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Study on the Effects of Budesonide, Glycopyrronium, and Formoterol in Patients Aged 40-80 with Chronic Obstructive Pulmonary Disease (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 treatment for Chronic Obstructive Pulmonary Disease (COPD), a condition that makes it hard to breathe. The treatment being tested is called Trixeo Aerosphere, which is a combination of three active substances: Budesonide, Glycopyrronium Bromide, and Formoterol Fumarate Dihydrate. These substances are delivered through a special inhaler. The study will compare two versions of this inhaler: one using a traditional propellant called HFA (hydrofluoroalkane) and another using a new propellant called HFO (hydrofluoroolefin). A placebo inhaler, which does not contain active medication, will also be used for comparison.

The purpose of the study is to see if the new HFO version of the inhaler works as well as the traditional HFA version in improving lung function in people with COPD. Participants in the study will use each type of inhaler for a period of time, and their lung function will be measured to assess the effectiveness of the treatments. The study will last for about four weeks, and participants will switch between the different inhalers during this time.

Throughout the study, participants will be monitored for any changes in their health, including vital signs like blood pressure and heart rate. The study aims to ensure that the new HFO inhaler is just as safe and effective as the current HFA inhaler for people with COPD. This research is important for potentially improving treatment options for those living with this chronic lung condition.

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
Joining the study
Upon joining the study, participants are required to meet specific criteria, including age between 40 and 80 years, a history of smoking, and a diagnosis of moderate to severe chronic obstructive pulmonary disease (COPD).
Participants must demonstrate the ability to use the inhaler correctly and comply with the study requirements.
Step 2
Initial assessment
An initial assessment is conducted to evaluate lung function and ensure eligibility. This includes measuring the forced expiratory volume (FEV1) and the ratio of FEV1 to forced vital capacity (FVC).
Participants must have a pre-bronchodilator FEV1 of less than 80% of the predicted normal value.
Step 3
Treatment phase 1
Participants begin the first treatment phase, using the Trixeo Aerosphere inhaler, which contains budesonide, glycopyrronium bromide, and formoterol fumarate dihydrate. The dosage is 5 micrograms/7.2 micrograms/160 micrograms per inhalation.
The medication is administered via inhalation, and participants are required to use it as directed for a specified period.
Step 4
Crossover to placebo
After completing the first treatment phase, participants switch to a placebo inhaler that matches the appearance of the active treatment inhaler.
This phase is designed to assess the effectiveness of the active treatment compared to no active medication.
Step 5
Treatment phase 2
Participants then proceed to the second treatment phase, using the Trixeo Aerosphere inhaler formulated with a new propellant (HFO).
The dosage and administration method remain the same as in the first treatment phase.
Step 6
Final assessment
At the end of the study, a final assessment is conducted to evaluate changes in lung function and overall health.
The primary goal is to compare the effectiveness of the two formulations of the inhaler on lung function.

Who can join the trial?

15 criteria

Participants must be between 40 and 80 years old when signing the consent form.
Participants should have a documented history of **COPD** (Chronic Obstructive Pulmonary Disease) diagnosed by a doctor.
Participants must have been using certain inhaled therapies for COPD for at least 4 weeks before the first visit, or they should not have used any COPD treatment in the 4 weeks before the first visit.
At the first visit, participants should have a blood **eosinophil** count of less than 300 cells per microliter. Eosinophils are a type of white blood cell.
At the first visit, participants should have a **pre-bronchodilator FEV1** of less than 80% of the predicted normal. FEV1 is a measure of how much air you can forcefully exhale in one second.
At the second visit, participants should have a **post-bronchodilator FEV1/FVC ratio** of less than 0.70 and a post-bronchodilator FEV1 between 40% and less than 80% of the predicted normal. FVC is the total amount of air you can exhale after taking a deep breath.
At the third visit, participants should have a **pre-dose FEV1** of less than 80% of the predicted normal, which is within 20% or 200 mL of their second visit pre-bronchodilator FEV1, and an FEV1/FVC ratio of less than 0.70.
Participants should be current or former smokers with a history of at least 10 pack-years of smoking. A pack-year is smoking 20 cigarettes a day for one year.
Participants must be willing and able, according to the study doctor, to adjust their current COPD therapy as required by the study.
Participants must be willing to stay at the study center as needed to complete all visit assessments.
Female participants must not be able to have children or must use a highly effective form of birth control.
Participants must be able to give signed informed consent, which means they understand and agree to the study's requirements and restrictions.
Participants should have a calculated **eGFR** greater than 30 mL/min/1.73 m² using the CKD-EPI formula. eGFR is a measure of kidney function.
Participants must demonstrate acceptable techniques for using the **MDI** (Metered Dose Inhaler) and performing **spirometry**. Spirometry is a test to measure lung function.
Participants must remain compliant with placebo run-in administrations, taking at least 80% of planned doses over the last 7 days before the third visit, based on electronic diary data.

