Asthma in adults: beclometasone dipropionate, formoterol fumarate dihydrate, and glycopyrronium bromide compared with beclometasone dipropionate and formoterol fumarate dihydrate
This study is being done in people with Asthma to compare two inhaled treatments and see which one may provide better control of the disease over time. The treatments are Trimbow 87/5/9, which contains beclometasone dipropionate, glycopyrronium bromide, and formoterol fumarate dihydrate, and Fostair 200/6, which contains beclometasone dipropionate and formoterol fumarate dihydrate. Beclometasone is a steroid medicine that helps reduce swelling in the airways, formoterol helps open the airways, and glycopyrronium helps keep the airways open for longer.
The study is planned to last about 12 months for each person. It compares the two inhaled medicines in a random way, and the treatment is given through an inhaler. During the study, asthma symptoms and general control of asthma are checked at several visits, and the treatment is continued while these checks are done. The main purpose of the study is to see whether Trimbow works at least as well as Fostair for asthma control.
The study also looks at how often people have worse asthma attacks, how often they need steroid tablets by mouth, and whether breathing and quality of life change during the study. Safety is also watched throughout the treatment period.
1study start
After you join the study, you are assigned to one of two treatment groups in a random way. This means the treatment is chosen by chance, not by choice.
The study is open-label, which means you and the study staff know which inhaler you are using.
2treatment period
You use one inhaler treatment for 12 months.
One possible treatment is Trimbow 87 micrograms/5 micrograms/9 micrograms, which contains beclometasone dipropionate, formoterol fumarate dihydrate, and glycopyrronium bromide. It is taken by inhalation. The stated dose is 400 micrograms per administration.
The other possible treatment is Fostair 200 microgram/6 microgram per actuation, which contains formoterol fumarate dihydrate and beclometasone dipropionate anhydrous. It is taken by inhalation. The stated dose is 800 micrograms per administration.
The study records how your asthma control changes during this 12-month period.
3study visits and assessments
You attend study visits during the treatment period, including a visit at month 12.
At the visits, your asthma control is checked using the Asthma Control Questionnaire-5 (ACQ-5). This is a short questionnaire about how well your asthma is controlled.
Your breathing is measured with spirometry, which is a test that measures how much air you can breathe out and how fast you can breathe it out.
Your breathing may also be measured with oscillometry, which is a test that checks how air moves through your airways.
Blood or other test results may be used to check eosinophils, which are a type of blood cell linked to allergy and asthma.
You complete questionnaires about inhaler use, quality of life, and asthma symptoms, including the Test of the Adherence to Inhalers, the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L), and the chronic airways assessment test.
The study also records whether you have asthma flare-ups, including severe and moderate flare-ups. A flare-up means your asthma gets worse.
The study records whether you need oral systemic corticosteroids. These are steroid medicines taken by mouth to reduce inflammation.
The study also records safety information, including cardiovascular events, which involve the heart or blood vessels, and any serious or fatal events.
4monitoring during the 12-month period
During the 12 months, the study checks how long it takes before your first severe asthma flare-up and your first moderate or severe asthma flare-up.
The study also records the number of days you use oral systemic corticosteroids and the total dose you take during the treatment period.
Your asthma control, breathing test results, and questionnaire answers are compared with your starting results over time.
5month 6 assessment
At 6 months, the study checks your asthma control and other measured results again.
The study looks at whether you meet the definition of partial clinical asthma remission or complete clinical asthma remission at this timepoint.
Complete clinical asthma remission means: no oral steroid use at that time, no severe asthma flare-up before that time, an ACQ-5 score of 1.5 or lower, and no decrease in the breathing test result called forced expiratory volume in 1 second after using the inhaler. This breathing test result shows how much air you can force out in one second.
Partial clinical asthma remission means: no oral steroid use at that time, and two of the other three remission conditions are met.
