Phase IV, Single-center, Double Blind, Randomized, Crossover, Placebo-controlled Study, to Investigate the Effect of Dual Bronchodilation With Umeclidinium Vilanterol on Patients With COPD, Hyperinflation and Heart Failure.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline on the increase in exercise oxygen pulse.
研究概览
简要总结
Double-blind, randomized, two-period crossover, placebo-controlled, single-center study, to determine the effect of umeclidinium/vilanterol 55/22 μg compared with placebo on the increase in left systolic chamber function during exercise in patients with COPD, lung hyperinflation and mild to moderate left ventricular dysfunction.
详细描述
Phase IV clinical trial, single-center, double-blind, randomized, two-period crossover, placebo-controlled, to determine the effect of treatment with umeclidinium/vilanterol 55/22 μg compared with placebo on the increase in left systolic chamber function during exercise in patients with COPD, lung hyperinflation and mild to moderate left ventricular dysfunction.
The participants will be patients from the outpatient offices of the Cardiology, Pulmonology and Internal Medicine departments of the Gregorio Marañon University Hospital in Madrid, over 40 years of age with a diagnosis of COPD, lung hyperinflation with a residual volume more than 135 % and stable heart failure with a left ventricular ejection fraction between 35-55%.
Patients will be randomly assigned (1:1) to either umeclidinium/vilanterol 55/22 μg Ellipta for 14 days followed by a washout period of 14 days and then placebo for 14 days, or the same treatments in reverse order.
The randomization numbers will be generated by blocks of 4 elements selected with a computer-generated random list.
Patients, investigators, individuals in charge of the assessments, sponsor, CRO staff, and data analysts will be blinded to the identity and assignment of the treatments from the time of randomization until database lock, using the following methods:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and 85 years with a clinical diagnosis of COPD
- •Airflow limitation indicated by a screening post-bronchodilator FEV1 < 80% and >35% predicted and a post-bronchodilator FEV1/FVC < 0.7
- •Smoking history of at least ten pack-years
- •Baseline lung hyperinflation with a residual volume of more than 135% predicted
- •Stable heart failure
- •Left ventricle ejection fraction in the range of 35% to 55%.
- •A suitable ultrasonic window from the apical view
- •No exacerbation within 2 months before study recruitment (defined as the use of systemic corticoids, antibiotics, or hospitalization)
排除标准
- •Do not sign the informed consent
- •Unstable cardiovascular diseases
- •Atrial fibrillation or other arrhythmias requiring treatment
- •Unstable ischemic heart disease
- •Uncontrolled hypertension
- •Patients unable to undergo cardiac MR scanning (claustrophobia or carrying non-MR-compatible devices)
- •Patients unable to perform an exercise test (locomotor conditions)
研究组 & 干预措施
Umeclidinium/vilanterol
Umeclidinium/vilanterol 55/22 μg inhaled once a day for 14 days.
干预措施: Umeclidinium/vilanterol (Drug)
Placebo
Placebo inhaled once a day for 14 days.
干预措施: Placebo (Other)
结局指标
主要结局
Change from baseline on the increase in exercise oxygen pulse.
时间窗: 0, 14, 42 days (Visits 4, 5 and 7 respectively)
Maximal oxygen pulse on a cardiopulmonary exercise test on Cycle-ergometer
Change from baseline on the increase in exercise stroke volume.
时间窗: 0, 14, 42 days (Visits 4, 5 and 7 respectively)
Baseline-corrected, time-velocity integral (a direct surrogate of SV) during peak exercise, as measured by exercise Doppler-echocardiography.
次要结局
- Change from baseline on the reduction of resting hyperinflation..(Screening (-14), 0, 14, 42 days (Visits 4, 5 and 7 respectively))
- Change from baseline on resting systolic left cardiac function.(0, 14, 42 days (Visits 4, 5 and 7 respectively))
- Change from baseline on the reduction of dynamic hyperinflation.(Screening (-14), 0, 14, 42 days (Visits 4, 5 and 7 respectively))
- Change from baseline on resting right cardiac function.(0, 14, 42 days (Visits 4, 5 and 7 respectively))
- Change from baseline on resting dyastolic left heart function.(0, 14, 42 days (Visits 4, 5 and 7 respectively))
- Change from baseline on resting left cardiac function.(0, 14, 42 days (Visits 4, 5 and 7 respectively))
- Change from baseline on PROMs (Impact of disease).(0, 14, 42 days (Visits 4, 5 and 7 respectively))
- Change from baseline on PROMs (dyspnea).(0, 14, 42 days (Visits 4, 5 and 7 respectively))
研究者
Luis Puente Maestu
Professor
Hospital General Universitario Gregorio Marañon