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Study on Atorvastatin for Reducing COPD Exacerbations in Smokers with Chronic Obstructive Pulmonary Disease

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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 the effects of a medication called Atorvastatin in people who have Chronic Obstructive Pulmonary Disease (COPD). COPD is a long-term lung disease that makes it hard to breathe. The study aims to see if Atorvastatin can help reduce the number of times patients experience worsening symptoms, known as exacerbations. Atorvastatin is a type of medication commonly used to lower cholesterol, but this study is exploring its potential benefits for people with COPD. Participants in the study will either receive Atorvastatin or a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to compare how well Atorvastatin works against a placebo in reducing COPD exacerbations. Participants will take the medication or placebo for a period of time, and researchers will monitor their health to see how often exacerbations occur and how long they last. The study will also look at other health aspects, such as lung function, quality of life, and certain markers in the blood that indicate inflammation. These markers include things like the number of white blood cells and levels of proteins that can show how the body is responding to the disease.

Throughout the study, participants will have regular check-ups to assess their lung function and overall health. This includes measuring how much air they can breathe out in one second, known as forced expiratory volume (FEV1), and how far they can walk in six minutes. The study will also track any hospital visits related to COPD. By the end of the study, researchers hope to better understand whether Atorvastatin can be a helpful treatment for people with COPD, potentially improving their quality of life and reducing the frequency of exacerbations.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to sign an Informed Consent Form. This form confirms that you understand the purpose and procedures of the study and agree to participate.

    You must be at least 40 years old and have a history of smoking for at least 10 pack years. This means you have smoked the equivalent of one pack a day for ten years.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm that you have chronic obstructive pulmonary disease (COPD) with specific airflow limitations. This involves a breathing test to measure how well your lungs are working.

    Your medical history will be reviewed to ensure you have experienced at least two moderate or severe COPD exacerbations, or one that required hospitalization, in the past year.

  3. Step 3

    Medication administration

    You will be randomly assigned to receive either atorvastatin or a placebo. Atorvastatin is a medication used to lower cholesterol and may help reduce COPD exacerbations.

    The dosage for atorvastatin is 40 mg, taken orally in the form of a film-coated tablet. You will take this medication once daily for the duration of the study.

  4. Step 4

    Regular monitoring

    Throughout the study, you will have regular check-ups to monitor your health and the effects of the medication. This includes measuring your lung function, checking your blood pressure, and assessing your overall health.

    Blood samples will be taken to analyze changes in inflammatory markers and gene expression related to COPD.

  5. Step 5

    Reporting symptoms

    You will be asked to report any symptoms or changes in your condition, especially any exacerbations of COPD. This helps in assessing the effectiveness of the treatment.

    Keep track of any hospital visits or changes in your health status and communicate these to the study team during your visits.

  6. Step 6

    Completion of the study

    The study is expected to continue until December 31, 2025. Upon completion, a final assessment will be conducted to evaluate your health and the outcomes of the treatment.

    You will receive information about the study results and any potential next steps regarding your health care.

Who can join the trial?

6 criteria

  • The patient must have signed an Informed Consent Form, which means they agree to participate in the study and understand what it involves.
  • The patient must be a male or female aged 40 years or older.
  • The patient must be able to follow the study instructions and complete the study as planned.
  • The patient must have stable COPD with ongoing breathing difficulties. This is measured by a test called post-bronchodilator FEV1, which should be less than 80% of the normal value, and a FEV1/FVC ratio of less than 0.70. These are lung function tests that help determine the severity of COPD.
  • The patient must have had at least two moderate or severe COPD flare-ups, or at least one that required hospitalization or admission to an intensive care unit, in the 12 months before the screening visit.
  • The patient 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. It is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked. Note that using only e-cigarettes or IQOS tobacco heating systems does not count as smoking in this context.

Who cannot join the trial?

3 criteria

  • Patients who do not have Chronic Obstructive Pulmonary Disease (COPD) cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
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Investigated drugs

Atorvastatin is a medication commonly used to lower cholesterol levels in the blood. In this clinical trial, it is being tested to see if it can help reduce the number of flare-ups or worsening of symptoms in people with chronic obstructive pulmonary disease (COPD). The researchers want to find out if atorvastatin can have additional benefits beyond its usual role in managing cholesterol, particularly in people who smoke and have COPD. By potentially reducing these flare-ups, atorvastatin might help improve the quality of life for these patients.

What is already known about the treatment

Atorvastatin – Atorvastatin is taken orally in the form of a tablet. It is currently being studied for its potential benefits in reducing flare-ups in people with chronic obstructive pulmonary disease (COPD). The main therapeutic use of atorvastatin is to lower cholesterol, but it is also being explored for its ability to prevent cancer and provide other health benefits in smokers with COPD. At the molecular level, atorvastatin works by blocking an enzyme in the liver that is responsible for making cholesterol, which helps reduce inflammation and may have protective effects on the lungs. It is classified as a statin, which is a type of medication used to manage cholesterol levels.

Investigated diseases

Chronic obstructive pulmonary disease (COPD) – Chronic obstructive pulmonary disease is a progressive lung condition characterized by persistent respiratory symptoms and airflow limitation. It primarily involves two main conditions: emphysema, which damages the air sacs in the lungs, and chronic bronchitis, which causes inflammation and narrowing of the bronchial tubes. Over time, COPD leads to difficulty breathing, frequent coughing, and increased mucus production. The disease progresses with worsening lung function, making physical activities increasingly challenging. Exacerbations, or flare-ups, can occur, leading to a sudden worsening of symptoms. These exacerbations can further accelerate the decline in lung function.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516714-37-00Protocol code2019/ABM/01/00074Estimated enrolment480 patientsSponsorAgencja Badań Medycznych

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