AstraZeneca Launches Breztri Aerosphere®, A Triple Therapy Treatment For COPD 1  

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Mr Vinod (centre) launching Breztri Aerosphere together with Jenny Poon, Business Unit Director from AstraZeneca (second from left) and members of the medical fraternity
Mr Vinod (centre) launching Breztri Aerosphere together with Jenny Poon, Business Unit Director from AstraZeneca (second from left) and members of the medical fraternity

AstraZeneca Sdn Bhd is an international pharmaceutical company with a presence in Malaysia since 1981. It is among the pharmaceutical companies that focus on the research and development of medicines including in the therapy of respiratory diseases. Together with a group of medical experts in Malaysia, the company held a Panel Discussion to review the burden and needs for COPD care and management in Malaysia. The discussion session also emphasized the importance of COPD management based on the latest data and guidelines, referring to the Global Initiatives for Chronic Obstructive Lung Disease (GOLD) Report 2024.

At the same time, AstraZeneca also launched its latest triple therapy, Breztri Aerosphere® to cater to the unmet needs of patients living with chronic obstructive pulmonary disease (COPD).

COPD is a serious lung condition that causes airways to narrow, become obstructive and inflamed, making breathing difficult. When symptoms worsen, a flare-up can occur. This can lead to bad days for COPD patients, further compromising their quality of life, and can require hospitalisation in more severe cases.8 Managing COPD flare-ups is crucial to avoid any potential damage to a patient’s lungs in the long term and associated cardiovascular events.8

In 2019, COPD affected an estimated 391.9 million people globally 9 and was the 3rd leading cause of death resulting in 3.23 million deaths 10. It is estimated that approximately 70% of patients with COPD may still be undiagnosed.12  

Similarly, in Malaysia, COPD is significantly underdiagnosed13 with total COPD prevalence among adult of 6.5%.14 Respiratory diseases are among the leading causes of hospitalizations and deaths in Malaysia.15 A high re-admission rate of 30% – 40% is also recorded with patients’ hospital stays averaging six days.16,17,18 This puts a burden on the public healthcare system with high direct costs for the management of COPD (USD506.92) and indirect costs due to productivity losses for COPD patients (USD 1699.76).19 

In a study conducted in three tertiary hospitals in Malaysia from January 2018 to December 2022, it was observed that 49.59% of COPD patients experiencing severe exacerbation succumb within about 6 years of diagnosis, highlighting the impact of the disease to the patients.20

Doing the Lung Screening Test

Breztri Aerosphere® is a long-term medicine to treat COPD and give patients better breathing, improve COPD symptoms and reduce COPD flare-ups or attacks (exacerbations) and potential hospitalisation.1  

A triple therapy with three types of medicines (budesonide, glycopyrronium and formoterol fumarate) in one metered dose inhaler, Breztri Aerosphere® comprises ICS (inhaled corticosteroid), LAMA (long-acting muscarinic antagonist) and LABA (long-acting beta2-adrenergic agonist). 1 

Working in tandem, the LAMA and LABA which are bronchodilators, help muscles around the airways in the lungs to stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath while the ICS helps decrease inflammation in the lungs.1 

Vinod Narayanan, AstraZeneca Malaysia Country President, said, “The disease burden for COPD globally gives us a strong reason to lead with the science and move beyond symptom control.

We are committed to continually develop and deliver next generation treatments with the potential to reduce exacerbations, hospitalisations and mortality, including advancing a net zero healthcare strategy for respiratory care. 

“Our latest triple combination therapy, Breztri Aerosphere®, has evidence across several clinical trials demonstrating reduction in flare-ups and COPD related hospitalisations. 3,4,5,6. AstraZeneca’s aim is to reverse the progression of COPD, transform treatment goals and improve patient outcomes,” he added.

