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New treatment option for Chronic Obstructive Pulmonary Disease (COPD)
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?
AZD6793 is an investigational medicine, given as a pill taken by mouth, 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 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.
- 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's taking place
- Birmingham, Alabama, United States
- Glendale, 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
- Jacksonville, 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
+ 279 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 - 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?
Study sites include Birmingham, Alabama, United States; Glendale, Arizona, United States; Phoenix, Arizona, United States; Canoga Park, California, United States; La Mesa, California, United States; Los Angeles, California, United States and 293 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.