A post-hoc analysis of the Phase III ETHOS trial showed a consistent benefit of Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) in reducing the rate of moderate or severe chronic obstructive pulmonary disease (COPD) exacerbations across all seasons compared with Bevespi Aerosphere (glycopyrronium/formoterol fumarate) in patients with moderate to very severe disease.[1]

These data are among 60 AstraZeneca abstracts accepted for presentation, including 10 oral presentations, at the European Respiratory Society (ERS) International Virtual Congress 2020, between 7-9 September.

Gary Ferguson, Clinical Professor of Medicine at Michigan State University, Director of the Pulmonary Research Institute of Southeast Michigan, Farmington Hills, Michigan, US and Investigator in the ETHOS trial, said: "Treating patients with chronic obstructive pulmonary disease can be challenging in the winter as they experience more frequent and more severe exacerbations, contributing to increased morbidity and mortality. Results from the ETHOS trial should give clinicians confidence that they can reduce moderate or severe exacerbations, even during winter when respiratory diseases can put additional strain on healthcare systems."

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, said: "These additional data from the Phase III ETHOS trial are important in supporting clinicians' understanding of the robust clinical profile of Breztri Aerosphere, which has been approved in the US, China and Japan and is under regulatory review in the EU. With 60 company abstracts accepted for presentation at ERS, there is a wealth of data across AstraZeneca's inhaled combinations and biologic medicines, which demonstrates our commitment to advancing clinical practice in respiratory disease."

AstraZeneca abstracts to be presented at the ERS International Congress 2020 include:

• Seasonal variation in COPD exacerbation rates:

• Exacerbation benefit by blood eosinophil counts with budesonide/glycopyrronium/formoterol metered dose inhaler (BGF MDI) at two ICS dose levels in the ETHOS trial: a subgroup analysis (E-poster session: Abstract PA984, Monday 24 August)

• LATE BREAKER: Reimbursement for asthma care is a universal barrier to achieving asthma symptom control: The SABINA III study (E-poster session: Abstract PA2665, Monday 24 August)

• LATE BREAKER: Short-Acting β2-Agonist Use in Asthma in Western Societies (E-poster session: Abstract PA2629, Monday 24 August)

• Efficacy of as-needed budesonide/formoterol in mild asthma: pooled analysis of SYGMA 1 and 2 (E-poster session: Abstract PA2275, Monday 24 August)

• Real-world treatment patterns of benralizumab therapy for patients with severe asthma. (Oral presentation: Abstract OA4646, Tuesday 08 September 15:40-16:40 CEST)

• LATE BREAKER: Benralizumab in severe asthma: preliminary results from the Italian ANANKE study (E-poster session: Abstract PA2609, Monday 24 August)

• Efficacy of tezepelumab in patients with low and high bronchodilator reversibility in PATHWAY (E-poster session: Abstract PA2269, Monday 24 August)

• Profiling the impact of two JAK inhibitors (AZD0449 & AZD4604) in a pre-clinical model of allergic asthma (E-poster session: Abstract PA3302, Monday 24 August)

COPD

COPD is a progressive disease which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness.[2 ]It affects an estimated 384 million people[3] and is the third leading cause of death globally.[4] Improving lung function, reducing exacerbations and managing daily symptoms such as breathlessness are important treatment goals in the management of COPD.[2] A single COPD exacerbation can have a negative impact on lung function[5], quality of life[6] and increase the risk of hospitalisation.[7] Additionally, even one COPD exacerbation that results in hospitalisation, increases the risk of death.[8,9]

Patients with COPD experience an increase in incidence of exacerbations and severe exacerbations during the winter.[10,11] Studies have also shown higher rates of COPD hospital admissions and more respiratory-related deaths in winter compared with summer months.[10-13 ]

ETHOS

ETHOS is a randomised, double-blind, multi-centre, parallel-group, 52-week trial to assess the efficacy and safety of Breztri Aerosphere in symptomatic patients with moderate to very severe COPD and a history of exacerbation(s) in the previous year. The primary endpoint was the rate of moderate or severe exacerbations. Results were published in the New England Journal of Medicine (https://www.nejm.org/doi/full/10.1056/NEJMoa1916046).[14]

Breztri Aerosphere

Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) is a single-inhaler, fixed dose triple-combination of budesonide, an inhaled corticosteroid (ICS), with glycopyrrolate, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta2-agonist (LABA), delivered in a pressurised metered-dose inhaler.