Breztri Aerosphere® has been available as a maintenance treatment for adult COPD patients in countries worldwide, including the US, EU, China and Japan.21 It has been approved for use in Malaysia since September 2024.22

Clinical Trials for Breztri Aerosphere® Show Reduction in Flare-Ups

The Phase III ETHOS was a 52-week double-blind trial involving 8,588 patients aged 40-80 years with moderate to very severe COPD and a history of moderate or severe exacerbation(s) in the previous year.3 Breztri Aerosphere’s® triple therapy showed a statistically significant reduction of up to 24% in exacerbations compared with dual-combination therapies.3 It was also observed that Breztri Aerosphere® reduced risk of all-cause mortality by 49% compared with dual-combination therapies.

The Phase III KRONOS was a 24-week trial involving 1,902 patients aged 40-80 years with moderate to very severe COPD, with no requirement of history for moderate or severe exacerbation(s) in the previous year.6  Breztri Aerosphere® was shown to significantly reduce moderate or severe exacerbations compared with dual-combination therapies.6

Results from the Phase III ETHOS trial were published in The New England Journal of Medicine (June 2020)3 and results from the Phase III KRONOS trial were published in The Lancet Respiratory Medicine (September 2018).6

Understanding COPD

COPD symptoms are shortness of breath (dyspnea) while doing every day activities, wheezing (high pitched whistle during breathing), tightness in the chest, cough, fatigue, mucus (sputum) and frequent respiratory infections.23 Often, it is caused by inhaling pollutants from tobacco smoking and secondary smoke, fumes, chemicals, dust in the environment as well as genetics and history of childhood respiratory infections.23

Speaking at the COPD Panel Discussion, Prof Dr Ahmad Izuanuddin Ismail, Consultant Pulmonologist, Deputy Director (Clinical), Universiti Teknologi MARA (UiTM) said, “COPD is a common, preventable and treatable disease24 but it can also be life-threatening, especially if not treated and managed properly.25  

“While COPD can’t be cured, it is important to help improve symptoms and reduce flare-ups.26 Early warning signs of a flare-up include increases in cough, increase or changes in mucus and more shortness of breath with the same or less activity.27  A COPD flare-up can last 2 days or more and varies with each person.27 

“It is equally important to understand that even a single acute flare-up may be associated with a significant increase in the rate of decline in lung function28 and a significant deterioration in quality of life29. Studies have shown that one in five people die within a year of their first hospitalisation.

“The impact of COPD is debilitating on the quality of lives of both patients and their carers. It can restrict a patient’s independence, social interactions as well as professional lives. We cannot underestimate the importance of prevention and disease management,” he emphasised.

In Malaysia, there is generally a limited awareness on COPD and some patients even lack proficiency in using their treatment devices. Also, a challenge unique to Malaysia is the lack of a term for COPD in Malay, leading to a lack of understanding of the disease and appropriate treatments.

For more information on COPD, log on to https://mysihatpal.com.my

  1. https://quest3plus.bpfk.gov.my/front- end/attachment/668/pharma/558456/ 

558456_20240313_145903_.pdf 

3. Rabe KF, et al. Inhaled Triple Therapy at Two Glucocorticoid Do in

Moderate-to-Very Severe COPD. N Engl J Med. 2020; 383: 35-48.

  1. Martinez FJ, et al. Reduced all-cause mortality in the ETHOS trial of 

budesonide/glycopyrrolate/formoterol for chronic obstructive 

pulmonary disease. A randomized, double-blind, multicenter, parallel-

group study. Am J Respir Crit Care Med. 2021; 203: 553-564.

  1. Müllerová H, et al. Association of COPD exacerbations and acute 

cardiovascular events: a systematic review and meta-analysis. Ther Adv 

Respir Dis. 2022, Vol 16: 1-11.

  1. Ferguson GT, Rabe KF, Martinez FJ, et al. Triple combination of 

budesonide/glycopyrrolate/formoterol fumarate using co-suspension 

delivery technology versus dual therapies in chronic obstructive 

pulmonary disease (KRONOS): a double-blind, parallel-group, 

randomised controlled trial. Lancet Respir Med. 2018; 6: 747–758.

  1. Khan KS, Jawaid S, Memon UA, Perera T, Khan U, Farwa UE, Jindal U, Afzal 

MS, Razzaq W, Abdin ZU, Khawaja UA. Management of Chronic 

Obstructive Pulmonary Disease (COPD) Exacerbations in 

Hospitalized Patients From Admission to Discharge: A Comprehensive 

Review of Therapeutic Interventions. Cureus. 2023 Aug 

18;15(8):e43694. doi: 10.7759/cureus.43694. PMID: 37724212; PMCID

PMC10505355.

