Comparison of CHF5993 (glycopyrronium bromide, formoterol fumarate dihydrate, and beclometasone dipropionate) and a drug combination for patients with mild to moderate asthma
This study is being conducted to evaluate the therapeutic equivalence of a new medication compared to existing treatments in people with mild to moderate asthma, a long-term condition that affects the airways in the lungs. The study involves the use of an inhaled medication known as CHF5993 pMDI, which contains three active ingredients: glycopyrronium bromide, formoterol fumarate dihydrate, and beclometasone dipropionate. This combination is delivered through a pressurised inhalation solution, which is a device used to breathe medicine directly into the lungs.
Participants will be compared against two other options. One option is Trimbow, which contains the same three active ingredients. The other comparison involves using beclometasone dipropionate alone. Some individuals may also receive a placebo. The study uses a cross-over design, meaning that participants will receive different treatments at different times during the course of the study to see how each one affects their breathing.
One of the main ways the study looks at how well the medicine works is by measuring the forced expiratory volume in 1 second, which is a test that calculates how much air a person can exhale quickly to check lung function. The study tracks these changes over a period of time to see how the different inhaled medications affect breathing capacity and overall control of the condition.
Who Can Join the Study?
You must agree to participate in the study by signing a consent form, which is a document that explains all the study details before any tests begin.
You must be able to use a salbutamol (also known as albuterol) inhaler, which is a rescue medication used to quickly open airways during an asthma attack, instead of your usual quick-relief medicine.
You must be able to safely stop taking your current asthma medicines, such as ICS (inhaled corticosteroids, which reduce swelling in the lungs) or LABA (long-acting beta-agonists, which help keep airways open for a long time), for a short period and for the rest of the study.
You must be able to use the study inhaler directly without using a spacer, which is a holding chamber attached to an inhaler to help deliver medicine more easily.
You must be willing and able to learn how to use the pMDI (pressurized metered-dose inhaler, a common type of spray inhaler) and an electronic diary (a digital tool to record daily information).
You must be able to read and write, perform all study tasks, use spirometry (a test that measures how much air you can breathe in and out and how fast), and understand the risks.
Women who may become pregnant must use a highly effective form of birth control, or women who cannot become pregnant may join.
You must be an adult, aged between 18 and 75 years old.
Your Body Mass Index (BMI), which is a measure of your weight relative to your height, must be between 18.0 and 35.0.
You must be a non-smoker or a former smoker who has smoked less than 10 pack-years (a calculation of smoking history based on how many packs per day were smoked over many years).
You must have been diagnosed with asthma by a doctor for at least 6 months and received this diagnosis before the age of 50.
You must have been on a stable asthma treatment for at least 4 weeks using low or medium doses of ICS alone or combined with LABA.
Your asthma must be considered controlled or partly controlled, meaning your symptoms are mostly managed, based on a specific questionnaire score of less than 1.5.
Your lung function, specifically your FEV1 (the amount of air you can forcefully blow out in one second), must be between 40% and 90% of what is considered normal for a person of your age and size.
You must show bronchodilator responsiveness, which means your airways must open up significantly (an increase in air volume of more than 12% and 200 mL) within 30 minutes after using a salbutamol inhaler.
Who Cannot Join the Study?
A history of high-risk asthma, which means having had a life-threatening asthma attack, being admitted to the intensive care unit, or visiting the emergency room for asthma in the last 6 months.
Any significant problems found during an electrocardiogram (ECG), which is a test that records the electrical activity of your heart.
Specific heart rhythm measurements called QTcF being too long; for men, this means a measurement over 450 milliseconds, and for women, over 470 milliseconds.
Having other uncontrolled or severe illnesses, or abnormal results in haematology (blood tests), clinical chemistry (tests looking at chemicals in the blood), or urinalysis (urine tests).
Conditions that make it unsafe to use anticholinergic agents (medicines that can affect certain body functions), such as narrow-angle glaucoma (a type of eye pressure problem), prostatic hypertrophy (an enlarged prostate), urinary retention (difficulty emptying the bladder), or bladder neck obstruction (a blockage when urinating).
Taking certain medications within 4 weeks before the study, such as non-selective β2-blockers (medicines often used for heart or blood pressure issues), quinidine (a heart rhythm medicine), tricyclic anti-depressants, monoamine oxidase inhibitors (a type of antidepressant), cytochrome P450 3A4 inhibitors (medicines that change how the body processes other drugs), or certain diuretics (water pills).
Having a known hypersensitivity (an allergic reaction) to any of the ingredients used in the study treatments.
Taking any non-permitted concomitant medications, which are other medicines that are not allowed to be taken during the study.
Evidence of candidiasis (a fungal infection, often called thrush) in the mouth or throat.
A recent diagnosis of COVID-19 within the last 2 weeks, or having symptoms that have not fully gone away.
A recent asthma exacerbation (a sudden worsening of asthma symptoms) that required systemic corticosteroids (steroid medicines that work throughout the entire body), or any emergency room or hospital visit for asthma in the last 3 months.
A known or suspected history of alcohol or substance abuse within the last 12 months.
Being part of another investigational study (a clinical trial testing new drugs) or having taken an experimental drug recently.
Being pregnant or lactating (breastfeeding).
Failing to follow the rules of the run-in period, such as not completing the electronic diary or not taking the required study medicines correctly more than 25% of the time.
Having received a vaccination within the 2 weeks before starting the study.
Having non-persistent asthma, which is asthma triggered only by exercise or seasons that does not require daily medicine to control.
Currently using certain asthma treatments, including high dose ICS (inhaled corticosteroids), LAMA (long-acting muscarinic antagonists), systemic or slow-release corticosteroids within the last 12 weeks, certain other asthma medicines within 4 weeks, or biologic therapy (specialized medicines targeted at specific parts of the immune system) within the last 6 months.
Having any other respiratory disorder (breathing problem) besides asthma that might interfere with the study results.
A history of lung resection, which means having had a large part of a lung surgically removed.
A recent lower respiratory tract infection (an infection in the lungs or airways) that required antibiotics and has not cleared up within 4 weeks.
Having lung cancer or a history of it.
Having any other type of active cancer or a history of cancer where it has been less than 5 years since the person was healthy and cancer-free.
CHF5993 is an inhaled combination therapy being tested to see how well it works for people with asthma. It contains three different types of medicine: one to reduce swelling and irritation in the airways, one to relax the muscles around the airways, and one to help keep the airways open for a longer period.
Beclometasone is an inhaled medicine used to reduce inflammation and swelling in the airways, which helps make breathing easier for people with asthma.
Trimbow is an inhaled combination treatment that contains three different active medicines. It works by reducing airway swelling, relaxing the muscles around the airways, and helping to keep the airways open to improve breathing.
Asthma – This is a long-term condition that affects the airways in the lungs. It occurs when the tubes that carry air into and out of the lungs become swollen and narrow. This swelling can cause the muscles around the airways to tighten, making it difficult to breathe. Over time, these changes can lead to increased sensitivity to various triggers. The condition often involves periods where symptoms are controlled followed by periods of increased airway irritation.
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