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Study on the Effects of Budesonide, Glycopyrronium, and Formoterol Fumarate for Patients with Chronic Obstructive Pulmonary Disease (COPD)

Fast replyRegistered drugNo placebo
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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 Chronic Obstructive Pulmonary Disease (COPD), a long-term lung condition that makes it hard to breathe. The study will evaluate the effectiveness of a new treatment using a combination of medications delivered through an inhaler. The medications being tested include Budesonide, Glycopyrronium Bromide, and Formoterol Fumarate Dihydrate, which are combined in a product called Trixeo Aerosphere. This combination is compared to another inhaler treatment called Bevespi Aerosphere, which contains Glycopyrronium Bromide and Formoterol Fumarate Dihydrate. Additionally, the study involves the use of Salbutamol, a common medication for relieving breathing difficulties.

The purpose of the study is to assess how well these treatments work in improving heart and lung health in people with COPD. Participants will be randomly assigned to receive one of the treatments or a placebo. The study will last for up to 36 months, during which participants will use the inhalers as directed and attend regular check-ups to monitor their health. The study aims to determine the time it takes for participants to experience severe heart or lung-related events, such as worsening of COPD symptoms or heart problems.

Throughout the study, participants will be closely monitored to ensure their safety and to gather information on how the treatments affect their condition. The results of this study will help to understand the benefits and risks of using these inhaler medications for managing COPD and improving overall heart and lung health.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, participants are required to demonstrate the correct technique for using a metered-dose inhaler (MDI) during the initial visits.

    Participants must be between 40 to 80 years old and have a confirmed diagnosis of chronic obstructive pulmonary disease (COPD).

  2. Step 2

    Initial assessment

    An initial assessment includes a blood test to measure eosinophil count and a COPD assessment test (CAT) score.

    Participants must have a history of smoking and meet specific cardiovascular risk criteria.

  3. Step 3

    Randomization

    Participants are randomly assigned to receive either the combination triple therapy or the dual bronchodilator therapy.

    The combination therapy includes budesonide, glycopyrronium, and formoterol fumarate, while the dual therapy includes glycopyrronium and formoterol fumarate.

  4. Step 4

    Treatment administration

    Participants use the assigned inhalation therapy daily as per the study protocol.

    The combination therapy is administered as Trixeo Aerosphere, and the dual therapy as Bevespi Aerosphere, both via inhalation.

  5. Step 5

    Ongoing monitoring

    Participants attend regular visits, either in-person or virtually, to monitor their health and the effects of the treatment.

    The study aims to evaluate the time to the first severe cardiac or COPD event, among other health outcomes.

  6. Step 6

    Completion of study

    The study is expected to conclude by March 2028, with participants continuing their assigned treatment until the end of the study period.

    Final assessments will be conducted to evaluate the overall impact of the treatment on cardiopulmonary outcomes.

Who can join the trial?

14 criteria

  • Participants must be between 40 and 80 years old.
  • Participants must be willing to visit the study site or join virtual visits as needed to complete all study assessments.
  • Participants must show they can use an MDI (Metered Dose Inhaler) correctly at the first two visits.
  • Females can join if they are either unable to have children (permanently sterilized or post-menopausal) or if they can have children, they must have a negative pregnancy test and use a highly effective birth control method.
  • Participants must be able to give signed informed consent, agreeing to follow the study's requirements and restrictions.
  • Participants must have a confirmed diagnosis of **COPD** (Chronic Obstructive Pulmonary Disease) with specific lung function test results.
  • Participants must be current or former smokers with a history of smoking at least 10 pack-years. This means the number of cigarettes smoked per day divided by 20, multiplied by the number of years smoked. Former smokers must have quit at least 6 months before the first visit.
  • Participants must have a certain level of eosinophils (a type of white blood cell) in their blood, measured at the first visit.
  • Participants must have a **CAT** (COPD Assessment Test) score of 10 or higher at the first visit.
  • Participants must meet at least one of the following cardiovascular (heart and blood vessel) disease or risk factor criteria:
    • Have established cardiovascular disease.
    • Have a combination of cardiovascular risk factors such as high blood pressure, diabetes, chronic kidney disease, abnormal cholesterol levels, or obesity.
    • Be at high risk of cardiovascular disease based on a risk assessment tool.
    • Have coronary artery calcification seen on a CT scan.
    • Participants must be willing and able, according to the investigator, to adjust their current COPD treatment as required by the study protocol.

Who cannot join the trial?

8 criteria

  • Patients with a history of severe heart or lung problems that are not related to **Chronic Obstructive Pulmonary Disease (COPD)**.
  • Patients who have had a recent heart attack or stroke.
  • Patients with uncontrolled high blood pressure.
  • Patients with a history of severe allergic reactions to medications.
  • Patients who are currently participating in another clinical trial.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of drug or alcohol abuse.
  • Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate.
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Investigated drugs

  • Budesonide

    is a medication used in this trial as part of a combination therapy. It is a type of steroid that helps reduce inflammation in the lungs, making it easier to breathe for people with chronic obstructive pulmonary disease (COPD).

  • Glycopyrronium

    is included in both the combination and dual therapies in this trial. It is a bronchodilator, which means it helps open up the airways in the lungs, making breathing easier for patients with COPD.

  • Formoterol Fumarate

    is another medication used in both the combination and dual therapies. It is a long-acting bronchodilator that helps relax muscles in the airways to improve breathing in people with COPD.

What is already known about the treatment

  • Budesonide

    Budesonide is administered via a metered-dose inhaler and is currently being studied in clinical trials for its effectiveness in treating Chronic Obstructive Pulmonary Disease (COPD). It is a well-established medication in medical literature, primarily used for its anti-inflammatory properties. Budesonide works by reducing inflammation in the airways, helping to improve breathing in patients with COPD. It belongs to the pharmacological class of corticosteroids.

  • Glycopyrronium

    Glycopyrronium is delivered through a metered-dose inhaler and is part of ongoing clinical trials for COPD treatment. It is recognized in medical literature as a bronchodilator, which helps to relax and open the air passages in the lungs. Glycopyrronium acts by blocking certain receptors in the lungs, leading to muscle relaxation and improved airflow. It is classified as a long-acting muscarinic antagonist (LAMA).

  • Formoterol Fumarate

    Formoterol Fumarate is used via a metered-dose inhaler and is being evaluated in clinical trials for its role in managing COPD. It is well-documented in medical literature as a bronchodilator that helps to ease breathing by relaxing muscles in the airways. Formoterol Fumarate works by stimulating beta-2 adrenergic receptors, leading to muscle relaxation and enhanced airflow. It is categorized as a long-acting beta-agonist (LABA).

Investigated diseases

Chronic Obstructive Pulmonary Disease (COPD) – This is a long-term lung disease that makes it hard to breathe. It is characterized by a persistent blockage of airflow from the lungs, leading to breathing difficulties. The disease progresses slowly and is often caused by long-term exposure to irritating gases or particulate matter, most commonly from cigarette smoke. Over time, symptoms such as chronic cough, mucus production, and wheezing may worsen. As the disease advances, individuals may experience increased breathlessness and fatigue. COPD can lead to frequent respiratory infections and may significantly impact daily activities.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507407-59-00Protocol codeD5989C00001 THARROSEstimated enrolment5 000 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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