Clinical Trials in Mexico / NCT07082738
Recruiting
Phase 2
A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
NCT07082738 · tracked via the Priya Life Science Mexico tracker
Condition(s) studied
Chronic Obstructive Pulmonary Disease (COPD)
Investigational drug(s) / intervention(s)
AZD6793Placebo
AZD6793: Oral dosage
Placebo: Oral dosage
Study summary
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
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.
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Official registry record
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.
View NCT07082738 on ClinicalTrials.gov ↗ ← All trials in Mexico