Идёт набор NCT07082738

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

Фаза II С лечением Chronic Obstructive Pulmonary Disease (COPD)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: AZD6793, Placebo.
Кому может быть актуально: Состояния в реестре: Chronic Obstructive Pulmonary Disease (COPD). Базовые параметры: от 40 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Аргентина, Австралия, Болгария, Канада +19
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

Препарат AZD6793
Oral dosage
Другое Placebo
Oral dosage

Первичные конечные точки

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

Вторичные конечные точки (11)

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

Критерии участия

Критерии включения

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).

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение: Рандомизированное
Модель: Параллельные группы
Маскирование: Четверное слепое
Основная цель: Лечение