Who cannot join the trial?

8 criteria

Patients with other serious lung diseases besides Chronic Obstructive Pulmonary Disease (COPD) cannot participate. COPD is a long-term lung disease that makes it hard to breathe.
Patients who have had a recent lung infection or illness that affects their breathing are not eligible.
Patients who have been hospitalized for breathing problems in the last few months cannot join the study.
Patients who are currently using certain medications that might interfere with the study treatment are excluded.
Patients with a history of severe allergies or reactions to medications used in the study cannot participate.
Patients with other serious health conditions that might affect their safety or the study results are not eligible.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who are unable to follow the study procedures or attend study visits are excluded.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Diagnostic Consultative Centre Ascendent OOD
Sofia, Bulgaria
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Wojewodzki Szpital Spec im. sw. Rafala w Czerwonej Gorze Swietokrzyskie Centrum Chorob Pluc
Checiny, Poland

Trial locations

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Investigated drugs

Budesonide
is a medication used to help reduce inflammation in the lungs. It is often used in the treatment of chronic obstructive pulmonary disease (COPD) to help improve breathing and reduce symptoms.
Glycopyrronium
is a medication that helps to relax and open the airways in the lungs, making it easier to breathe. It is used in the management of COPD to help control symptoms and improve lung function.
Formoterol Fumarate
is a medication that works by relaxing muscles in the airways to improve breathing. It is used in the treatment of COPD to help prevent and control symptoms such as wheezing and shortness of breath.

What is already known about the treatment

Budesonide
Budesonide is administered via inhalation using a metered-dose inhaler (MDI). It is currently used in the treatment of respiratory conditions and is well-documented in medical literature. The main therapeutic indication for Budesonide is to manage symptoms of moderate to severe chronic obstructive pulmonary disease (COPD). At the molecular level, Budesonide works by reducing inflammation in the airways, helping to improve breathing. It is classified as a corticosteroid.
Glycopyrronium
Glycopyrronium is delivered through inhalation using a metered-dose inhaler (MDI). It is recognized in medical literature for its role in treating respiratory disorders. The primary therapeutic use of Glycopyrronium is to alleviate symptoms of moderate to severe chronic obstructive pulmonary disease (COPD). Its mechanism of action involves blocking certain receptors in the airways, leading to relaxation of the muscles and improved airflow. Glycopyrronium is classified as a long-acting muscarinic antagonist (LAMA).
Formoterol Fumarate
Formoterol Fumarate is administered by inhalation using a metered-dose inhaler (MDI). It is widely used and documented in medical literature for respiratory conditions. The main therapeutic indication for Formoterol Fumarate is to treat moderate to severe chronic obstructive pulmonary disease (COPD). It works by stimulating beta-2 receptors in the lungs, leading to muscle relaxation and improved breathing. Formoterol Fumarate is classified 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, which can lead to breathing difficulties. The disease progresses slowly and can cause symptoms such as coughing, wheezing, and shortness of breath. Over time, the airways and air sacs in the lungs lose their elasticity, and the walls between many of the air sacs are destroyed. The walls of the airways become thick and inflamed, and the airways produce more mucus than usual, which can clog them. This condition is often caused by long-term exposure to irritating gases or particulate matter, most often from cigarette smoke.