BREZTRI AEROSPHERE® 160/7.2/5 (budesonide/glycopyrronium/formoterol) with a Next Generation Propellant,1 offering a 99.9% reduction in global warming potential (GWP) compared to the previous propellant2 is now registered by the Australian Therapeutic Goods Administration (TGA) for use in Australia and is available for Australians on the Pharmaceutical Benefits Scheme (PBS).
BREZTRI AEROSPHERE® is a fixed-dose triple-combination pressurised metered dose inhaler (pMDI), registered and PBS reimbursed for adults with moderate, severe, or very severe chronic obstructive pulmonary disease (COPD)1. It is the first respiratory pMDI using a Next Generation Propellant with near-zero global warming potential2 to receive TGA registration in Australia3.
- Inhaled respiratory medicines delivered by pressurised metered dose inhalers (pMDIs) are essential for millions of Australians living with respiratory disease and are the most used medicines in respiratory care.4,5,
- COPD is a lung disease characterised by chronic obstruction of lung airflow that interferes with normal breathing and is not fully reversible. Symptoms of COPD include cough, sputum production, and difficult or laboured breathing. Symptoms often don't appear until significant lung damage has occurred, which usually worsens over time.6
- Around 496,000 (4.8%) people aged 45 and over in Australia were estimated to be living with COPD in 2022. In 2023-24 there were 67,700 hospitalisations with a principal diagnosis of COPD for people 45 and over. In 2023 COPD was the underlying cause of 7,437 deaths6.
Dr Marie Guillet, Country President of AstraZeneca Australia and New Zealand, welcomed the TGA registration.
“The registration of BREZTRI AEROSPHERE® Next Generation Propellant in Australia means that healthcare professionals can continue to focus on optimising patient care whilst supporting the environment,” Ms Guillet said.
“The new BREZTRI AEROSPHERE® Next Generation Propellant will be available in Australia in the coming weeks.
“AstraZeneca is decarbonising its operations and value chain, and investing in reducing GHG emissions across the research, development, manufacture and supply of medicines.”7
The TGA registration follows approval in the United Kingdom and the European Union in 20258,9
Professor Christine Jenkins AM, Program Head, Respiratory at The George Institute for Global Health, a clinician, researcher and international leader in respiratory medicine said:
“New technology in respiratory pMDIs enables clinical decisions to focus on patient need and health outcomes, while also supporting the environment,” Professor Jenkins said.
"The transition to next-generation, low global warming potential propellant inhalers represents a meaningful innovation that maintains the standard of care patients depend on, while significantly reducing the environmental footprint of treatment.
“Optimising clinical outcomes and environmental stewardship are not competing priorities but complementary goals in modern respiratory medicine.”
Mark Brooke, CEO of Lung Foundation Australia said:
“Lung Foundation Australia welcomes innovation that supports both people living with COPD and the health of our planet”, Mr Brooke said.
“The transition to a next-generation propellant in BREZTRI AEROSPHERE® demonstrates how advances in respiratory care can help reduce environmental impact while continuing to support effective treatment.
“Ultimately, the most valuable inhaler is one that people can use correctly and consistently as part of their overall treatment plan, helping to support better outcomes for those living with COPD.”
ABOUT BREZTRI AEROSPHERE®10
Indication:
BREZTRI AEROSPHERE® is used to treat chronic obstructive pulmonary disease (COPD), a serious long-term lung disease that slowly gets worse. COPD can cause difficulty in breathing (breathlessness, wheezing or chest tightening/discomfort), constant coughing and coughing up of mucus (phlegm/sputum). BREZTRI AEROSPHERE® contains three active ingredients:
budesonide – an inhaled corticosteroid which works by reducing and preventing inflammation in your lungs, glycopyrronium – a long-acting muscarinic antagonist (or LAMA) and formoterol – a fast and long-acting beta-2-agonist (or LABA).
Precautions:
Patients should inform their doctor if they have: allergies to any other medicines or foods; have any other medical conditions such as asthma, high blood pressure (hypertension) or heart problems, thyroid problems (thyrotoxicosis), low potassium in your blood (hypokalaemia), diabetes or high blood glucose (hyperglycaemia), prostate problems, problems passing urine, eye problems (glaucoma), severe kidney or liver problems; or take any medicines for any other condition. BREZTRI AEROSPHERE is not recommended for use in children or adolescents under 18 years of age. Check with your doctor if you are pregnant or intend to become pregnant. Talk to your doctor if you are breastfeeding or intend to breastfeed.
