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Effect of dual bronchodilation with umeclidinium/vilanterol on patients with COPD, hyperinflation and heart failure
EU CTIS ID: 2024-519513-61-00
What this study is testing
To address the effect of treatment with umeclidinium/vilanterol 55/22 μg compared to placebo on the increase in stroke volume during exercise in patients with COPD
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients aged at least 40 years with a clinical diagnosis of COPD
- Airflow limitation indicated by a screening post-bronchodilator FEV1 of less than 80% predicted and a post-bronchodilator FEV1 to forced vital capacity (FVC) ratio of less than 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%
You likely can't join if
- 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)
See the full eligibility criteria
- Patients aged at least 40 years with a clinical diagnosis of COPD
- Airflow limitation indicated by a screening post-bronchodilator FEV1 of less than 80% predicted and a post-bronchodilator FEV1 to forced vital capacity (FVC) ratio of less than 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
- 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 exercise test (locomotor conditions)
- Inadequate ultrasound window from the apical view
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.