What is AZD6793 studying for chronic obstructive pulmonary disease (COPD)?

AZD6793 is being studied to evaluate its effect on adults with moderate to very severe COPD. The trial compares two doses of AZD6793 to placebo to understand its impact on COPD exacerbations and lung function. AstraZeneca is leading this research to explore potential treatment options for COPD.

Who may be eligible for this chronic obstructive pulmonary disease (COPD) clinical trial?

Adults aged 40 years or older with a diagnosis of COPD for at least 12 months may be eligible. Participants must have a history of moderate or severe exacerbations, be on stable inhaled maintenance therapy, and have a significant smoking history. Please review eligibility criteria for more details.

Is there any cost to participate in this chronic obstructive pulmonary disease (COPD) clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Age: 40Years +

All Genders

ID07082738

Phase IIb Study of AZD6793 Tablets to Treat Moderate to Very Severe Chronic Obstructive Pulmonary Disease in Adults

Led by AstraZeneca · Updated on 2026-08-11

987

Participants Needed

368

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effect of AZD6793, an oral medication, in adults with moderate to very severe chronic obstructive pulmonary disease COPD. This Phase IIb, randomized, double-blind, placebo-controlled study involves approximately 970 participants across about 350 global sites. The trial aims to compare the efficacy and safety of two different doses of AZD6793 against placebo over a 24-week period. Participants will be randomly assigned to one of three groups receiving either dose 1 of AZD6793, dose 2 of AZD6793, or a matching placebo tablet. The study medication is taken orally and the trial lasts for 24 weeks. The study is designed as a parallel-group format with a 111 allocation ratio among the three arms. During the study, participants will be monitored through various assessments including lung function tests measuring forced expiratory volume FEV1, questionnaires evaluating breathlessness, cough, sputum, and quality of life, and tracking of COPD exacerbation events. Blood samples will be collected to measure plasma concentrations of AZD6793. Safety and efficacy outcomes will be evaluated up to 24 weeks, with the main outcome being the rate of moderate or severe COPD exacerbations.

CONDITIONS

Brief Title

A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Who Can Participate

Age: 40Years +

All Genders

Eligibility Criteria

You may qualify if you...

Participant must be 40 years of age or older at the time of signing the informed consent.
Documented primary diagnosis of COPD for at least 12 months before enrollment.
Pre-bronchodilator FEV1/FVC ratio less than 0.7 at Visit 1.
Pre- and post-bronchodilator FEV1/FVC ratio less than 0.7, and post-bronchodilator FEV1 between 25% and less than 80% of predicted normal at Visit 2.
History of 2 or more moderate or at least 1 severe COPD exacerbations in the 12 months before screening.
Stable regimen of inhaled triple or dual maintenance therapy for 3 months or more before screening.
COPD Assessment Test (CAT) score of 10 or higher at Visit 1.
Current or former smokers with a smoking history of at least 10 pack-years.
Clinically stable and free from COPD exacerbation for at least 4 weeks before Visit 1 and Visit 3 (randomisation).
Negative pregnancy test at Visits 1 and 3 for women of child-bearing potential.

You will not qualify if you...

Presence of significant pulmonary diseases other than COPD, such as current asthma, active pulmonary infection, predominant bronchiectasis, pulmonary fibrosis, cystic fibrosis, obesity-related hypoventilation syndrome, lung cancer, alpha-1 antitrypsin deficiency, or primary ciliary dyskinesia.
Radiological evidence of other respiratory diseases significantly affecting symptoms.
Unstable disorders including cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric conditions, or major physical/cognitive impairment.
Significant left heart failure.
Unstable angina, recent acute coronary syndrome or myocardial infarction, recent coronary interventions, uncontrolled arrhythmia, cardiomyopathy, severe aortic stenosis, or signs of pulmonary edema or volume overload.
Pulmonary arterial hypertension of any cause.
History of conditions that increase infection risk.
History of ulcerative colitis, Crohn's disease, or microscopic colitis.
Abnormal laboratory results.
Evidence of active or chronic liver disease.
History or positive test for HIV infection.
History of lung volume reduction surgery.
Current or past malignancy within 5 years prior to screening.

Research Team

AstraZeneca Clinical Study Information Center

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Phase IIb Study of AZD6793 Tablets to Treat Moderate to Very Severe Chronic Obstructive Pulmonary Disease in Adults

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria