec, Canada
Wuhan City, China
Patients applied
Trial Officials
Dave Singh, MD
Principal Investigator
Medicines Evaluation Unit, Manchester University NHS Foundations Trust, Manchester, United Kingdom
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported