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Can a COPD inhaler also help your heart?

NCT ID NCT07073950

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 6 times

Summary

This study tests a triple-combination inhaler (budesonide, glycopyrronium, and formoterol) against a placebo in 56 people with COPD and lung hyperinflation. The goal is to see if the inhaler improves both lung function and heart function, measured by MRI. Participants will receive the inhaler or placebo in a crossover design, meaning everyone gets both treatments at different times.

What this could mean

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

Active substance
Budesonide/Glycopyrronium/Formoterol fumarate (a triple-combination inhaler)
What this could lead to
If it works, this could show that the inhaler improves both lung and heart function in people with COPD and hyperinflation, potentially leading to better management of the disease.
What could go wrong
This is a small, early-phase 4 trial with only 56 participants, so results may not apply to everyone. The study is also short-term, so long-term benefits or risks are unknown.

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

About 56 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

40 to 80 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.

Key Inclusion Criteria: * 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) \< 0.7. * 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) ≥ 1. * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    RECRUITING

    Ahrensburg, 22926, Germany

  • Research Site

    RECRUITING

    Berlin, 14050, Germany

  • Research Site

    RECRUITING

    Frankfurt, 60596, Germany

  • Research Site

    RECRUITING

    Hanover, 30625, Germany

  • Research Site

    WITHDRAWN

    Harefield, UB9 6JH, United Kingdom

  • Research Site

    RECRUITING

    London, W1T 6AH, United Kingdom

  • Research Site

    RECRUITING

    Manchester, M23 9QZ, United Kingdom

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