This clinical trial is focused on studying the safety of a treatment for people with asthma, a condition that affects the airways in the lungs and can cause breathing difficulties. The study will compare two formulations of a medication known by the code name CHF5993. This medication is a combination of three active substances: glycopyrronium bromide, formoterol fumarate dihydrate, and beclometasone dipropionate anhydrous. These substances work together to help open the airways and reduce inflammation, making it easier to breathe. The trial will also use salbutamol as a rescue medication, which is commonly used to quickly relieve asthma symptoms.
The purpose of the study is to evaluate the safety of the two formulations of CHF5993 in people with moderate to severe asthma. Participants will be randomly assigned to one of two groups, each receiving a different formulation of the medication. The study will last for 12 weeks, during which participants will use an inhaler to take their assigned medication. Throughout the study, participants will have regular visits to monitor their health and assess how their lungs are functioning. The study is designed to be double-blind, meaning neither the participants nor the researchers will know which formulation each participant is receiving, to ensure unbiased results.
Participants will be asked to use an electronic diary to record their symptoms and any use of the rescue medication, salbutamol. The study aims to provide valuable information on the safety of the new formulation of CHF5993 and its potential to help people with asthma manage their condition more effectively. The trial will help determine if the new formulation is as safe as the existing one, with a focus on any potential for causing bronchoconstriction, which is a narrowing of the airways that can make breathing difficult.
1Joining the study
Upon joining the study, the participant will be randomly assigned to one of two groups. Each group will receive a different formulation of the same medication, CHF5993, which is used to treat asthma.
The medication is administered using a pressurized inhaler, which delivers a specific dose with each use.
2Medication administration
Participants will use the inhaler twice daily, once in the morning and once in the evening. Each actuation delivers a dose of 200 micrograms of beclometasone dipropionate, 6 micrograms of formoterol fumarate, and 12.5 micrograms of glycopyrronium bromide.
The inhaler should be used as instructed to ensure the correct dosage is administered.
3Regular assessments
Participants will attend regular study visits on Day 1, Day 7, Week 4, and Week 12. During these visits, lung function tests will be conducted to measure the forced expiratory volume (FEV1) at various time points after taking the medication.
These tests help assess the effectiveness and safety of the medication.
4Monitoring and recording
Participants will be required to keep a daily electronic diary to record their asthma symptoms and any use of rescue medication, such as salbutamol.
This information is crucial for evaluating the overall control of asthma symptoms during the study.
5Completion of the study
The study will last for 12 weeks. At the end of this period, a final assessment will be conducted to evaluate the participant’s response to the treatment.
The results will contribute to understanding the safety and effectiveness of the medication formulations being tested.
Who Can Join the Study?
You must give your written consent before any study-related procedures begin.
You should be cooperative and able to learn how to use the inhalers and e-Diary correctly. You should also be able to read and write, perform necessary tests like spirometry (a breathing test), and understand the risks involved. If you already use a spacer device with your inhaler, you will need to continue using it during the study.
If you are a woman who can have children, you must use a reliable birth control method if your partner is fertile. If your partner is not fertile, birth control is not needed. If you are a woman who cannot have children, you must be post-menopausal (no longer having periods) or permanently unable to become pregnant.
You must be between 18 and 75 years old.
Your body mass index (BMI), which is a measure of body fat based on height and weight, should be between 18.0 and 35.0.
You should be a non-smoker or have quit smoking more than a year ago (or more than 6 months ago for e-cigarettes) and have smoked less than 10 pack-years. A pack-year is the number of cigarette packs smoked per day multiplied by the number of years you smoked.
You must have been diagnosed with asthma by a doctor for at least 6 months, and the diagnosis should have been made before you turned 50.
Your asthma treatment should be stable, meaning you have been using medium to high doses of inhaled corticosteroids (ICS) with a long-acting beta-agonist (LABA) and possibly a long-acting muscarinic antagonist (LAMA) for at least 4 weeks before the study. If you use a spacer with your inhaler, you should continue using it during the study.
Your asthma should be controlled or partly controlled, with a score of less than 1.5 on the Asthma Control Questionnaire (ACQ-7) at the start of the study.
Your lung function, measured by forced expiratory volume in 1 second (FEV1), should be between 40% and 90% of the normal value for someone of your age and size, after stopping bronchodilator medication for a short time before the test.
You should have a positive response to a bronchodilator test, which means your FEV1 should increase by at least 12% and 200 mL after using a bronchodilator medication like salbutamol. If this response is not seen at the first test, it can be repeated before the study starts. If still not met, past documentation of a positive response or a positive bronchial challenge test within the last 24 months can be used.
Who Cannot Join the Study?
Patients with asthma that is not well controlled, meaning their symptoms are not managed effectively.
Patients who have other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are currently participating in another clinical trial.
Patients who have had a recent respiratory infection, which is an infection in the lungs or airways.
Patients who have a history of severe allergic reactions.
Patients who are unable to use the inhaler device properly.
Patients who have a known allergy to any of the study medications.
Patients who have smoked tobacco or used nicotine products within the last 6 months.
Patients who have a history of drug or alcohol abuse.
CHF5993 pMDI with HFA-152a is an inhaler medication used in the trial to help manage asthma symptoms. It contains a combination of active ingredients that work together to open up the airways, making it easier to breathe. The HFA-152a refers to the type of propellant used in the inhaler, which helps deliver the medication into the lungs.
CHF5993 pMDI with HFA-134a is another inhaler medication used in the trial, similar to the one with HFA-152a. It also contains the same combination of active ingredients to help relieve asthma symptoms by opening the airways. The difference lies in the type of propellant, HFA-134a, which is used to deliver the medication into the lungs.
Asthma – Asthma is a chronic respiratory condition characterized by inflammation and narrowing of the airways, leading to difficulty in breathing. It often presents with symptoms such as wheezing, coughing, shortness of breath, and chest tightness. The severity of asthma can vary, with some individuals experiencing mild symptoms and others having more severe episodes. Asthma is often triggered by allergens, exercise, cold air, or stress. In moderate to severe cases, as described by the Global Initiative for Asthma (GINA) guidelines, individuals may require regular medication to control symptoms and prevent exacerbations. The condition can fluctuate over time, with periods of stability and episodes of worsening symptoms.
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