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Study on the Effects of Umeclidinium and Vilanterol in Patients with COPD and Heart Failure

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for patients with Chronic Obstructive Pulmonary Disease (COPD) and heart failure. The treatment being tested is a combination of two medications, umeclidinium bromide and vilanterol, which are delivered as an inhalation powder called Anoro Ellipta. The study will compare the effects of this treatment to a placebo. Additionally, the study involves other medications such as Ventolin, which contains salbutamol sulfate, and Flixotide, which contains fluticasone propionate.

The purpose of the study is to investigate how the treatment with umeclidinium bromide and vilanterol affects the heart's ability to pump blood during exercise in patients with COPD. Participants will receive the treatment or a placebo and will undergo various tests to measure their heart and lung function. These tests include exercise tests and imaging techniques like MRI and echocardiography, which use sound waves to create images of the heart.

The study will take place over a period of time, during which participants will be monitored for changes in their heart and lung function. The goal is to understand if the treatment can improve the heart's performance during physical activity and provide better management of symptoms for patients with COPD and heart failure. Participants will be closely observed to ensure their safety and to gather accurate data on the treatment's effects.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, smoking history, and lung function.

    The study focuses on individuals with chronic obstructive pulmonary disease (COPD) and heart failure.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline measurements. This includes lung function tests and heart evaluations using echocardiography and MRI.

    These tests help in understanding the current health status and setting a reference point for future comparisons.

  3. Step 3

    Medication administration

    Participants receive either ANORO ELLIPTA (umeclidinium bromide and vilanterol) or a placebo. The medication is administered as an inhalation powder.

    The dosage is 55 micrograms of umeclidinium and 22 micrograms of vilanterol, taken once daily.

  4. Step 4

    Exercise testing

    Participants undergo exercise testing to measure the effect of the medication on heart and lung function during physical activity.

    This includes a cardiopulmonary exercise test on a cycle-ergometer and Doppler-echocardiography to assess stroke volume and oxygen pulse.

  5. Step 5

    Ongoing monitoring

    Throughout the study, regular monitoring of lung volumes and heart function is conducted.

    Measurements include inspiratory capacity, functional residual capacity, and cardiac chamber volumes at rest.

  6. Step 6

    Final assessment

    At the end of the study period, a final assessment is performed to evaluate changes in health status.

    This includes repeating the initial tests to compare with baseline measurements and determine the effect of the treatment.

Who can join the trial?

7 criteria

  • Patients must be at least 40 years old and have a clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD), which is a long-term lung condition that makes it hard to breathe.
  • Patients should have airflow limitation, shown by a test where the amount of air they can blow out in one second (called FEV1) is less than 80% of what is expected for their age and size. Also, the ratio of FEV1 to the total amount of air they can blow out (called FVC) should be less than 0.7.
  • Patients need to have a smoking history of at least ten pack-years. This means they have smoked the equivalent of one pack of cigarettes per day for ten years.
  • Patients should have lung hyperinflation, which means their lungs have more air than normal. This is shown by a test where the amount of air left in the lungs after breathing out (called residual volume) is more than 135% of what is expected.
  • Patients must have stable heart failure, meaning their heart condition is not getting worse.
  • Patients should have a left ventricle ejection fraction between 35% and 55%. This is a measure of how well the heart pumps blood with each beat.
  • Patients need to have a suitable ultrasonic window from the apical view, which means the doctor can get a clear ultrasound image of the heart from a specific angle.

Who cannot join the trial?

10 criteria

  • Patients with a history of severe allergic reactions to the study medication.
  • Patients who have had a heart attack or stroke in the past 6 months.
  • Patients with uncontrolled high blood pressure.
  • Patients with other serious heart conditions that are not stable.
  • Patients who are pregnant or breastfeeding.
  • Patients who are currently participating in another clinical trial.
  • Patients with severe liver or kidney disease.
  • Patients with a history of drug or alcohol abuse in the past year.
  • Patients who cannot perform the required physical activities for the study.
  • Patients with any other medical condition that the study doctors believe would make it unsafe to participate.
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Investigated drugs

Umeclidinium/Vilanterol is a combination medication used in this clinical trial to help patients with COPD, which stands for chronic obstructive pulmonary disease. This medication works by relaxing and opening the airways in the lungs, making it easier for patients to breathe. It is being studied to see how it affects the heart's ability to pump more blood during exercise in patients who also have heart failure.

What is already known about the treatment

Umeclidinium/Vilanterol – This medication is administered as an inhalation powder, typically using an inhaler device. It is currently being studied in clinical trials for its effects on patients with chronic obstructive pulmonary disease (COPD) and heart failure with a specific range of ventricular ejection fraction. The main therapeutic indication is to improve lung function and exercise capacity in these patients. At the molecular level, umeclidinium acts as a long-acting muscarinic antagonist, while vilanterol is a long-acting beta-agonist; together, they help relax and open the airways in the lungs. This combination is classified as a bronchodilator.

Investigated diseases

  • Chronic Obstructive Pulmonary Disease (COPD)

    This is a long-term lung condition that makes it hard to breathe due to airflow blockage. It typically involves symptoms like chronic cough, mucus production, and shortness of breath. Over time, the disease can lead to decreased lung function and increased difficulty in performing physical activities. COPD is often caused by long-term exposure to irritating gases or particulate matter, most commonly from cigarette smoke. The disease progresses gradually, with symptoms worsening over time. It can also lead to complications such as frequent respiratory infections and heart problems.

  • Heart Failure with Mid-Range Ejection Fraction

    This condition occurs when the heart's left ventricle does not pump blood as efficiently as it should, with an ejection fraction between 35-50%. It can result in symptoms like fatigue, shortness of breath, and fluid retention. The heart's reduced pumping ability can lead to a buildup of fluid in the lungs and other parts of the body. This type of heart failure is often associated with underlying conditions such as high blood pressure or coronary artery disease. Over time, the heart may become weaker, and symptoms can become more severe. The condition requires careful management to prevent further deterioration of heart function.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519513-61-00Protocol codeCHHEFEstimated enrolment60 patientsSponsorHospital General Universitario Gregorio Maranon

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