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Study of budesonide, glycopyrronium and formoterol inhaler to evaluate heart and lung function in patients with chronic obstructive pulmonary disease and hyperinflation

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What is this trial about?

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

This study focuses on people with Chronic Obstructive Pulmonary Disease who have increased lung volume. The research will test a combination inhaler called Trixeo Aerosphere, which contains three medicines: budesonide, glycopyrronium bromide, and formoterol fumarate dihydrate. These medications work together to help open the airways and reduce inflammation in the lungs.

The purpose of this research is to understand how this inhaled medication affects heart and lung function compared to placebo. The study will use special imaging techniques including magnetic resonance imaging to look at the heart's size and function. It will also measure how much air remains in the lungs after breathing out using a technique called body plethysmography.

During the study, participants will receive both the medication and placebo at different times through an inhaler device called a metered dose inhaler. The treatment will be given twice daily. Neither the participants nor the doctors will know which treatment is being given at any particular time. This helps ensure that the results are not influenced by expectations about the treatment.

The research process

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

Step 1
Initial assessment
Your lung function will be tested using spirometry to confirm COPD diagnosis and measure breathing capacity
A blood test will check your eosinophil count (type of white blood cells)
If you are a woman of childbearing age, a pregnancy test will be performed
Step 2
Baseline measurements
Your lung volume will be measured using a technique called body plethysmography
A magnetic resonance imaging (MRI) scan of your heart will be performed to measure heart chamber volume
Your breathing capacity will be tested before and after using an inhaler
Step 3
Treatment period 1
You will receive either Trixeo Aerosphere inhaler or a placebo inhaler
The inhaler contains three medicines: budesonide, glycopyrronium bromide, and formoterol fumarate
You will use the inhaler as directed by the study instructions
Neither you nor your doctor will know which inhaler you are receiving
Step 4
Measurements after first treatment
Your heart and lung function will be measured again using the same tests as before
These results will be compared to your initial measurements
Step 5
Treatment period 2
You will switch to the other inhaler (either Trixeo Aerosphere or placebo)
You will continue using the new inhaler as directed
Step 6
Final measurements
Final heart and lung function measurements will be taken
Results will be compared with previous measurements to assess treatment effects

Who can join the trial?

10 criteria

Must be a current or former smoker with at least 10 pack-years of smoking history (pack-years = number of packs smoked per day multiplied by years of smoking)
Women who can become pregnant must have a negative pregnancy test at the first visit
Must have confirmed COPD (Chronic Obstructive Pulmonary Disease) with specific breathing test results showing FEV1/FVC ratio less than 0.7 (these are measurements of how much air you can exhale)
Must have reduced lung function with FEV1 less than 80% of normal value before using bronchodilator medication (medication that helps open airways)
Must have a blood count showing less than 300 eosinophils (type of white blood cells) per cubic millimeter, with no history of higher counts in the past year
Must have at least grade 1 breathlessness on the Modified Medical Research Council (mMRC) scale (a measure of breathing difficulty)
Must have increased lung volume (FRC more than 135% of normal) at second visit
After using bronchodilator medication, lung function must be between 30% and 80% of normal value at second visit
Must be currently using one, two, or three inhaled medications for COPD maintenance
Female participants must either be unable to have children or using reliable birth control

Who cannot join the trial?

15 criteria

Patients younger than 18 years of age
Current or active lung diseases other than COPD (Chronic Obstructive Pulmonary Disease)
History of asthma
Current respiratory tract infection (infection affecting breathing passages)
Significant heart problems or unstable heart conditions
Allergies or hypersensitivity to study medications
Participation in other clinical trials within the past 30 days
History of alcohol or drug abuse within the past 12 months
Pregnant women or women planning pregnancy
Breastfeeding women
Serious medical conditions that could interfere with study participation
Unable to perform required breathing tests
Current smokers who are unwilling to quit during the study period
Major surgery within the past 3 months
Inability to comply with study procedures

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Verified sites

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PAREXEL International GmbH
Berlin, Germany
Verified
Velocity Clinical Research Luebeck GmbH
Luebeck, Germany

Trial locations

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Investigated drugs

Budesonide/Glycopyrronium/Formoterol Fumarate is a combination inhaler medication that contains three active ingredients working together to help people with chronic obstructive pulmonary disease (COPD). Budesonide is a corticosteroid that reduces inflammation in the airways. Glycopyrronium is a long-acting muscarinic antagonist that helps relax and open the airways. Formoterol fumarate is a long-acting beta-2 agonist that also helps open the airways and makes breathing easier. The medication is delivered through a metered dose inhaler, which helps patients inhale the precise amount of medicine they need.

What is already known about the treatment

Budesonide
A corticosteroid medication administered through a metered-dose inhaler for treating Chronic Obstructive Pulmonary Disease (COPD). It works by reducing inflammation in the airways, helping to ease breathing difficulties and prevent exacerbations. This anti-inflammatory drug belongs to the class of inhaled corticosteroids and acts locally in the lungs by suppressing inflammatory cell activation and inflammatory mediator release.
Glycopyrronium
An inhaled long-acting anticholinergic bronchodilator used in the treatment of COPD. It works by blocking acetylcholine receptors in the airways, which helps to relax and widen the breathing passages. This medication belongs to the class of antimuscarinic agents and provides sustained bronchodilation for easier breathing in COPD patients.
Formoterol Fumarate
A long-acting beta-2 agonist bronchodilator delivered via inhaler for COPD treatment. It works by relaxing smooth muscle in the airways, providing long-lasting relief from breathing difficulties. This medication belongs to the class of beta-2 adrenergic agonists and helps maintain open airways for up to 12 hours, making breathing easier for patients with COPD.

Investigated diseases

Chronic Obstructive Pulmonary Disease - A progressive lung condition that makes breathing increasingly difficult over time. The disease causes the airways to become inflamed and narrowed, while also damaging the tiny air sacs (alveoli) in the lungs. This leads to persistent airflow limitation and makes it harder for air to move in and out of the lungs. The condition typically develops slowly and is characterized by symptoms such as shortness of breath, chronic cough, and increased mucus production. People with COPD often experience episodes where their symptoms become worse than usual, known as exacerbations.