Can a COPD inhaler also help your heart?
NCT ID NCT07073950
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 56 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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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
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40 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
6 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Research Site
RECRUITINGAhrensburg, 22926, Germany
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Research Site
RECRUITINGBerlin, 14050, Germany
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Research Site
RECRUITINGFrankfurt, 60596, Germany
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Research Site
RECRUITINGHanover, 30625, Germany
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Research Site
WITHDRAWNHarefield, UB9 6JH, United Kingdom
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Research Site
RECRUITINGLondon, W1T 6AH, United Kingdom
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Research Site
RECRUITINGManchester, M23 9QZ, United Kingdom
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