A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Other: Placebo
- Registration Number
- NCT07082738
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
A Multicentre, Parallel-group, Phase IIb, Randomised, Double-blind, Placebo-controlled, 4-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 400 sites globally will participate in this study. Approximately 1160 participants will be randomized to four treatment groups; three different doses of AZD6793 vs placebo in a 1:1:1:1 ratio.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1160
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose 1 of AZD6793 AZD6793 Approximately 290 participants will be randomized to receive Dose 1 of AZD6793 Dose 2 of AZD6793 AZD6793 Approximately 290 participants will be randomized to receive Dose 2 of AZD6793 Dose 3 of AZD6793 AZD6793 Approximately 290 participants will be randomized to receive Dose 3 of AZD6793 Matching Placebo Placebo Approximately 290 participants will be randomized to receive Matching Placebo
- Primary Outcome Measures
Name Time Method Annualised rate of moderate or severe COPD exacerbations From baseline up to 24 Weeks The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 24 Weeks treatment period compared to placebo
- Secondary Outcome Measures
Name Time Method Time to first moderate or severe COPD exacerbation From baseline up to 24 Weeks To evaluate the effect of AZD6793 as compared to placebo on COPD exacerbations from baseline up to 24 Weeks
Annualised rate of COPD exacerbations associated with emergency room visits, urgent care visits, or hospitalisations From baseline up to 24 Weeks To evaluate the effect of AZD6793 as compared to placebo on COPD exacerbations from baseline up to 24 Weeks
Annualised rate of severe COPD exacerbations From baseline up to 24 Weeks To evaluate the effect of AZD6793 as compared to placebo on COPD exacerbations from baseline up to 24 Weeks
Annualised rate of COPDCompEx events From baseline up to 24 Weeks To evaluate the effect of AZD6793 as compared to placebo on COPDCompEx events from baseline up to 24 Weeks
Time to first COPDCompEx event From baseline up to 24 Weeks To evaluate the effect of AZD6793 as compared to placebo on COPDCompEx events from baseline up to 24 Weeks
Change from baseline in pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) From baseline to Week 12 and Week 24 Change from baseline in pre-BD FEV1 at Week 12 and Week 24 compared to placebo
Change from baseline in post-bronchodilator (post-BD) forced expiratory volume in 1 second (FEV1) From baseline to Week 12 and Week 24 Change from baseline in post-BD FEV1 at Week 12 and Week 24 compared to placebo
Change from baseline in Breathlessness, Cough and Sputum Scale (BCSS) total score From baseline over 24 Weeks 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.Change from baseline in COPD Assessment Test (CAT) total score From baseline over 24 Weeks 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.Change from baseline in St George's Respiratory Questionnaire (SGRQ) total and domain scores From baseline over 24 Weeks 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.Measurement of plasma concentrations of AZD6793 at specific timepoints From baseline to Week 4, Week 12 and Week 24 To assess the pharmacokinetics (PK) of AZD6793 in participants with moderate to very severe COPD
Trial Locations
- Locations (1)
Research Site
🇻🇳Hue, Vietnam
Research Site🇻🇳Hue, Vietnam