6month 12 assessment and end of treatment period
At 12 months, you have the final study assessment for the main outcome of the trial.
The main result is the change in ACQ-5 from the start of the study to month 12.
The study again checks asthma flare-ups, breathing test results, questionnaire answers, eosinophils, use of oral systemic corticosteroids, and safety information.
The study also checks whether you meet the definitions of partial clinical asthma remission or complete clinical asthma remission at 12 months.
Who Can Join the Study?
Written informed consent must be given before any study procedure. This means the person must sign a form showing they understand the study and agree to take part.
Adults only: the participant must be a male or female aged 18 years or older.
The participant must have a doctor-confirmed asthma diagnosis, documented according to usual medical practice.
The participant must have had stable asthma treatment for at least 3 months before randomization. Randomization means being assigned to a study treatment by chance.
The participant must have poor asthma control at the time of randomization, shown by an ACQ-5 score of 1.5 or higher and at least 1 asthma exacerbation in the previous year. An exacerbation means a flare-up or worsening of asthma.
Women who can become pregnant and their male partners with fertility must be willing to use a highly effective birth control method from the time the consent form is signed until the last study visit.
The participant must be able to cooperate with the study and be trained to use the patient app correctly.
The participant must be able to complete the required study measurements, including electronic patient-reported outcomes (ePRO), which are answers the patient enters electronically about their health and symptoms.
The participant must be able to understand the risks involved in taking part.
Participants with asthma may still be included if they do not have a clinically relevant diagnosis of chronic obstructive pulmonary disease (COPD), which is a long-term lung disease that makes breathing difficult.
Participants using maintenance and reliever therapy may be included if the daily dose of inhaled corticosteroid (ICS) does not exceed 400 micrograms per day of beclometasone or an equivalent dose. An ICS is a steroid medicine breathed into the lungs to reduce inflammation.
Who Cannot Join the Study?
Taking part in another interventional clinical trial at the same time. An interventional clinical trial is a study where the treatment is actively given or changed.
Being pregnant or breastfeeding at the time of joining the study.
Having another chronic respiratory disease, which means a long-lasting lung or breathing disease, such as lung cancer, alpha1-antitrypsin deficiency (a missing or low protective protein that can harm the lungs), active tuberculosis (a contagious infection that mainly affects the lungs), clinically significant bronchiectasis (permanent widening and damage of the airways that is important enough to affect health), interstitial lung disease (scarring or inflammation in the lung tissue), pulmonary hypertension (high blood pressure in the blood vessels of the lungs), or any other uncontrolled or medically important disease that the study doctor thinks would interfere with the study.
Having a medical reason that makes the use of long-acting muscarinic antagonists unsafe. These are medicines that help keep the airways open for a long time.
Using biological therapy for asthma. Biological therapy means treatment made from living cells or proteins, often given by injection or infusion.
For people in France only: being under court protection, including protected adults, or not being linked to the French social security system.
Trimbow is an inhaled medicine used in the study as the test treatment for asthma. It contains three medicines in one inhaler: a steroid to help reduce swelling and irritation in the airways, a long-acting bronchodilator to help keep the airways open, and another bronchodilator that relaxes the muscles around the airways. The goal is to see whether this single inhaler works at least as well as the comparison treatment for helping people control their asthma.
Fostair is an inhaled medicine used in the study as the comparison treatment for asthma. It contains two medicines in one inhaler: a steroid to reduce inflammation in the airways and a long-acting bronchodilator to help keep the airways open. It is used to compare how well it controls asthma symptoms and how safe it is compared with the test inhaler.
Asthma – Asthma is a long-term disease of the airways that causes them to become swollen and extra sensitive. The airways can narrow and produce more mucus, which leads to repeated episodes of wheezing, shortness of breath, chest tightness, and coughing. Its course often changes over time, with symptom-free periods followed by flare-ups. In some people, the symptoms remain mild, while in others they become more frequent or persistent.
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