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Study on Budesonide for COPD Patients with Different Eosinophil Levels

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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 lung condition that makes it hard to breathe. The study will use a treatment called Budesonide, which is an inhalation powder. Budesonide is a type of medication known as a glucocorticosteroid, which helps reduce inflammation in the lungs.

The purpose of the study is to understand the molecular changes that occur in patients with COPD when treated with Budesonide, especially in relation to their blood eosinophil levels. Eosinophils are a type of white blood cell that can be involved in inflammation. The study will compare these changes in patients who receive Budesonide with those who do not, over a period of eight weeks.

Participants in the study will be monitored for changes in their body at a molecular level, such as in their microbiome, which is the collection of all the microorganisms living in the body, and their transcriptome, which involves the study of RNA molecules. These changes will be observed through samples taken from sputum, nasal and throat swabs, urine, and blood. The study aims to provide insights into how Budesonide affects patients with different severities of COPD and varying levels of eosinophils in their blood.

The research process

The trial runs in 5 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, eligibility is confirmed based on specific criteria such as age, smoking history, and lung function tests.
A signed informed consent form is required to participate.
Step 2
Initial assessment
An initial assessment is conducted to gather baseline data. This includes collecting samples such as sputum, nasal and oropharyngeal swabs, urine, and blood.
These samples help in understanding the current molecular state before treatment begins.
Step 3
Treatment phase
The treatment involves the use of budesonide, an inhaled medication.
The dosage and frequency of budesonide are determined by the study protocol and are administered through inhalation.
This phase lasts for 8 weeks, during which the medication is taken regularly as prescribed.
Step 4
Follow-up assessment
After 8 weeks of treatment, a follow-up assessment is conducted.
Samples are collected again to observe any molecular changes in response to the treatment.
Step 5
Data analysis
The collected data from both initial and follow-up assessments are analyzed to identify significant molecular changes.
These changes are compared to determine the impact of the budesonide treatment on patients with different blood eosinophil counts.

Who can join the trial?

9 criteria

Male and female patients who are **40 years or older**.
Have a history of smoking at least **10 pack-years**. This means the number of packs of cigarettes smoked per day multiplied by the number of years the person has smoked.
Must be a former smoker, having quit smoking for at least **6 months**.
Have a **post-bronchodilator FEV1/FVC ratio** of less than 0.70. This is a measure of lung function, where 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 an **FEV1** between **30% and 80%** of the predicted value, indicating mild to moderate COPD. FEV1 is a measure of how much air you can exhale in one second.
Must sign a written informed consent form, agreeing to participate in the study.
Currently using regular treatment with **dual long-acting bronchodilators (LABA+LAMA)** for at least 8 weeks. These are medications that help open the airways in the lungs.
Women who can have children must have a negative pregnancy test before joining the study and agree to use highly effective birth control methods during the study. These methods include an intrauterine device, having the fallopian tubes blocked, a partner who has had a vasectomy, or choosing not to have sex.
Hormonal birth control methods should be avoided due to the risk of side effects and possible liver function issues.

Who cannot join the trial?

5 criteria

Patients who have a different lung condition other than Chronic Obstructive Pulmonary Disease (COPD). COPD is a long-term lung disease that makes it hard to breathe.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are not male or female, as both genders are included in the study.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.

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Verified sites

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

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Hospital Clinic De Barcelona
Barcelona, Spain
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Philipps-Universitaet Marburg
Marburg, Germany
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Universitair Medisch Centrum Groningen
Groningen, The Netherlands

Trial locations

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Investigated drugs

ICS (Inhaled Corticosteroids) are medications used to reduce inflammation in the airways, making it easier to breathe. They are commonly used in the treatment of chronic obstructive pulmonary disease (COPD) to help manage symptoms and prevent flare-ups. In this trial, the focus is on understanding how these medications affect patients with varying levels of eosinophils, a type of white blood cell, in their blood.

Budesonide

What is already known about the treatment

Inhaled Corticosteroids (ICS) – This medication is administered through inhalation, allowing the drug to directly reach the lungs. It is currently well-established in medical practice and literature for managing respiratory conditions. The main therapeutic indication for ICS is chronic obstructive pulmonary disease (COPD), particularly in patients with varying levels of eosinophils in their blood. At the molecular level, ICS works by reducing inflammation in the airways, which helps to ease breathing difficulties. It belongs to the pharmacological class of corticosteroids, which are known for their anti-inflammatory properties.

Investigated diseases

Chronic Obstructive Pulmonary Disease (COPD) – A long-term lung condition that causes breathing difficulties due to airflow obstruction. It typically involves two main conditions: chronic bronchitis and emphysema. Chronic bronchitis is characterized by a persistent cough with mucus, while emphysema involves damage to the air sacs in the lungs. Over time, COPD can lead to increased breathlessness, frequent coughing, and wheezing. The disease progresses gradually, often worsening over years, and can be influenced by factors such as smoking and environmental pollutants. As it advances, daily activities may become more challenging due to reduced lung function.