Interactions:
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Side effects:
Less serious side effects include headache; painful and/or frequent urination; muscle cramps/spasms; thrush in your mouth; feeling anxious; problems sleeping (insomnia); cough and/or hoarse voice. Serious side effects include: any side effects affecting your chest or heart such as chest pain or a fast, irregular or skipping /fluttering heartbeat; fever or chills, increased phlegm/sputum production or a change in colour, increased cough or difficulties breathing; chest tightness, coughing, wheezing or breathlessness immediately after inhalation; signs and symptoms of an allergic reactions such as shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, rash, itching or hives on the skin.
More information can be found in the BREZTRI AEROSPHERE® Consumer Medicine Information here: BREZTRI AEROSPHERE Consumer Medicine Information
PBS Information11: Authority Required (STREAMLINED) for the treatment of COPD. Refer to PBS for full Authority Required information.
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- ENDS-
Prof Christine Jenkins AM has been involved in initiatives sponsored by AstraZeneca; and has served on advisory boards for which compensation and travel was received. In relation to this media announcement, no compensation was provided to Prof Jenkins and the opinions expressed are her own. Prof Jenkins has been briefed by AstraZeneca on the approved use of this product.
Notes to editors
Global warming potential is a measure of how much gas traps heat in the atmosphere over a 100-year time horizon, relative to carbon dioxide (CO2) with CO2 having a GWP of 1.
Source: United States Environmental Protection Agency. Understanding Global Warming Potentials. Available at: https://www.epa.gov/ghgemissions/ understanding-global-warming-potentials. Accessed July 2026
Media Contacts
AstraZeneca Australia
BREZTRI AEROSPHERE® is a trademark of AstraZeneca. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. www.astrazeneca.com.au.
For Medical Information enquiries or to report an adverse event or product quality complaint: Telephone 1800 805 342 or via https://contactazmedical.astrazeneca.com or email Medical Information enquiries to medinfo.australia@astrazeneca.com
About AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology; Cardiovascular, Renal & Metabolism; and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in more than 100 countries, and its innovative medicines are used by millions of patients worldwide.
For more information, please visit www.astrazeneca.com.au
References
- BREZTRI AEROSPHERE® 160/7.2/5 (budesonide/glycopyrronium/formoterol fumarate dihydrate) pressurised metered dose inhaler, Product Information BREZTRI AEROSPHERE Product Information Accessed July 2026
- United States Environmental Protection Agency. Technology Transitions GWP Reference Table. https://www.epa.gov/climate-hfcs-reduction/technology-transitions-gwp-reference-table Accessed June 2026
- Australian Register of Therapeutic Goods https://www.tga.gov.au/resources/artg Accessed July 2026
- Bell J.P et al. An Assessment of Pressurized Metered-dose Inhaler Use in Countries in Europe and the Rest of the World, American Journal of Respiratory and Critical Care Medicine, Volume 207, Issue Supplement_1, May 2023, Page A6315, https://doi.org/10.1164/ajrccm-conference.2023.207.1_MeetingAbstracts.A6315 Accessed July 2026
- Tewari SG et al. Pressurized metered-dose inhalers using next-generation propellant HFO-1234ze(E) deposit negligible amounts of trifluoracetic acid in the environment. Frontiers in Environmental Science. 11:1297920 doi: 10.3389/fenvs.2023.1297920. https://www.frontiersin.org/journals/environmental-science/articles/10.3389/fenvs.2023.1297920/full, accessed July 2026
- Australian Institute of Health and Welfare. Chronic Respiratory Conditions: Chronic Obstructive Pulmonary Disease https://www.aihw.gov.au/reports/chronic-respiratory-conditions/copd. Accessed July 2026
- AstraZeneca PLC, 'Our Sustainability Impact: Building a healthy future for people, society and the planet” April 2026, accessed July 2026 https://www.astrazeneca.com/sustainability/resources/our-impact.html
- Medicines and Healthcare Regulatory Agency (MHRA), Media Release, 12 May 2025, ‘MHRA approves world’s first low-carbon version of COPD inhaler Trixeo Aerosphere’, https://www.gov.uk/government/news/mhra-approves-worlds-first-low-carbon-version-of-copd-inhaler-trixeo-aerosphere accessed July 2026
- European Medicines Agency (EMA), Media Release, 25 July 2025, ‘First reformulation of an inhaled medicine with environmentally friendly gas propellant”, https://www.ema.europa.eu/en/news/first-reformulation-inhaled-medicine-environmentally-friendly-gas-propellant accessed July 2026
- BREZTRI AEROSPHERE® Consumer Medicine Information (CMI) BREZTRI AEROSPHERE Consumer Medicine Information Accessed July 2026
- The Pharmaceutical Benefits Scheme https://www.pbs.gov.au/medicine/item/12672Y-14536C Accessed July 2026
AstraZeneca Pty. Ltd. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. www.astrazeneca.com.au
For Medical Information enquiries or to report an adverse event or product quality complaint: Telephone 1800 805 342 or via https://contactazmedical.astrazeneca.com | AU-24753