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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 56
- 试验地点
- 7
- 主要终点
- Change from baseline in left ventricular end diastolic volume indexed by body surface area (LVEDVi) measured by magnetic resonance imaging (MRI)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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) ≥
- •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.
排除标准
- •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.
研究组 & 干预措施
Sequence 1: BGF MDI and Placebo
Participants will receive BGF MDI in Period 1 followed by Placebo in Period 2.
干预措施: Budesonide/Glycopyrronium/Formoterol Fumarate (Drug)
Sequence 1: BGF MDI and Placebo
Participants will receive BGF MDI in Period 1 followed by Placebo in Period 2.
干预措施: Placebo (Drug)
Sequence 2: Placebo and BGF MDI
Participants will receive Placebo in Period 1 followed by BGF MDI in Period 2.
干预措施: Budesonide/Glycopyrronium/Formoterol Fumarate (Drug)
Sequence 2: Placebo and BGF MDI
Participants will receive Placebo in Period 1 followed by BGF MDI in Period 2.
干预措施: Placebo (Drug)
Sequence 2: Placebo and BGF MDI
Participants will receive Placebo in Period 1 followed by BGF MDI in Period 2.
干预措施: Metered dose inhaler (Device)
Sequence 1: BGF MDI and Placebo
Participants will receive BGF MDI in Period 1 followed by Placebo in Period 2.
干预措施: Metered dose inhaler (Device)
结局指标
主要结局
Change from baseline in left ventricular end diastolic volume indexed by body surface area (LVEDVi) measured by magnetic resonance imaging (MRI)
时间窗: Up to 3 weeks
The effect of BGF relative to placebo on LVEDVi in participants with COPD and hyperinflation will be evaluated.
次要结局
- Change from baseline in functional residual capacity/total lung capacity (FRC/TLC) measured by body plethysmography(Up to 3 weeks)
- Change from baseline in residual volume/total lung capacity (RV/TLC) measured by body plethysmography(Up to 3 weeks)