AZD6793 for people with moderate to very severe COPD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicentre, randomized, double-blind, placebo-controlled Phase IIb trial that will compare three doses of AZD6793 with placebo over 24 weeks. Approximately 1,160 adults aged 40 and over with moderate to very severe COPD and a recent history of exacerbations will be randomized 1:1:1:1 across about 400 global sites. Participants must be on stable inhaled maintenance therapy and meet lung function and symptom criteria at screening. The study will collect data on efficacy outcomes (lung function, symptoms, and exacerbations) and safety across the four treatment groups.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  Birmingham, Alabama, United States Recruiting
• Research Site
  Phoenix, Arizona, United States Recruiting
• Research Site
  Phoenix, Arizona, United States Recruiting
• Research Site
  Phoenix, Arizona, United States Recruiting
• Research Site
  Los Angeles, California, United States Recruiting
• Research Site
  Newport Beach, California, United States Recruiting

+317 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Dave Singh, MD — Medicines Evaluation Unit, Manchester University NHS Foundations Trust, Manchester, United Kingdom
• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.