🔎 Trials Near Me

Home › COPD › NCT07082738

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

RecruitingPhase 2

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)

Who can join

Ages 40 and older · All sexes

Full eligibility 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.

About the study

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.

What is being tested

Sponsor: AstraZeneca · Participants: 987 · Started: Jun 27, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07082738

Locations in the U.S.

AlabamaResearch Site, Birmingham
ArizonaResearch Site, Phoenix
Research Site, Phoenix
Research Site, Phoenix
CaliforniaResearch Site, Los Angeles
Research Site, Newport Beach
Research Site, Norco
FloridaResearch Site, Brandon
Research Site, Cape Coral
Research Site, Clearwater
Research Site, Clearwater
Research Site, Lake City
Research Site, Miami
Research Site, Miami
Research Site, Miami
Research Site, Miami
Research Site, Miami
Research Site, Miami Lakes
Research Site, Naples
Research Site, Ocala
Research Site, Ormond Beach
Research Site, Plantation
Research Site, Sarasota
Research Site, Tamarac
Research Site, Tampa
Research Site, Tampa
Research Site, Winter Park
LouisianaResearch Site, Zachary
MarylandResearch Site, Baltimore
Research Site, Baltimore
MassachusettsResearch Site, Burlington
MichiganResearch Site, Farmington Hills
Research Site, Garden City
Research Site, Grand Rapids
MissouriResearch Site, Chesterfield
Research Site, Hannibal
Research Site, St Louis
Research Site, St Louis
MontanaResearch Site, Missoula
New YorkResearch Site, Mount Kisco
North CarolinaResearch Site, New Bern
OhioResearch Site, Cleveland
Research Site, Marion
OklahomaResearch Site, Oklahoma City
Research Site, Tulsa
OregonResearch Site, Medford
Research Site, Portland
PennsylvaniaResearch Site, Camp Hill
Research Site, DuBois
Research Site, Philadelphia
Research Site, Philadelphia
Research Site, Pittsburgh
Research Site, Scottdale
Research Site, Smithfield
South CarolinaResearch Site, Lancaster
Research Site, Spartanburg
South DakotaResearch Site, Rapid City
TennesseeResearch Site, Chattanooga
Research Site, Franklin
TexasResearch Site, Boerne
Research Site, Dallas
Research Site, Denison
Research Site, El Paso
Research Site, Houston
Research Site, Lewisville
Research Site, Mansfield
Research Site, McKinney
VermontResearch Site, Colchester
VirginiaResearch Site, Norfolk
Research Site, Williamsburg
West VirginiaResearch Site, Morgantown
WisconsinResearch Site, Madison

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.