Study on Reducing Inhaled Corticosteroids and Using Azithromycin for Patients with Severe COPD

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What is this study about?

This clinical trial is focused on studying *Chronic Obstructive Pulmonary Disease (COPD)*, a lung condition that makes it hard to breathe. The study is exploring the effects of reducing the use of *inhaled corticosteroids*, which are medications that help reduce inflammation in the lungs, in a way that is guided by the levels of a type of white blood cell called eosinophils. Additionally, the study is examining the use of a low dose of *azithromycin*, an antibiotic, to see if it can help reduce the number of hospital admissions due to worsening COPD symptoms or death over a year, compared to a placebo.

The purpose of the study is to determine if these treatment strategies can be effective for patients with severe COPD. Participants in the study will receive either the inhaled corticosteroids or azithromycin, or a placebo, and their health will be monitored over a period of up to one year. The study aims to see if these treatments can help manage COPD symptoms without causing a loss of treatment effectiveness.

Throughout the study, participants will have regular check-ups to monitor their lung function, blood eosinophil levels, and overall health. The study will also track any changes in quality of life related to COPD, the need for additional medications, and any new health conditions that may arise. The goal is to find the best way to manage COPD symptoms and improve the quality of life for those affected by this condition.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose and procedures. You will be asked to provide your informed consent, which means you agree to participate after understanding the details of the study.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes verifying your diagnosis of chronic obstructive pulmonary disease (COPD) and reviewing your medical history, including any recent hospitalizations related to COPD.

3 medication regimen

You will be assigned to receive either Azithromycin or a placebo. Azithromycin is administered as a film-coated tablet taken orally. The dosage and frequency will be determined by the study team and will be explained to you in detail.

The treatment will last for up to 365 days, during which you will be monitored for any changes in your health, including the number of COPD exacerbations and hospitalizations.

4 regular follow-ups

Throughout the study, you will have regular follow-up visits. These visits will occur every three months to assess your health status, lung function, and any side effects from the medication.

During these visits, your blood eosinophil levels will be checked, and you will be asked to complete a COPD Assessment Test (CAT) to evaluate your quality of life.

5 end of study evaluation

At the end of the 365-day period, a final evaluation will be conducted. This will include a comprehensive review of your health, any changes in your lung function, and the overall impact of the treatment on your COPD symptoms.

The study team will discuss the results with you and provide any necessary follow-up care or recommendations.

Who Can Join the Study?

Have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD), confirmed by a lung specialist and a breathing test called spirometry.
Have been classified in the GOLD risk class C or D at any time in the last 2 years. This means having 2 or more flare-ups of COPD or at least 1 flare-up that required hospitalization in a 12-month period within the last 2 years, or having a FEV1 (a measure of lung function) of less than 30%.
Must have been taking the following medications for at least the last 4 weeks: LAMA (a long-acting muscarinic antagonist), LABA (a long-acting beta-agonist), and ICS (inhaled corticosteroids).
Must provide informed consent, which means agreeing to participate in the study after understanding all the details and risks involved.
Both male and female participants are eligible.

Who Cannot Join the Study?

Patients with a history of severe allergic reactions to any of the study medications.
Patients who are currently participating in another clinical trial.
Patients with a history of drug or alcohol abuse within the past year.
Patients with any other significant lung disease besides Chronic Obstructive Pulmonary Disease (COPD).
Patients with a history of heart disease that is not well controlled.
Patients who have had a major surgery within the last 3 months.
Patients who are pregnant or breastfeeding.
Patients with a history of cancer within the last 5 years, except for skin cancer that is not melanoma.
Patients with a known infection that requires treatment with antibiotics.
Patients who are unable to follow the study procedures or attend the required visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Sydvestjysk Sygehus	Esbjerg	Denmark

Other Sites

Site Name	City	Country
Rigshospitalet	Roenne	Denmark
Region Midtjylland	Aarhus	Denmark
Gentofte Hospital	Hellerup	Denmark
Næstved Hospital	Næstved	Denmark
Odense University Hospital	Odense	Denmark
Zealand University Hospital	Koege	Denmark
Nordsjaellands Hospital	Hillerød	Denmark
Hhnkmzjh Hfvdutny	Hvidovre	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	26.07.2022

Trial locations

Investigated drugs:

Azithromycin

Inhaled Corticosteroids (ICS) are medications used to help people with Chronic Obstructive Pulmonary Disease (COPD) breathe better. They work by reducing inflammation in the lungs, which can help prevent flare-ups and make breathing easier. In this study, the use of these medications is guided by the level of a type of white blood cell called eosinophils. This approach aims to maintain the effectiveness of the treatment without unnecessary use of the medication.

Azithromycin is an antibiotic that is sometimes used in low doses to help people with COPD. In this study, it is being tested to see if it can reduce the number of times patients need to be admitted to the hospital due to worsening symptoms or if it can lower the risk of death from any cause over a year. The idea is that by taking this medication, patients might experience fewer severe episodes of their disease.

Investigated diseases:

Chronic obstructive pulmonary disease

Chronic obstructive pulmonary disease (COPD) – Chronic obstructive pulmonary disease is a long-term lung condition that causes breathing difficulties. It is characterized by persistent respiratory symptoms and airflow limitation due to airway and/or alveolar abnormalities. The disease progresses with increasing breathlessness, frequent coughing, and production of sputum. Over time, the airways become inflamed and narrowed, and the lung tissue is damaged, leading to reduced airflow. COPD often involves episodes of worsening symptoms known as exacerbations, which can be triggered by infections or environmental factors. As the disease advances, it can significantly impact daily activities and quality of life.

Trial ID:

2022-501035-16-01

Protocol code:

COPERNICOS

NCT ID:

NCT04481555

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Reducing Inhaled Corticosteroids and Using Azithromycin for Patients with Severe COPD

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?