Information intended for healthcare professionals only.
This prescribing summary card was developed from content provided by AstraZeneca Limited in a format developed by Guidelines. AstraZeneca Limited commissioned the development of the prescribing card and carried out full medical approval to ensure compliance with regulations.
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AstraZeneca by visiting www.aereporting.astrazeneca.com or by calling 0800 783 0033.
- 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 (ICS) and a long-acting beta2‑agonist (LABA) or combination of a LABA and a long-acting muscarinic antagonist (LAMA).
- The recommended and maximum dose is two inhalations twice daily (two inhalations in the morning, and two in the evening)
- If a dose is missed, it should be taken as soon as possible and the next dose should be taken at the usual time; a double dose should not be taken to make up for a forgotten dose.
- Trixeo Aerosphere is a pressurised metered dose inhaler (pMDI) that combines three agents in one device:
- budesonide (ICS)
- glycopyrronium (LAMA)
- formoterol fumarate (LABA)
- Trixeo’s innovative Aerosphere technology enables 38% to 41% deposition2
- The patient should be shown how to use the inhaler correctly by a healthcare professional and inhalation technique should be checked regularly
- Patients who find it difficult to coordinate actuation with inhalation may use Trixeo Aerosphere with a spacer to ensure proper administration of the medicinal product.
Stepping up from dual to triple therapy3
- NICE recommends offering a LAMA+LABA+ICS for people with COPD who are taking LABA+ICS if:
- their day-to-day symptoms continue to adversely impact their quality of life
- or they have a severe exacerbation (requiring hospitalisation)
- or they have two moderate exacerbations within a year
- NICE recommends considering a LAMA+LABA+ICS for people with COPD who are taking LAMA+LABA if:
- they have a severe exacerbation (requiring hospitalisation)
- or they have two moderate exacerbations within a year
- NICE recommends offering a 3-month trial of triple therapy for people with COPD who are taking LAMA+LABA and whose day-to-day symptoms adversely impact their quality of life. After 3 months, if symptoms have not improved, switch back to LAMA+LABA. If symptoms have improved, continue with LAMA+LABA+ICS.
- NICE recommends minimising the number of inhalers and the number of different types of inhaler used by the patient, as far as possible3
- NICE recommends specifying the brand and inhaler in the prescription to ensure patients receive inhalers they have been trained to use.
- Patients with frequent exacerbations have a risk of death 4.3 times greater than patients with no exacerbations4*
- Trixeo Aerosphere protects against moderate and severe exacerbations5
- Trixeo Aerosphere reduces symptoms of COPD and improves quality of life vs formoterol/glycopyrronium MDI (p<0.0001) and formoterol/budesonide MDI** (p<0.0001).6,7
*In the 52-week ETHOS study (n=8588), Trixeo Aerosphere met the primary endpoint and significantly reduced the annual rate of on-treatment moderate/severe exacerbations by 24% (95% CI: 17, 31; p<0.0001) compared with FOR/GLY MDI (rate; 1.08 vs 1.42 events per patient year) and by 13% (95% CI: 5, 21; p=0.0027) compared with FOR/BUD MDI (rate; 1.08 vs 1.24 events per patient year).
**This regimen is not licensed in the UK.
- Trixeo Aerosphere’s safety profile is consistent with the well-established profiles of its components1,5,8
- The most commonly reported adverse reactions in patients were pneumonia (4.6%), headache (2.7%), and urinary tract infection (2.7%).1
- Trixeo Aerosphere 5 micrograms/7.2 micrograms/160 micrograms pressurised inhalation, suspension – summary of product characteristics. www.medicines.org.uk/emc/product/12028/smpc (Accessed June 2022)
- van den Berge et al. Functional respiratory imaging assessment of budesonide/glycopyrrolate/formoterol fumarate and glycopyrrolate/formoterol fumarate metered dose inhalers in patients with COPD: the value of inhaled corticosteroids. Respir Res 2021; 22: 191.
- NICE. Chronic obstructive pulmonary disease in over 16s: diagnosis and management. Guideline 115. NICE, 2018. Last updated July 2019. www.nice.org.uk/ng115 (Accessed June 2022)
- Soler-Cataluna JJ et al. Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Thorax 2005; 60: 925–931.
- Rabe KF et al. Triple inhaled therapy at two glucocorticoid doses in moderate-to-very severe COPD. N Engl J Med 2020; 383: 35–48.
- Martinez FJ et al. Benefits of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI) on symptoms and quality of life in patients with chronic obstructive pulmonary disease (COPD) in the ETHOS Trial. Am J Respir Crit Care Med 2020; 201: A5073.
- Rabe KF et al. Triple inhaled therapy at two glucocorticoid doses in moderate-to-very severe COPD. N Engl J Med 2020; 383: 35–48. (Supplementary Appendix).
- Ferguson GT et al. Triple therapy with budesonide/glycopyrrolate/formoterol fumarate with co-suspension delivery technology versus dual therapies in chronic obstructive pulmonary disease (KRONOS): a double-blind, parallel-group, multicentre, phase 3 randomised controlled trial. Lancet Respir Med 2018; 6 (10):747–758.
Date of preparation: July 2022