Last updated 7 days ago
A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
987 patients around the world
Available in Chile, Peru, Argentina, United States, Mexico
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.
AstraZeneca
6Research sites
987Patients around the world
This study is for people with
Chronic obstructive pulmonary disease
Moderate/severe copd
Requirements for the patient
From 40 Years
All Gender
Medical requirements
- 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.
Sites
Clínica 25 de Mayo - Mar del Plata
Recruiting
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
Instituto de Especialidades de la Salud Rosario Clínica del Tórax
Recruiting
Clínica Mayo de UMCB SRL - Tucumán
Recruiting
Fundación Enfisema - Instituto Ave Pulmo
Recruiting
CEDIC Centro de Investigación Clínica - CABA, Buenos Aires
Recruiting
StudyPRESTO
SponsorAstraZeneca
Study typeInterventional
Conditions
Moderate/severe copd
Requirements
From 40 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07082738
