A Phase 2 interventional study of AZD6793 and Placebo in Chronic Obstructive Pulmonary Disease (COPD), sponsored by AstraZeneca. Recruiting at 367 sites in 24 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
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.
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.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 987 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Approximately 290 participants will be randomized to receive Dose 1 of AZD6793
Drug: AZD6793
Approximately 290 participants will be randomized to receive Dose 2 of AZD6793
Drug: AZD6793
Approximately 290 participants will be randomized to receive Matching Placebo
Other: Placebo
Oral dosage
Oral dosage
Annualised rate of moderate or severe COPD exacerbations
The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 24 Weeks treatment period compared to placebo
Time frame: From baseline up to 24 Weeks
Time to first moderate or severe COPD exacerbation
To evaluate the effect of AZD6793 as compared to placebo on COPD exacerbations from baseline up to 24 Weeks
Time frame: From baseline up to 24 Weeks
Annualised rate of COPD exacerbations associated with emergency room visits, urgent care visits, or hospitalisations
To evaluate the effect of AZD6793 as compared to placebo on COPD exacerbations from baseline up to 24 Weeks
Time frame: From baseline up to 24 Weeks
Annualised rate of severe COPD exacerbations
To evaluate the effect of AZD6793 as compared to placebo on COPD exacerbations from baseline up to 24 Weeks
Time frame: From baseline up to 24 Weeks
Annualised rate of COPDCompEx events
To evaluate the effect of AZD6793 as compared to placebo on COPDCompEx events from baseline up to 24 Weeks
Time frame: From baseline up to 24 Weeks
Time to first COPDCompEx event
To evaluate the effect of AZD6793 as compared to placebo on COPDCompEx events from baseline up to 24 Weeks
Time frame: From baseline up to 24 Weeks
Change from baseline in pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1)
Change from baseline in pre-BD FEV1 at Week 12 and Week 24 compared to placebo
Time frame: From baseline to Week 12 and Week 24
Change from baseline in post-bronchodilator (post-BD) forced expiratory volume in 1 second (FEV1)
Change from baseline in post-BD FEV1 at Week 12 and Week 24 compared to placebo
Time frame: From baseline to Week 12 and Week 24
Change from baseline in Breathlessness, Cough and Sputum Scale (BCSS) total score
Change from baseline in BCSS total score over 24 Weeks compared to placebo. The BCSS is a 3-item questionnaire rating breathlessness, sputum, and cough on a 5 point Likert scale from 0 (no symptoms) to 4 (severe symptoms). The BCSS has a scoring range of 0-12 with higher scores indicative of greater COPD impact on health status.
Time frame: From baseline over 24 Weeks
Change from baseline in COPD Assessment Test (CAT) total score
Change from baseline in the CAT total score over 24 weeks CAT is an 8-item PRO that measures the impact of COPD on the health status of patients with COPD. The CAT has a scoring range of 0-40 with higher scores indicative of greater COPD impact on health status.
Time frame: From baseline over 24 Weeks
Change from baseline in St George's Respiratory Questionnaire (SGRQ) total and domain scores
Participants achieving a clinically meaningful improvement from baseline in SGRQ total score (4-point score decrease) over 24 weeks. SGRQ is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with lower scores indicating better health status.
Time frame: From baseline over 24 Weeks
Measurement of plasma concentrations of AZD6793 at specific timepoints
To assess the pharmacokinetics (PK) of AZD6793 in participants with moderate to very severe COPD
Time frame: From baseline to Week 4, Week 12 and Week 24
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Showing the first 100 of 367 sites across 24 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: AZD6793
Pulmonary Disease, Chronic Obstructive →