This clinical trial is focused on studying the effects of a medication called Benralizumab on patients with Chronic Obstructive Pulmonary Disease (COPD). COPD is a long-term lung disease that makes it hard to breathe and often gets worse over time. The study is particularly interested in patients who have moderate to very severe forms of COPD and have experienced frequent flare-ups, known as exacerbations, which are sudden worsenings of symptoms. These patients also have higher levels of a type of white blood cell called eosinophils in their blood.
The purpose of the study is to evaluate how well Benralizumab can reduce the number of COPD exacerbations in these patients. Benralizumab is given as an injection under the skin. Some participants will receive Benralizumab, while others will receive a placebo, which looks like the medication but does not contain the active ingredient. The study will compare the effects of Benralizumab to the placebo to see if the medication is effective and safe for patients with COPD.
Participants in the study will receive regular doses of the medication or placebo over a period of time. They will be monitored closely by healthcare professionals to track any changes in their condition and to ensure their safety. The study aims to provide valuable information about the potential benefits of Benralizumab for people living with COPD, particularly those who experience frequent exacerbations and have elevated eosinophil levels.
1enrollment
Upon joining the study, informed consent is required. This means understanding the study details and agreeing to participate.
For women who can become pregnant, a negative pregnancy test is necessary at the first visit. Additionally, agreeing to use a highly effective method of birth control throughout the study and for 12 weeks after the last dose is required.
2initial assessment
An initial assessment will be conducted to confirm eligibility. This includes checking age, smoking history, and medical history related to chronic obstructive pulmonary disease (COPD).
A blood test will be performed to measure eosinophil levels, which are a type of white blood cell.
3randomization
Participants are randomly assigned to receive either the study medication, benralizumab, or a placebo. A placebo is a substance with no active medication, used for comparison.
The study is double-blind, meaning neither the participant nor the study team knows who receives the medication or placebo.
4treatment phase
The treatment involves receiving an injection under the skin (subcutaneous) every 4 weeks for the first 3 doses, then every 8 weeks thereafter.
The medication dose is 100 mg of benralizumab.
5regular visits
Regular visits to the study site are required to monitor health and collect data. This includes checking lung function, symptoms, and any side effects.
Blood samples may be taken to measure the concentration of the medication and check for antibodies.
6end of study
The study is expected to end in June 2025. At the end of the study, a final assessment will be conducted to evaluate health and gather final data.
Participants will be informed about the study results and any further steps if necessary.
Who Can Join the Study?
Provide informed consent, which means you agree to participate after understanding the study details.
If you are a woman who can have children, you must have a negative pregnancy test at the first visit.
Women who can have children must use a highly effective birth control method during the study and for 12 weeks after the last dose of the study medication. Women who cannot have children include those who are permanently sterilized or postmenopausal (confirmed by a specific hormone test for women under 50).
Be between the ages of 40 and 85 years old.
Both men and women can participate.
You must be a current or former smoker with a history of smoking at least 10 pack-years (a pack-year is smoking 20 cigarettes a day for one year).
Have a history of moderate to very severe Chronic Obstructive Pulmonary Disease (COPD), with specific lung function test results showing a post-bronchodilator FEV1/FVC ratio of less than 0.70 and FEV1 less than or equal to 65% of the predicted normal value. 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 a documented history of 2 or more COPD flare-ups that required treatment with systemic corticosteroids (a type of medication) and/or hospitalization within the last 52 weeks before joining the study. Flare-ups treated only with antibiotics are not counted unless they also required corticosteroids or hospitalization. Hospitalization means being admitted to the hospital for at least 24 hours. At least one of these flare-ups should have happened while you were on stable triple therapy for COPD.
Have been using triple therapy for COPD, which includes an inhaled corticosteroid (ICS), a long-acting beta-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), for at least 3 months before joining the study. If you cannot tolerate ICS, using LABA/LAMA is allowed. The ICS dose should be approved for COPD or equivalent to at least 250 micrograms of fluticasone propionate daily. You should have been on stable therapy/doses for the last 3 months before randomization.
Have a blood eosinophil count of at least 300 cells per microliter at screening and a documented historical eosinophil count of at least 150 cells per microliter within 52 weeks of joining the study. Eosinophils are a type of white blood cell.
Have a COPD Assessment Test (CAT) total score of at least 15 at the first visit. The CAT is a questionnaire that measures the impact of COPD on your life.
Who Cannot Join the Study?
Patients with other serious lung diseases cannot participate.
Patients who have had a recent lung infection or illness may not be eligible.
Patients who have used certain medications that affect the immune system recently may be excluded.
Patients with a history of severe allergic reactions to similar medications cannot join.
Patients with certain heart conditions may not be allowed to participate.
Patients who are pregnant or breastfeeding are not eligible.
Patients with a history of cancer within the last 5 years may be excluded, except for some skin cancers.
Patients with uncontrolled high blood pressure may not be eligible.
Patients who have participated in another clinical trial recently may not be allowed to join.
Patients with a history of drug or alcohol abuse may be excluded.
Benralizumab is a medication used in this clinical trial to help people with Chronic Obstructive Pulmonary Disease (COPD). COPD is a lung condition that makes it hard to breathe. This medication works by targeting and reducing certain cells in the blood called eosinophils, which can cause inflammation and worsen COPD symptoms. By lowering the number of these cells, benralizumab aims to reduce the frequency and severity of COPD flare-ups, helping patients breathe easier and improve their quality of life.
Chronic Obstructive Pulmonary Disease (COPD) – Chronic Obstructive Pulmonary Disease is a long-term lung condition that makes it difficult to breathe. It is characterized by a persistent blockage of airflow from the lungs, which is usually progressive. The disease involves the airways and air sacs in the lungs becoming inflamed or damaged, leading to symptoms such as coughing, mucus production, and shortness of breath. Over time, the airways become narrowed, and the lung tissue can be destroyed, further reducing airflow. COPD often includes chronic bronchitis and emphysema, which contribute to the breathing difficulties. The condition can worsen over time, with periods of exacerbation where symptoms become more severe.
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