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Can an inhaler boost heart pumping in COPD patients?

NCT ID NCT04522596

NEW Symptom relief Sponsor: Luis Puente Maestu Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are testing whether an inhaled dual bronchodilator (umeclidinium/vilanterol) can improve heart function during exercise in people who have COPD, lung hyperinflation, and mild heart failure. About 60 adults aged 40 to 85 with these conditions will take either the drug or a placebo for a period, then switch to the other. The study measures changes in heart pumping and oxygen use during exercise, along with lung volumes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an inhaled combination bronchodilator containing umeclidinium and vilanterol
What this could lead to
If it works, this could offer a way to help people with COPD and mild heart failure breathe easier and exercise longer by improving how the heart pumps during activity.
What could go wrong
This is a small, single-center study, so results may not apply broadly. Inhaled bronchodilators can cause side effects like fast heartbeat or tremor, and the crossover design means each participant receives both the drug and placebo, which may limit how well the findings translate to long-term use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

60 people

The number who actually took part.

Started

May 2021

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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) Exclusion Criteria: * 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)

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease COPD, severe early onset heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COPD Heart failure

Contacts and locations

Locations

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007, Spain

More trials for these conditions

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