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Набира участници Фаза 2 NCT07082738

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

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Chronic Obstructive Pulmonary Disease (COPD)

Спонсор: AstraZeneca

Налично на: БГ
Обобщение
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.
Описание
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.
Кой може да участва
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.
Места на провеждане 23
Argentina (1)
Research Site
Alberdi
Австралия (1)
Research Site
Cairns
България (1)
Research Site
Dupnitsa
Канада (1)
Research Site
Edmonton , Alberta
Chile (1)
Research Site
Chile
Китай (1)
Research Site
Baotou
Дания (1)
Research Site
Aalborg
Гърция (1)
Research Site
Athens
Унгария (1)
Research Site
Balassagyarmat
NOT_YET_RECRUITING
Индия (1)
Research Site
Belagavi
Италия (1)
Research Site
Busto Arsizio
Япония (1)
Research Site
Chiba
Mexico (1)
Research Site
Chihuahua City
NOT_YET_RECRUITING
Peru (1)
Research Site
Lima
NOT_YET_RECRUITING
Полша (1)
Research Site
Bialystok
Южна Корея (1)
Research Site
Anyang-si
Испания (1)
Research Site
Benalmádena
Taiwan (1)
Research Site
Changhua
Турция (1)
Research Site
Adana
Ukraine (1)
Research Site
Chernivtsi
Великобритания (1)
Research Site
Bradford
САЩ (1)
Research Site
Birmingham , Alabama
Vietnam (1)
Research Site
Da Nang
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
40 Years
Здрави доброволци
Не
Начална дата
27.06.2025
Крайна дата
05.11.2027
Регистрационен номер
NCT07082738
Източник
anzctr
Запитване за медицински туризъм

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