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AZD6793 for people with moderate to very severe COPD

A Multicentre, Parallel-group, Phase IIb, Randomised, Double-blind, Placebo-controlled, 4-Arm, 24-Week Study to Evaluate the Efficacy and Safety of AZD6793 Tablets in Adult Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (PRESTO)

Phase 2 Interventional AstraZeneca · NCT07082738

This trial will test three different doses of the oral medicine AZD6793 against a placebo in adults with moderate to very severe COPD to see if it improves symptoms and reduces flare-ups.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment1160 (estimated)
Ages40 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Locations363 sites (Birmingham, Alabama and 362 other locations)
Trial IDNCT07082738 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 40 or older with documented moderate to very severe COPD, a history of at least two moderate or one severe exacerbation in the past year, a CAT score ≥10, and on stable inhaled dual or triple maintenance therapy are the intended participants.

Not a fit: People with mild COPD, those with recent or unstable exacerbations, pregnant women, or patients excluded for medical comorbidities are unlikely to benefit from or be eligible for this trial.

Why it matters

Potential benefit: If successful, AZD6793 could reduce COPD exacerbations and improve breathing and symptoms for patients who remain symptomatic on current inhaled therapies.

How similar studies have performed: Other phase II dose-ranging trials in COPD have shown mixed results for new oral or inhaled agents, and AZD6793 remains experimental with its effect not yet proven in large trials.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Birmingham, Alabama and 362 other locations

+313 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Obstructive Pulmonary DiseaseCOPDModerate COPDSevere COPDVery Severe COPDchronic obstructive pulmonary diseaseAZD6793IRAK4
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.