  1. Adeloye D, Song P, Zhu Y, Campbell H, Sheikh A, Rudan I; NIHR RESPIRE 

Global Respiratory Health Unit. Global, regional, and national prevalence 

of, and risk factors for, chronic obstructive pulmonary disease (COPD) in 

2019: a systematic review and modelling analysis. Lancet Respir Med. 

2022 May;10(5):447-458. doi: 10.1016/S2213-2600(21)00511-7. Epub 

2022 Mar 10. PMID: 35279265; PMCID: PMC9050565.

  1. World Health Organization. The top 10 causes of death. 24 May 2018. 

Available at: https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death

Diab N, Gershon AS, Sin DD, Tan WC, Bourbeau J, Boulet LP, Aaron SD. 

11. Underdiagnosis and Overdiagnosis of Chronic Obstructive Pulmonary 

Disease. Am J Respir Crit Care Med. 2018 Nov 1;198(9):1130-1139. doi: 

10.1164/rccm.201804-0621CI. PMID: 29979608.

13. https://www.e-mfp.org/old/2010v5n3/pdf/chronic_obstructive_pulmonary_disease.pdf

14. Loh, L.C et al 2016. Respirology 21(6): 1055-61

15. https://journalarticle.ukm.my/20013/1/Paper_6_NORIZA.pdf

16. Abas et al. International Medical Journal Vol. 27, No. 6, pp. 705 – 708

December 2020 

17. Aqqad et al. Clin Respir J. 2017 Nov;11(6):960-967

18. Loh LC et al. 2016. DOI: 10.21767/2572-5548.100004

19. Ur Rehman A, Hassali MAA, Muhammad SA, Shakeel S, Chin OS, Ali 

IABH, Muneswarao J, Hussain R. Economic Burden of Chronic Obstructive Pulmonary Disease Patients in Malaysia: A Longitudinal Study. Pharmacoecon Open. 2021 Mar;5(1):35-44. doi: 10.1007/s41669-020-00214-x. PMID:32291727; PMCID: PMC7895885.

20.        S. S. Sirol Aflah, A. I. Ismail, W. Chee Kuan, A. N. Musa. The Survival Rate 

of COPD Patients in Malaysia : EXACOS-MY study. COPD – exacerbations, 

Exacerbation, Bronchodilators 

21. Heo YA. Budesonide/Glycopyrronium/Formoterol: A Review in COPD. 

Drugs. 2021 Aug;81(12):1411-1422. doi: 10.1007/s40265-021-01562-6. 

Epub 2021 Aug 3. Erratum in: Drugs. 2021 Sep;81(14):1699. doi: 

10.1007/s40265-021-01595-x. PMID: 34342835; PMCID: PMC8384783.

22. Breztri DCA Approval.pdf 

23. https://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd)

24. https://ncbi.nlm.nih.gov/books/NBK559281

25. https://www.nhs.uk/conditions/chronic-obstructive-pulmonary-disease-copd/

26. Global Allergy & Airways Patient Platform. Available at: https://gaapp.org/copd/what-is-copd/. [Last accessed: January 2023]

27. https://www.lung.org/lung-health-diseases/lung-disease-lookup/copd/living-with-copd/prevent-flare-ups

28. Halpin DMG, et al. Effect of a single exacerbation on decline in lung 

function in COPD. Respiratory Medicine 2017; 128: 85-91.

29. Roche N, et al. COPD exacerbations significantly impact quality of life as 

measured by SGRQ-C total score: results from the FLAME study. Eur Resp 

J. 2017; 50 (Suppl 61): OA1487

30. Ho TW, et al. In-Hospital and One-Year Mortality and Their Predictors in 

Patients Hospitalized for First-Ever Chronic Obstructive Pulmonary Disease 

Exacerbations: A Nationwide Population-Based Study. PLOS ONE. 2014; 9 

(12): e114866.

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