Идёт набор NCT07073950

A Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation

Фаза IV С лечением Chronic Obstructive Pulmonary Disease Hyperinflation

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: Budesonide/Glycopyrronium/Formoterol Fumarate, Placebo, Metered dose inhaler.
Кому может быть актуально: Состояния в реестре: Chronic Obstructive Pulmonary Disease, Hyperinflation. Базовые параметры: 40 лет — 80 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: Германия, Великобритания
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 Randomised, Double-blind, Multi-centre, Placebo-controlled, Crossover Study to Assess the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler on Cardiac and Lung Function in Participants With Chronic Obstructive Pulmonary Disease and Hyperinflation

Обзор

The purpose of the study is to evaluate the effect of BGF MDI compared with placebo MDI on cardiac and lung function when administered in participants diagnosed with COPD and hyperinflation.

Подробное описание

This is a Phase IV, randomised, double blind, multiple centre, placebo controlled, crossover study where the effectiveness of BGF MDI in comparison with matching placebo MDI on cardiac and lung function will be evaluated in patients with COPD and hyperinflation.

The study will comprise of:

* Screening period * Participants will receive placebo inhaler and salbutamol before randomization * Two treatment periods of 21 days each, where participants will be randomized 1:1 to receive either the study intervention BGF metered-dose inhaler (MDI) or placebo in Period 1 then crossover to matching placebo or BGF in Period 2 * A final follow-up period

Вмешательства

Препарат Budesonide/Glycopyrronium/Formoterol Fumarate
BGF will be administered as 2 inhalations via oral route of administration
Препарат Placebo
Matching placebo will be administered as 2 inhalations via oral route of administration
Устройство Metered dose inhaler
Participants will receive BGF and matching placebo via metered dose inhaler in treatment periods of the study.

Первичные конечные точки

Change from baseline in left ventricular end diastolic volume indexed by body surface area (LVEDVi) measured by magnetic resonance imaging (MRI) [Срок оценки: Up to 3 weeks]

Вторичные конечные точки (2)

Change from baseline in functional residual capacity/total lung capacity (FRC/TLC) measured by body plethysmography [Срок оценки: Up to 3 weeks]
Change from baseline in residual volume/total lung capacity (RV/TLC) measured by body plethysmography [Срок оценки: Up to 3 weeks]

Критерии участия

Критерии включения

Current or former smoker with a history of ≥ 10 pack-years of tobacco smoking.
A diagnosis of COPD confirmed by a post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 0.7.
At Visit 1: A pre-bronchodilator FEV1 < 80%.
At Visit 1: Peripheral blood eosinophil count < 300 cells/cubic millimeter (mm³), with no recorded history of eosinophil count > 300 cells/mm³ in the past 12 months.
At Visit 1: Modified Medical Research Council (mMRC) ≥ 1.
At Visit 2: A pre-bronchodilator functional residual capacity (FRC) of > 135% of predicted normal FRC.
At Visit 2: A post-bronchodilator FEV1 ≥ 30% and < 80% of the predicted normal value.
Participants must be on mono-, dual-, or triple-inhaled maintenance COPD treatment.
Female participants must either be not of childbearing potential or using a form of highly effective birth control.
All women of child bearing potential must have a negative pregnancy test at the Visit 1.

Критерии исключения

A current diagnosis of asthma, asthma-COPD overlap, or any other chronic respiratory disease other than COPD, such as alpha-1 antitrypsin deficiency, active tuberculosis, lung cancer, lung fibrosis, sarcoidosis, interstitial lung disease, and pulmonary hypertension.
History of a COPD exacerbation that required hospitalisation, or 2 or more COPD exacerbations that required systemic corticosteroids.
History of myocardial infarction or acute coronary syndrome.
History or current clinically significant atrial or ventricular arrhythmia to be confirmed by electrocardiogram (ECG).
Participants with a cardiac implantable electronic device, including pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy.
Participants with ECG QTcF interval at Visit 1 > 460 milliseconds (ms) for males and > 480 ms for females.
Participants who have had a respiratory tract infection within 8 weeks prior to Visit 1 and/or during the screening/run-in period.
Participants with lung lobectomy, lung volume reduction (during the study and within 3 months of Visit 1), or lung transplantation.

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

Здоровые добровольцы: Нет