This clinical trial is focused on studying a lung condition called Chronic Obstructive Pulmonary Disease (COPD). COPD is a long-term disease that makes it hard to breathe. The study is testing two different treatments to see which one works better for people with COPD. The first treatment is a combination of three medications: Beclometasone Dipropionate, Formoterol Fumarate, and Glycopyrronium Bromide, known by the code name CHF 5993. The second treatment is a combination of two medications: Beclometasone Dipropionate and Formoterol Fumarate, known by the code name CHF 1535. Both treatments are given using a special inhaler called a Pressurised Metered Dose Inhaler (pMDI).
The purpose of the study is to compare the effectiveness, safety, and how well people tolerate these two treatments. Participants in the study will be randomly assigned to receive either CHF 5993 or CHF 1535. The study will last for 52 weeks, during which participants will use the inhaler daily. Throughout the study, participants will have regular check-ups to monitor their lung function and overall health. The main goal is to see if CHF 5993 can improve lung function before taking the daily dose compared to CHF 1535.
Participants will also be monitored for any side effects or health issues that may arise during the study. This includes tracking any worsening of COPD symptoms, known as exacerbations, and any other health events. The study aims to provide valuable information on which treatment may be more beneficial for people living with COPD.
1joining the study
Upon joining the study, the participant will begin by using a pressurized metered dose inhaler (pMDI) for inhalation. This device is used to administer the medications directly to the lungs.
The study involves two different medications: CHF 5993 and CHF 1535. Both are solutions for inhalation.
2medication administration
Participants will be randomly assigned to receive either the triple combination medication CHF 5993 or the dual combination medication CHF 1535.
Both medications are administered via the pMDI device. The specific dosage and frequency will be determined by the study protocol.
3monitoring and assessments
Throughout the 52-week study period, participants will undergo regular monitoring to assess lung function and overall health.
The primary focus is on the change in lung function, specifically the pre-dose morning FEV1, which is a measure of how much air can be forcefully exhaled in one second.
4evaluation of outcomes
At week 28, a key assessment will be conducted to evaluate changes in lung function from the baseline.
Secondary outcomes include the rate of moderate and severe COPD exacerbations, quality of life assessments, and the incidence of any adverse events.
5completion of the study
The study is expected to conclude by August 2025. Participants will have a final evaluation to assess the overall impact of the treatment on their COPD condition.
The results will help determine the efficacy and safety of the medications used in the study.
Who Can Join the Study?
You must sign a written consent form before starting any study-related activities.
You should be using daily inhaled medication for your COPD and have been on a stable dose for at least 3 months before the study starts.
You need to have a chest x-ray or CT scan done within 6 months before the study starts, showing no major issues other than COPD.
You should be willing to cooperate and able to use the inhalers and electronic diary correctly.
You must be an outpatient, meaning you are not currently admitted to a hospital.
You should be a male or female aged over 40 years.
If you are a woman who can have children, certain conditions about your partner’s fertility may apply.
You need to have been diagnosed with COPD for at least 12 months before the study starts, according to the GOLD 2020 Report.
You should be a current or former smoker who quit smoking at least 6 months before the study, 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.
You must have symptoms of COPD with a score of 10 or more on the COPD Assessment Test (CAT).
Your lung function test should show a FEV1/FVC ratio of less than 0.70 after using a bronchodilator during screening. This test measures how well your lungs are working.
Your lung function test should show a post-bronchodilator FEV1 of less than 50% of the predicted normal value, with at least one moderate or severe COPD flare-up in the past year, or a post-bronchodilator FEV1 between 50% and 80% of the predicted normal value, with at least two moderate or one severe COPD flare-up in the past year. The Global Lung Function Initiative reference equations will be used to calculate these values.
Who Cannot Join the Study?
Patients with a history of allergic reactions to any of the study medications cannot participate. An allergic reaction is when your body reacts badly to something, causing symptoms like rash, itching, or trouble breathing.
Individuals who have had a lung infection in the last 4 weeks are not eligible. A lung infection can cause symptoms like cough, fever, and difficulty breathing.
People who have been hospitalized for heart problems in the past 6 months cannot join. Heart problems can include conditions like heart attacks or heart failure.
Participants who are currently using other experimental drugs are excluded. Experimental drugs are medications that are still being tested and are not yet approved for general use.
Women who are pregnant or breastfeeding are not allowed to participate. Pregnancy and breastfeeding involve carrying and feeding a baby, which can affect how medications work in the body.
Patients with uncontrolled high blood pressure are not eligible. High blood pressure means the force of blood against your artery walls is too high, which can lead to health problems.
Individuals with a history of substance abuse in the past year are excluded. Substance abuse refers to the harmful use of substances like drugs or alcohol.
People who have participated in another clinical trial in the last 30 days cannot join. A clinical trial is a research study to test new treatments or medications.
Beclomethasone Dipropionate: This medication is a type of steroid that helps reduce inflammation in the lungs. It is used to help improve breathing in people with chronic obstructive pulmonary disease (COPD).
Formoterol Fumarate: This is a long-acting bronchodilator that helps to relax muscles in the airways, making it easier to breathe. It is used in combination with other medications to manage symptoms of COPD.
Glycopyrronium Bromide: This medication is a long-acting muscarinic antagonist (LAMA) that helps to open up the airways by blocking certain receptors in the lungs. It is used to improve breathing in people with COPD.
CHF 5993: This is a combination of three medications—beclomethasone dipropionate, formoterol fumarate, and glycopyrronium bromide. It is used to improve lung function and manage symptoms in people with COPD.
CHF 1535: This is a combination of two medications—beclomethasone dipropionate and formoterol fumarate. It is used to help improve breathing and manage symptoms in people with COPD.
Chronic Obstructive Pulmonary Disease (COPD) – This is a long-term lung disease that makes it hard to breathe. It is characterized by a persistent blockage of airflow from the lungs, which is usually progressive. The disease often involves symptoms such as chronic cough, mucus production, and shortness of breath. Over time, the airways and air sacs in the lungs lose their elastic quality, and the walls between many of the air sacs are destroyed. The walls of the airways become thick and inflamed, and the airways make more mucus than usual, which can clog them. This condition is primarily caused by long-term exposure to irritating gases or particulate matter, most often from cigarette smoke.
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