Study on the Effects of Tezepelumab on Airway Inflammation 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 a medication called Tezepelumab on patients with Chronic Obstructive Pulmonary Disease (COPD). COPD is a long-term lung disease that makes it hard to breathe. The study aims to understand how Tezepelumab can help reduce inflammation in the airways, which is a common problem for people with COPD. Inflammation in the airways can lead to breathing difficulties and other symptoms.

Participants in the study will receive either Tezepelumab or a placebo, which is a substance with no active medication. The study is designed to be “double-blind,” meaning neither the participants nor the researchers will know who is receiving Tezepelumab and who is receiving the placebo. This helps ensure that the results are not influenced by expectations about the treatment. The study will last for a period of 20 weeks, during which the effects of the medication on airway inflammation will be closely monitored.

The main goal of the study is to evaluate how Tezepelumab affects a specific type of inflammation in the bronchial tissue, which is part of the airways. By understanding this, researchers hope to find better ways to manage COPD and improve the quality of life for those affected by this condition. Participants will receive the medication through a subcutaneous injection, which means it is given under the skin. The study will help gather important information about the potential benefits of Tezepelumab for people living with COPD.

1 joining the study

Upon joining the study, participation is confirmed based on specific criteria. These include having chronic obstructive pulmonary disease (COPD), being on certain medications, having experienced at least one exacerbation in the past year, and being 40 years or older.

2 initial assessment

An initial assessment is conducted to establish baseline health status. This includes measuring lung function, specifically the forced expiratory volume (FEV1), which should be between 30% and 80% of the predicted value.

3 randomization and treatment

Participants are randomly assigned to receive either the active medication, tezepelumab, or a placebo. Both are administered via subcutaneous injection. The frequency and dosage are determined by the study protocol.

4 treatment period

The treatment period lasts for 20 weeks. During this time, regular monitoring and assessments are conducted to evaluate the effect of the treatment on airway inflammation and immune response.

5 final assessment

At the end of the 20-week treatment period, a final assessment is conducted. This includes measuring changes in eosinophil cell counts in the bronchial tissue, which is a primary endpoint of the study.

6 completion of study

The study is estimated to conclude by July 31, 2025. Participants will have completed all required assessments and treatments by this date.

Who Can Join the Study?

Must have chronic obstructive pulmonary disease (COPD), which is a long-term lung condition that makes it hard to breathe.
Must be taking medications called LABA (long-acting beta-agonists) and LAMA (long-acting muscarinic antagonists), with or without ICS (inhaled corticosteroids). These are treatments to help manage COPD.
Must have had at least one exacerbation in the past 12 months. An exacerbation is a worsening of symptoms that may require additional treatment.
Must have a postbronchodilator FEV1 (forced expiratory volume in one second) that is 30% or more of what is predicted for a healthy person, but less than 80%. FEV1 is a measure of how much air you can forcefully exhale in one second after using a bronchodilator, which is a medication that helps open the airways.
Must be able to exhale at least 1.0 liter of air in one second after using a bronchodilator.
Must be 40 years or older.
Both male and female participants are eligible.

Who Cannot Join the Study?

Patients with other serious lung diseases besides chronic obstructive pulmonary disease (COPD). COPD is a long-term lung condition that makes it hard to breathe.
Patients who have had a recent lung infection or illness.
Patients who are currently using certain medications that might interfere with the study.
Patients with a history of severe allergic reactions to medications.
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?

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Other Sites

Site Name	City	Country	Status
Rxqiynhevey Raspceuk udkyj Bsjzeoldim Hqcezdvq	Copenhagen	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.06.2024

Trial locations

Investigated drugs:

Tezepelumab is a medication being studied for its potential to reduce inflammation in the airways of patients with COPD (Chronic Obstructive Pulmonary Disease). It works by blocking a specific protein called TSLP, which is involved in the body’s immune response and can contribute to inflammation. The goal of using tezepelumab in this trial is to see if it can help decrease the inflammation in the bronchial tissues, which may improve symptoms and reduce the frequency of exacerbations in patients with COPD.

Investigated diseases:

Chronic obstructive pulmonary disease

Chronic Obstructive Pulmonary Disease – This is a long-term lung condition that makes it difficult to breathe due to airflow blockage. It typically involves two main conditions: emphysema, which damages the air sacs in the lungs, and chronic bronchitis, which causes long-term inflammation of the airways. Over time, individuals with this disease may experience worsening symptoms such as persistent cough, increased mucus production, and shortness of breath. The disease progresses gradually, often leading to decreased lung function and increased difficulty in performing daily activities. Environmental factors like smoking and exposure to pollutants can contribute to its development and progression. Regular monitoring and lifestyle adjustments are important to manage the condition effectively.

Trial ID:

2024-511730-12-00

Protocol code:

ESR-21-21168

NCT ID:

NCT05507242

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Tezepelumab on Airway Inflammation in Patients with Chronic Obstructive Pulmonary Disease (COPD)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?