Language: BG BG
← Back to results
Recruiting Phase 2 NCT07082738

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

Phase 2 – studying effectiveness and dosage
Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Sponsor: AstraZeneca

trial.available_in: БГ
Overview
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.
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.
Who can participate
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.
Locations 23
Argentina (1)
Research Site
Alberdi
Australia (1)
Research Site
Cairns
Bulgaria (1)
Research Site
Dupnitsa
Canada (1)
Research Site
Edmonton , Alberta
Chile (1)
Research Site
Chile
China (1)
Research Site
Baotou
Denmark (1)
Research Site
Aalborg
Greece (1)
Research Site
Athens
Hungary (1)
Research Site
Balassagyarmat
NOT_YET_RECRUITING
India (1)
Research Site
Belagavi
Italy (1)
Research Site
Busto Arsizio
Japan (1)
Research Site
Chiba
Mexico (1)
Research Site
Chihuahua City
NOT_YET_RECRUITING
Peru (1)
Research Site
Lima
NOT_YET_RECRUITING
Poland (1)
Research Site
Bialystok
South Korea (1)
Research Site
Anyang-si
Spain (1)
Research Site
Benalmádena
Taiwan (1)
Research Site
Changhua
Turkey (1)
Research Site
Adana
Ukraine (1)
Research Site
Chernivtsi
United Kingdom (1)
Research Site
Bradford
United States (1)
Research Site
Birmingham , Alabama
Vietnam (1)
Research Site
Da Nang
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
40 Years
Healthy volunteers
No
Start date
27.06.2025
Completion date
05.11.2027
Registry ID
NCT07082738
Source
anzctr
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.