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Looking for participantsPhase2

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

Sponsor: AstraZeneca

NCT ID: NCT07082738

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
AZD6793 (drug), Placebo (other)
How long the study runs
Study runs about 29 months (dates as stated)
About the drug or intervention
AZD6793 — drug: Oral dosage · Placebo — other: Oral dosage
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
40 Years and over
Who
All
Number of participants
987
Started
2025-06-27
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for chronic obstructive pulmonary disease (copd)
  • • Phase2 - 987 participants
  • • 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

Who can take part?

  • • Ages 40 Years and over
  • • Diagnosed with chronic obstructive pulmonary disease (copd)

Where?

  • • Bradford - Research Site
  • • Cottingham - Research Site
  • • Glasgow - Research Site
  • • Harrow - Research Site
  • • +5 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

A Multicentre, Parallel-group, Phase IIb, Randomised, Double-blind, Placebo-controlled, 3-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) Approximately 350 sites globally will participate in this study. Approximately 970 participants will be randomized to AZD6793 or Placebo. Following CSP V.3.0, participants will be randomized in a 1:1:1 ratio of two doses of AZD6793 vs Placebo.

Chronic Obstructive Pulmonary Disease (COPD)

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 40 Years and over
  • Who can join: All genders

Biomarkers mentioned

test positive

What the study is looking for

  • ✓Participant must be ≥40 years of age at the time of signing the agreement to take part.
  • ✓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...
  • ✓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...

Who cannot take part

  • ✗Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the...
  • ✗Significant left heart failure.
  • ✗lung 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...
See the full 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 Is This Study? (9 UK sites)

Research Site

Bradford BD9 6RJ, United Kingdom

Recruiting

Research Site

Cottingham HU16 5JQ, United Kingdom

Recruiting

Research Site

Glasgow G4 0SF, United Kingdom

Recruiting

Research Site

Harrow HA1 3UJ, United Kingdom

ACTIVE_NOT_RECRUITING

Research Site

London EC1M 6BQ, United Kingdom

Recruiting

Research Site

London NW3 2QG, United Kingdom

COMPLETED

Research Site

Newcastle upon Tyne NE1 4LP, United Kingdom

Recruiting

Research Site

Thetford IP24 1JD, United Kingdom

Recruiting

Research Site

Wythenshawe M23 9QZ, United Kingdom

ACTIVE_NOT_RECRUITING

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09