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Erdosteine in Patients With COPD

Verified siteRegistered drugNo placebo

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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 studying Chronic Obstructive Pulmonary Disease (COPD), a long-term lung disease that makes breathing difficult. The treatment being tested is erdosteine, given as an oral capsule, together with usual medical care. The purpose of the study is to see how erdosteine may affect body changes linked to inflammation, stress in the body’s cells, and immune system activity in people with COPD.

The study has two groups. One group receives erdosteine plus standard care, and the other group receives standard care alone. The study lasts about 4 weeks. During this time, blood samples are taken before and after treatment so researchers can compare changes in substances and cell signals related to lung disease, inflammation, and the immune system. These include GPX2, a body protein linked to protection against cell damage, as well as other signs of immune activity and oxidative stress, which means damage caused by harmful molecules in the body.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Start of treatment
You begin the study in one of two treatment groups. In treatment arm a, you take erdosteine by mouth as 600 mg per day. This is given as 2 capsules of 300 mg each, taken once daily for 30 days.
In treatment arm b, you do not receive erdosteine and receive standard of care only. standard of care means the usual treatment given for your condition.
Step 2
During the 30-day treatment period
You continue the assigned treatment for the full 30-day period.
If you are in treatment arm a, you keep taking erdosteine 600 mg by mouth once daily throughout this period.
If you are in treatment arm b, you continue with standard of care only throughout this period.
Step 3
End of treatment assessment after 30 days
At the end of the 30 days, your blood is tested to measure gpx2, which is a body marker linked to protection against damage from harmful substances.
The blood test also measures other markers related to the body's response to inflammation and stress from harmful substances.
A further blood test checks the activity of certain immune cells, including th1, th17, and treg cells. These are types of white blood cells that help control the body's defense responses.

Who can join the trial?

9 criteria

Age 45 years or older.
A confirmed diagnosis of COPD based on a breathing test called spirometry, with the result showing FEV1/FVC less than 0.7 after using a bronchodilator (a medicine that opens the airways). This diagnosis must have been made at least 12 months before joining the study.
Stable symptoms, meaning no flare-ups and no respiratory infections of any severity in the 3 months before joining the study.
Moderate to severe airflow obstruction, meaning the breathing test after bronchodilator shows FEV1 between 30% and 80% of the expected value. FEV1 is the amount of air a person can force out in one second.
No hospital stay for any reason in the 3 months before joining the study.
Ability to do repeatable pulmonary function tests, meaning breathing tests that can be performed reliably more than once.
Being on chronic inhaled therapy with either LAMA/LABA or LAMA/LABA/ICS, with no change in dose during the 3 months before joining the study. LAMA and LABA are inhaled medicines that help keep airways open, and ICS is an inhaled steroid that reduces swelling in the airways.
Being an ex-smoker, with a smoking history of at least 10 pack-years. A pack-year means smoking 20 cigarettes a day for 1 year.
Male or female.

Who cannot join the trial?

15 criteria

Heart failure in NYHA class III or IV, which means severe heart failure that causes marked limitation of normal activities or symptoms even at rest.
Chronic kidney failure with creatinine clearance below 25 mL/min, which means the kidneys are not filtering blood well enough.
Being an active smoker or a never smoker.
Any signs of an active infection in the body or lungs, or a positive history of such an infection in the last 3 months before screening and enrollment.
Current use of any mucolytic or antioxidant medicine, which are medicines that help loosen mucus or protect cells, including erdosteine, N-acetylcysteine, carbocysteine, ambroxol, or bromhexine.
A known allergy or hypersensitivity to erdosteine or any ingredient in the study medicine.
Women of childbearing potential, meaning women who could become pregnant.
Unstable arrhythmia, which means an irregular heartbeat that is not well controlled.
Active malignancy, meaning an active cancer of a solid organ or blood.
Long-term treatment with systemic corticosteroids or immunosuppressants, which are medicines that reduce inflammation or weaken the immune system throughout the body.
Immune depression, meaning the immune system is weaker than normal.
A known hypersensitivity to erdosteine.
Pregnancy or breastfeeding.
Active peptic ulcer, which means an open sore in the stomach or upper intestine that is currently present.
Liver problems, including hepatic insufficiency (the liver is not working properly), liver cirrhosis (scarring of the liver), or known cystathionine-synthase deficiency (a rare inherited condition affecting how the body processes certain proteins).

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ASST Fatebenefratelli Sacco
Milan, Italy

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Investigated drugs

Erdosteine is the study medicine being tested in this trial. It is taken by mouth and is used together with the usual standard care for chronic obstructive pulmonary disease (COPD). In this study, it is being given to see whether it can help reduce harmful oxidative stress, lower inflammation, and support the body’s immune response in people with COPD.

What is already known about the treatment

Erdosteine - Erdosteine is taken by mouth as hard capsules, and the capsules are swallowed with water as directed by a doctor. It is a medicine used mainly for lung and airway problems, especially chronic obstructive pulmonary disease (COPD), where it can help thin mucus and make coughing it up easier. In medical literature, it is an established mucolytic and antioxidant medicine, meaning it helps break up thick mucus and may also help protect cells from damage caused by harmful molecules. It works by being changed in the body into active forms that can break bonds in mucus and may reduce inflammation and support the body’s natural defense systems.

Investigated diseases

Chronic obstructive pulmonary disease - Chronic obstructive pulmonary disease is a long-term lung disease that makes it hard to move air in and out of the lungs. It usually develops slowly and causes ongoing narrowing of the airways and damage to the air sacs. Over time, symptoms such as shortness of breath, cough, and mucus production often become more persistent. The condition commonly worsens gradually, with periods when symptoms suddenly get worse.