Chronic Obstructive Pulmonary Disease study: AZD6793
Official title A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
ClinicalTrials.gov ID: NCT07082738
What this study is testing
What is AZD6793?
This is an investigational oral tablet being studied as a potential treatment for chronic obstructive pulmonary disease (COPD).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether AZD6793 helps people with moderate to very severe COPD. It also looks at how safe the drug is.
- Who it's for
- You may join if you have moderate to very severe COPD and meet the study criteria.
- What's involved
- You would take a tablet of AZD6793 or a pretend tablet. You will have visits and tests to check your breathing and safety.
- Time commitment
- The study lasts about 12 weeks, with several visits to give the tablets and have tests.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- 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.
You likely can't join if
- Clinically important pulmonary disease other than COPD (eg, asthma [current diagnosis per GINA or other accepted guidelines], active pulmonary...
- Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant's respiratory...
- Any unstable disorder, including, but not limited to, CV, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine...
- Significant left heart failure.
- Unstable angina, acute coronary syndrome/acute myocardial infarction or coronary intervention with percutaneous coronary intervention/coronary artery...
- Pulmonary arterial hypertension, either idiopathic or due to connective tissue or thromboembolic disease.
See the full eligibility 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).
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Norco, California, United States
- Brandon, Florida, United States
- Cape Coral, Florida, United States
- Clearwater, Florida, United States
- Lake City, 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
- Tampa, Florida, United States
- Winter Park, Florida, United States
- Zachary, Louisiana, United States
+ 228 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Phoenix, Arizona, United States; Los Angeles, California, United States; Newport Beach, California, United States; Norco, California, United States; Brandon, Florida, United States and 242 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.