Testing AZD6793 against a placebo for chronic obstructive pulmonary disease (COPD)
Official title: A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
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)
- Phase 2
- 3 groups
- Sites in Edmonton, Winnipeg and 12 more cities
- Recruiting
Interventions
- Medication
AZD6793
Oral dosage
- Other intervention
Placebo
Oral dosage
Canadian Sites (15)
14 of 15 recruiting
- Recruiting
Research Site
Winnipeg, Manitoba
- Recruiting
Research Site
Truro, Nova Scotia
- Recruiting
Research Site
Ajax, Ontario
- Recruiting
Research Site
Burlington, Ontario
- Recruiting
Research Site
Guelph, Ontario
- Recruiting
Research Site
Hamilton, Ontario
- Recruiting
Research Site
Stoney Creek, Ontario
- Recruiting
Research Site
Québec, Quebec
- Recruiting
Research Site
Saint-Charles-Borromée, Quebec
- Recruiting
Research Site
Sherbrooke, Quebec
- Recruiting
Research Site
Trois-Rivières, Quebec
- Recruiting
Research Site
Trois-Rivières, Quebec
- Recruiting
Research Site
Victoriaville, Quebec
- Recruiting
Research Site
Saskatoon, Saskatchewan
- Withdrawn
Research Site
Edmonton, Alberta
Eligibility Criteria
See who this study is looking for22 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Participant must be ≥40 years of age at the time of signing the informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +Documented primary diagnosis of COPD for at least 12 months prior to enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
- +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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- +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.
- +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 (randomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →).
- +Negative pregnancy test at Visit 1 and Visit 3 for Women Of Child-Bearing Potential (WOCBP).
- +Current or ex-smokers with a cigarette smoking history of ≥ 10 pack-years.
Exclusion
- −Participants with history of HIV infection or who test positive for HIV.
- −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 randomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →, 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.
- −Current or history of malignancy within 5 years before the screening visitScreeningThe checks done before joining, to see whether a study fits.Read more →.
- −History of lung volume reduction surgery.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Groups A and B receive AZD6793.
Registry label: A: Dose 1 of AZD6793 · B: Dose 2 of AZD6793
Group C, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.
Registry label: C: Matching Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 40 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 987 people.
The study is currently expected to finish around November 2027.
The main measurement is taken over: From baselineBaselineYour starting measurements, taken before treatment begins.Read more → up to 24 Weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Annualised rate of moderate or severe COPD exacerbations — measured over From baselineBaselineYour starting measurements, taken before treatment begins.Read more → up to 24 Weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07082738 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About AZD6793Drug
Oral dosage
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboOther
Oral dosage
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 40 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 40 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From baselineBaselineYour starting measurements, taken before treatment begins.Read more → up to 24 Weeks.
The study as a whole is currently expected to finish around 2027-11-05.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 987 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 19 locations, including: Edmonton, Alberta, Canada; Winnipeg, Manitoba, Canada; Truro, Nova Scotia, Canada; Ajax, Ontario, Canada; Burlington, Ontario, Canada; Guelph, Ontario, Canada, and 13 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
Other Sites (5)
Research Site
Farmington Hills, Michigan, United States
Research Site
Garden City, Michigan, United States
Research Site
Grand Rapids, Michigan, United States
Research Site
Missoula, Montana, United States
Research Site
Mount Kisco, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.