Recruiting NCT07082738

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

Phase II Interventional Chronic Obstructive Pulmonary Disease (COPD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: AZD6793, Placebo.
Who it may be relevant to: Registry conditions: Chronic Obstructive Pulmonary Disease (COPD). Basic parameters: from 40 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Bulgaria, Canada +19
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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.

Detailed description

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.

Interventions

Drug AZD6793
Oral dosage
Other Placebo
Oral dosage

Primary outcome measures

Annualised rate of moderate or severe COPD exacerbations [Time frame: From baseline up to 24 Weeks]

Secondary outcome measures (11)

Time to first moderate or severe COPD exacerbation [Time frame: From baseline up to 24 Weeks]
Annualised rate of COPD exacerbations associated with emergency room visits, urgent care visits, or hospitalisations [Time frame: From baseline up to 24 Weeks]
Annualised rate of severe COPD exacerbations [Time frame: From baseline up to 24 Weeks]
Annualised rate of COPDCompEx events [Time frame: From baseline up to 24 Weeks]
Time to first COPDCompEx event [Time frame: From baseline up to 24 Weeks]
Change from baseline in pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) [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) [Time frame: From baseline to Week 12 and Week 24]
Change from baseline in Breathlessness, Cough and Sputum Scale (BCSS) total score [Time frame: From baseline over 24 Weeks]
Change from baseline in COPD Assessment Test (CAT) total score [Time frame: From baseline over 24 Weeks]
Change from baseline in St George's Respiratory Questionnaire (SGRQ) total and domain scores [Time frame: From baseline over 24 Weeks]
Measurement of plasma concentrations of AZD6793 at specific timepoints [Time frame: From baseline to Week 4, Week 12 and Week 24]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment