A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
PHASE2RECRUITING
This Phase IIb dose-ranging study will evaluate the efficacy and safety of 3 different doses of AZD6793 compared with placebo tablets in participants with moderate to very severe chronic obstructive pulmonary disease.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Participant must be ≥40 years of age at the time of signing the informed consent.
- Documented primary diagnosis of moderate to very severe 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 remain exacerbation free at 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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE2
Study ID
NCT07082738
Intervention or treatment
DRUG: AZD6793
OTHER: Placebo
Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
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Research sites nearby
Closest Location:
Research Site
Select from list below to view details:
Research Site
Cairns, Australia
Research Site
Norwood, Australia
Research Site
Osborne Park, Australia
Research Site
South Brisbane, Australia
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Who is running the clinical trial?
A
AstraZeneca
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Dose 1 of AZD6793
| Drug: AZD6793 |
EXPERIMENTAL: Dose 2 of AZD6793
| Drug: AZD6793 |
PLACEBO_COMPARATOR: Matching Placebo
| Other: Placebo |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From baseline up to 24 Weeks |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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 | From baseline to Week 4, Week 12 and Week 24 |
Are you running this trial?If you're a clinic or sponsor, you can claim this study.
References
Clinical Trials Gov: A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary DiseaseOther trials to consider
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