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

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What is this study about?

This clinical trial is focused on studying the effects of different inhalation treatments for people with Chronic Obstructive Pulmonary Disease (COPD). COPD is a long-term lung disease that makes it hard to breathe. The study will compare the effects of a combination of medications delivered through a metered dose inhaler (MDI). These medications include Budesonide, Glycopyrronium Bromide, and Formoterol Fumarate Dihydrate, referred to as BGF MDI. Another combination being studied is Budesonide and Formoterol Fumarate, known as BFF MDI. A placebo MDI, which looks like the real medication but does not contain active ingredients, will also be used for comparison.

The purpose of the study is to assess how these treatments affect breathing and exercise capacity in people with COPD. Participants will use each of the inhalers, including the placebo, during different periods of the study. The study is designed to be “double-blind,” meaning neither the participants nor the researchers will know which treatment is being used at any given time, to ensure unbiased results. The study will take place over several weeks, with participants visiting the study site for assessments and to receive their inhalers.

Throughout the study, participants will be monitored for changes in their breathing and exercise performance. The main focus will be on how well the lungs can expand during exercise, known as “dynamic hyperinflation.” This will help researchers understand the effectiveness of the BGF MDI compared to the BFF MDI and the placebo. Participants will also be observed for any side effects or adverse reactions to the treatments. The study aims to provide valuable information on how these inhalation treatments can help manage COPD symptoms and improve quality of life for those affected by the disease.

1 joining the study

Upon joining the study, participants will be randomly assigned to receive one of three treatments: a metered dose inhaler (MDI) containing budesonide, glycopyrronium, and formoterol fumarate (BGF), a metered dose inhaler containing budesonide and formoterol fumarate (BFF), or a placebo metered dose inhaler.

The study is designed to be double-blind, meaning neither the participants nor the researchers will know which treatment is being administered during each period.

2 treatment periods

The study consists of three treatment periods. Each period involves the use of one of the three inhalers: BGF MDI, BFF MDI, or placebo MDI.

Participants will use the assigned inhaler through inhalation as directed by the study protocol.

3 exercise testing

During each treatment period, participants will undergo exercise testing to evaluate the effect of the inhalers on exercise parameters.

The primary focus is on measuring the inspiratory capacity during exercise, which helps assess lung function.

4 monitoring and assessments

Throughout the study, participants will be monitored for any side effects or adverse events related to the treatments.

Regular assessments will include measuring lung volumes and exercise endurance time to gather comprehensive data on the effects of the treatments.

5 completion of study

After completing all treatment periods and assessments, participants will finish their involvement in the study.

The data collected will be used to evaluate the effectiveness of the treatments on exercise parameters in individuals with chronic obstructive pulmonary disease (COPD).

Who Can Join the Study?

  • Must be a male or female between 40 and 80 years old.
  • Must have a confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD) with specific lung function test results.
  • Must be currently using a stable dose of inhaled medication for COPD for at least 6 weeks.
  • Must be a current or former smoker with a history of smoking at least 10 pack-years. A pack-year is a way to measure how much someone has smoked over time.
  • Must be willing and able to adjust current COPD treatment as needed for the study.
  • Must be willing to visit the study site for all required assessments.
  • Must have a Body Mass Index (BMI) of less than 40 kg/m². BMI is a measure of body fat based on height and weight.
  • Females must meet specific criteria regarding their ability to have children, including using effective birth control if they are of childbearing potential.
  • Must be able to provide signed informed consent, agreeing to follow the study’s requirements and restrictions.

Who Cannot Join the Study?

  • Patients who have a history of severe allergic reactions to any of the study medications.
  • Patients who have had a recent heart attack or stroke.
  • Patients with uncontrolled high blood pressure.
  • Patients with a history of certain heart conditions, such as irregular heartbeat.
  • Patients who are currently using other medications that might interfere with the study drugs.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients with any other medical condition that the study doctors think might make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut für Allergie- und Asthmaforschung Berlin Berlin Germany

Other Sites

Site Name City Country Status
Siteworks GmbH Hanover Germany
IKF Pneumologie GmbH & Co. KG Frankfurt Germany
Velocity Clinical Research Luebeck GmbH Luebeck Germany
Virgen del Rocío University Hospital Sevilla Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hospital Vithas Xanit Internacional Benalmadena Spain
PAREXEL International GmbH Berlin Germany
Hospital General Universitario Gregorio Maranon Madrid Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
27.09.2023
Spain Spain
Not recruiting
27.09.2023

Trial locations

Budesonide is a medication used in this trial to help reduce inflammation in the lungs. It is often used to manage symptoms in people with chronic obstructive pulmonary disease (COPD) by making breathing easier.

Glycopyrronium is included in the trial as a bronchodilator. It helps to open up the airways in the lungs, making it easier for participants with COPD to breathe.

Formoterol Fumarate is another bronchodilator used in the study. It works by relaxing muscles in the airways to improve breathing in people with COPD.

BGF MDI is a combination inhaler that includes Budesonide, Glycopyrronium, and Formoterol Fumarate. This combination is being tested to see how well it helps with breathing and exercise capacity in people with COPD.

BFF MDI is a combination inhaler that contains Budesonide and Formoterol Fumarate. This combination is also being evaluated for its effectiveness in improving breathing and exercise performance in participants with COPD.

Chronic Obstructive Pulmonary Disease – 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 cause shortness of breath, wheezing, and a chronic cough. Over time, the airways and air sacs in the lungs lose their elastic quality, 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. The disease progresses slowly, and symptoms often worsen over time, especially if exposure to lung irritants continues. It is commonly caused by long-term exposure to irritating gases or particulate matter, most often from cigarette smoke.

Trial ID:
2022-502274-16-00
Protocol code:
D5988C00001
Trial Phase:
Human Pharmacology (Phase I) – Other

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