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Study on the Effects of Inhaled Budesonide, Glycopyrronium Bromide, and Formoterol Fumarate Dihydrate in Patients with Stable COPD

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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 medication called Trixeo Aerosphere on patients with Chronic Obstructive Pulmonary Disease (COPD). COPD is a long-term lung disease that makes it hard to breathe. The medication being tested is a combination of three active substances: budesonide, glycopyrronium bromide, and formoterol fumarate dihydrate. These substances are delivered through a pressurized inhaler, which helps patients breathe in the medication directly into their lungs.

The purpose of the study is to see how this medication affects the way patients breathe over a period of one month. Participants will use the inhaler as part of their daily routine. The study will observe changes in their breathing patterns, including how complex and variable their breathing is. This will help researchers understand if the medication can improve the breathing of people with stable COPD.

Throughout the study, participants will have their breathing measured at different times to see how it changes with the use of the medication. The study will also look at other aspects of lung function and symptoms, such as how often and how deeply patients breathe, and how they feel in terms of breathlessness. This information will help determine the effectiveness of the medication in managing COPD symptoms.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Sign an informed consent form to confirm understanding and agreement to participate in the study.

    Ensure eligibility by meeting criteria such as age between 40-75 years, a history of chronic obstructive pulmonary disease (COPD), and a smoking history of more than 10 pack-years.

  2. Step 2

    Initial assessment

    Undergo a baseline assessment to measure lung function and breathing patterns. This includes spirometry to assess lung capacity and function.

    Complete questionnaires to evaluate symptoms such as dyspnea (difficulty breathing) and overall health status.

  3. Step 3

    Treatment phase

    Begin treatment with Trixeo Aerosphere, which contains budesonide, glycopyrronium bromide, and formoterol fumarate dihydrate.

    Administer the medication via inhalation as a pressurised suspension. The dosage is 5 micrograms of glycopyrronium bromide, 7.2 micrograms of formoterol fumarate dihydrate, and 160 micrograms of budesonide per inhalation.

    Continue the treatment for a duration of one month, following the prescribed frequency and dosage.

  4. Step 4

    Follow-up assessment

    Attend a follow-up visit to evaluate changes in lung function and breathing patterns after one month of treatment.

    Measurements will include changes in ventilation pattern complexity and variability, as well as other lung function parameters such as respiratory frequency and volume.

  5. Step 5

    Final evaluation

    Complete final assessments to determine the overall impact of the treatment on symptoms and lung function.

    This includes a comparison of pre-treatment and post-treatment measurements to assess improvements or changes in breathing and lung function.

Who can join the trial?

5 criteria

  • Provide a signed informed consent before any study-specific procedure. This means you agree to participate after understanding the study details.
  • Be a female or male aged between 40 and 75 years at the time of joining the study.
  • Have a documented history of **COPD**. This is a lung condition that makes it hard to breathe. Your lung function test should show a specific pattern: a post-bronchodilator **FEV1/FVC** ratio of less than 0.70 and a post-bronchodilator **FEV1** between 30% and 70% of the predicted normal value. **FEV1** is the amount of air you can forcefully exhale in one second, and **FVC** is the total amount of air you can exhale after taking a deep breath.
  • Have a smoking history of more than 10 pack-years. A pack-year is a way to measure how much someone has smoked over time. For example, smoking one pack a day for 10 years equals 10 pack-years.
  • Experience significant **dyspnea** at baseline, which means you have noticeable difficulty breathing. This is measured by a score of 2 or more on the **mMRC** scale, a tool used to assess breathlessness.

Who cannot join the trial?

5 criteria

  • Patients who are not diagnosed with **COPD**. COPD stands for **Chronic Obstructive Pulmonary Disease**, which is a long-term lung condition that makes it hard to breathe.
  • Patients who are not considered stable in their COPD condition. This means their symptoms are not well-controlled or they have frequent flare-ups.
  • Patients who are not within the specified age range for the study. The study may have specific age requirements that participants must meet.
  • Patients who are part of a vulnerable population. This refers to groups of people who may need special protection or care, such as children or the elderly.
  • Patients who are not able to follow the study procedures or instructions. This could be due to various reasons, such as language barriers or cognitive difficulties.
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Investigated drugs

BGF 160 is an inhaled medication being studied for its effects on breathing patterns in patients with stable Chronic Obstructive Pulmonary Disease (COPD). The trial aims to see how this medication changes the complexity and variability of breathing after one month of use. BGF 160 is designed to help improve lung function and make breathing easier for people with COPD.

What is already known about the treatment

BGF 160 – This medication is administered through inhalation and is currently being studied in clinical trials for its effects on patients with stable Chronic Obstructive Pulmonary Disease (COPD). The main therapeutic indication is to assess its impact on the complexity and variability of breathing patterns in these patients. BGF 160 works by targeting specific receptors in the lungs to improve airflow and reduce symptoms associated with COPD. It is classified pharmacologically as a combination inhaler, typically containing a mix of bronchodilators and anti-inflammatory agents.

Investigated diseases

Chronic Obstructive Pulmonary Disease (COPD) – COPD is a long-term lung disease that causes breathing difficulties due to airflow blockage. It typically involves two main conditions: emphysema, which damages the air sacs in the lungs, and chronic bronchitis, which causes inflammation and narrowing of the airways. Over time, COPD leads to increased breathlessness, frequent coughing, and wheezing. The disease progresses gradually, with symptoms worsening over the years. Patients may experience episodes of exacerbation, where symptoms become more severe. COPD is often linked to long-term exposure to irritating gases or particulate matter, most commonly from cigarette smoke.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514097-52-00Protocol code2022/0422Estimated enrolment35 patientsSponsorCentre Hospitalier Universitaire De Lille

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).