Trixeo Aerosphere
Authorised
This medicine is authorised for use in the European Union
formoterol / glycopyrronium bromide / budesonide
MedicineHumanAuthorised
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Trixeo Aerosphere is a medicine used to treat patients with chronic obstructive pulmonary disease (COPD) and asthma.
COPD is a long-term disease in which the airways and air sacs in the lungs become damaged or blocked, leading to difficulty breathing. Trixeo Aerosphere is used for maintenance (regular) treatment in adults with moderate to severe COPD whose disease is not controlled well enough with a combination of inhaled medicines consisting of a long-acting beta-2 agonist plus either a corticosteroid or a long-acting muscarinic antagonist.
Trixeo Aerosphere is also used in patients aged 12 years and older to treat asthma that is not controlled well enough by inhaled medicines combining corticosteroids and a long-acting beta-2 agonist.
Trixeo Aerosphere contains the active substances formoterol, glycopyrronium bromide and budesonide.
Trixeo Aerosphere can only be obtained with a prescription. It is available as a portable inhaler device. The recommended dose is two inhalations twice a day (two in the morning and two in the evening). Patients should be shown how to use the inhaler correctly by a doctor or other healthcare professional.
For more information about using Trixeo Aerosphere, see the package leaflet or contact your doctor or pharmacist.
Trixeo Aerosphere contains three active substances, which work in different ways to widen the airways and improve breathing in COPD and asthma.
Formoterol is a long-acting beta-2 agonist. It attaches to receptors (targets) known as beta-2 receptors in the muscles of the airways. When it attaches to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient’s breathing.
Glycopyrronium bromide is a long-acting muscarinic receptor antagonist. This means that it blocks muscarinic receptors in muscle cells in the airways. Because these receptors help control the contraction of muscles, glycopyrronium causes the muscles of the airways to relax, helping to keep the airways open.
Budesonide belongs to a group of anti-inflammatory medicines known as corticosteroids. It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system (the body’s natural defences) by attaching to receptors in various types of immune cell. This reduces the release of substances that are involved in the inflammation process, such as histamine, thereby keeping the airways clear and making it easier for the patient to breathe.
COPD
Two main studies involving over 10,000 patients with moderate to very severe COPD have shown that Trixeo Aerosphere is effective at improving patients’ FEV1 (the maximum volume of air they can breathe out in one second) and at reducing the number of exacerbations (flare-ups) of the disease.
In the first study, patients treated with Trixeo Aerosphere for 24 weeks had FEV1 increases of around 147 ml, compared with 125 ml for patients treated with glycopyrronium and formoterol, and 73 ml and 88 ml for patients treated with two different inhalers containing budesonide and formoterol.
The second study, which lasted one year, showed that patients treated with Trixeo Aerosphere had fewer COPD exacerbations per year (1.08) than patients treated with glycopyrronium and formoterol (1.42) or budesonide and formoterol (1.24).
Asthma
Trixeo Aerosphere was investigated in two main studies involving more than 4,000 patients with asthma that was not controlled well enough by treatment combining inhaled corticosteroids and a long-acting beta-2 agonist. The studies showed that Trixeo Aerosphere improved patients’ breathing and reduced the number of asthma flare ups.
In the first study, after 24 weeks of treatment, FEV1 was 56 ml higher on average in patients given Trixeo Aerosphere than in those given budesonide and formoterol. In the second study, FEV1 was 97 ml higher on average with Trixeo Aerosphere than with budesonide and formoterol. Looking at results from both studies together, severe asthma flare-ups occurred around 15% less often in patients treated with Trixeo Aerosphere than in those treated with budesonide and formoterol.
Studies carried out with Trixeo Aerosphere are described in more detail in the medicine’s assessment reports.
For the full list of side effects and restrictions of Trixeo Aerosphere, see the package leaflet.
When used to treat COPD, the most common side effects with Trixeo Aerosphere (which may affect up to 1 in 10 people) include pneumonia (lung infection), headache, oral candidiasis (thrush, a fungal infection) and urinary tract infection (infection of the parts of the body that collect and pass out urine).
When used to treat asthma, the most common side effects (which may affect up to 1 in 10 people) include headache, dysphonia (changes in the sound or tone of the voice) and urinary tract infection.
For the full list of side effects and restrictions of Trixeo Aerosphere, see the package leaflet.
Trixeo Aerosphere improved lung function and reduced disease flare ups in adults with moderate to severe COPD and people aged 12 years and older with asthma which was not controlled well enough by standard treatments.
The safety profile of Trixeo Aerosphere is similar to that of medicines containing combinations of a corticosteroid, beta-2 agonist and an antimuscarinic medicine.
The European Medicines Agency therefore decided that Trixeo Aerosphere’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Trixeo Aerosphere have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Trixeo Aerosphere are continuously monitored. Suspected side effects reported with Trixeo Aerosphere are carefully evaluated and any necessary action taken to protect patients.
Trixeo Aerosphere received a marketing authorisation valid throughout the EU on 09 December 2020.
Product information
Latest procedure affecting product information:X/0000287664
18/09/2025
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Trixeo Aerosphere
- Active substance
- formoterol fumarate dihydrate
- glycopyrronium bromide
- budesonide
- International non-proprietary name (INN) or common name
- formoterol
- glycopyrronium bromide
- budesonide
- Therapeutic area (MeSH)
- Pulmonary Disease, Chronic Obstructive
- Anatomical therapeutic chemical (ATC) code
- R03AL11
Pharmacotherapeutic group
Drugs for obstructive airway diseasesTherapeutic indication
Trixeo Aerosphere is indicated as a maintenance treatment of asthma in patients 12 years of age and older who are not adequately controlled by a combination of a medium dose inhaled corticosteroid and a long-acting beta2-agonist.
Trixeo Aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long acting beta2 agonist or combination of a long-acting beta2 agonist and a long acting muscarinic antagonist.
News on Trixeo Aerosphere
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