AstraZeneca in Respiratory & Immunology 

Respiratory & Immunology is one of AstraZeneca's three therapy areas and is a key growth driver for the Company.

Building on a 50-year heritage, AstraZeneca is an established leader in respiratory care, across inhaled and biologic medicines. AstraZeneca aims to transform the treatment of asthma and COPD by eliminating preventable asthma attacks across all severities and removing COPD as a leading cause of death through earlier biology-led treatment. The Company's early respiratory research is focused on emerging science involving immune mechanisms, lung damage and abnormal cell-repair processes in disease and neuronal dysfunction.

With common pathways and underlying disease drivers across respiratory and immunology, AstraZeneca is following the science from chronic lung diseases to immunology-driven disease areas. The Company's growing presence in immunology is focused on five mid- to late-stage franchises with multi-disease potential in rheumatology (including systemic lupus erythematosus), dermatology, gastroenterology, and systemic eosinophilic-driven diseases. AstraZeneca's ambition in immunology is to achieve disease control and ultimately clinical remission in targeted immune-driven diseases.

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 and Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com (http://www.astrazeneca.com/) and follow the Company on Twitter @AstraZeneca (https://twitter.com/AstraZeneca).

Contacts

For details on how to contact the Investor Relations Team, please click here (https://www.astrazeneca.com/investor-relations.html#Contacts). For Media contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html).
 

References

1. Ferguson GT, Rabe KF, Martinez FJ, et al. Seasonal variation in COPD exacerbation rates: budesonide/glycopyrronium/formoterol metered dose inhaler (BGF MDI) at two ICS dose levels in the ETHOS trial. Abstract OA5238 [Oral Presentation]. Presented at the European Respiratory Society International Virtual Congress 2020 (7th-9th September).  
2. GOLD. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2020. [Online]. Available at: http://goldcopd.org. [Last accessed: September 2020].
3. Adeloye D, Chua S, Lee C, et al. Global Health Epidemiology Reference Group (GHERG). Global and regional estimates of COPD prevalence: Systematic review and meta-analysis. J Glob Health. 2015; 5 (2): 020415.
4. Quaderi SA, Hurst JR. The unmet global burden of COPD. Glob Health Epidemiol Genom. 2018; 3: e4. Published 2018 Apr 6. doi:10.1017/gheg.2018.1.
5. Halpin DMG, Decramer M, Celli BR, et al. Effect of a single exacerbation on decline in lung function in COPD. Respiratory Medicine 2017; 128: 85-91.
6. Roche N, Wedzicha JA, Patalano F, 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.
7. Rothnie KJ, Müllerová H, Smeeth L, Quint JK. Natural History of Chronic Obstructive Pulmonary Disease Exacerbations in a General Practice-based Population with Chronic Obstructive Pulmonary Disease. Am Jour of Resp Crit Care Med. 2018; 198 (4): 464-471. 
8. Ho TW, Tsai YJ, Ruan SY, 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.
9. Suissa S, Dell'Aniello S, Ernst P. Long-term natural history of chronic obstructive pulmonary disease: severe exacerbations and mortality. Thorax. 2012; 67 (11): 957-63.
10. Jenkins CR, Celli B, Anderson JA, et al.  Seasonality and determinants of moderate and severe COPD exacerbations in the TORCH study. Eur Respir J 2012; 39: 38-45.
11. Wise RA, Calverley PMA, Carter K et al. Seasonal variations in exacerbations and deaths in patients with COPD during the TIOSPIR trial. Int J Chron Obstruct Pulmon Dis. 2018;13:605-616.
12. Donaldson GC, Wedzicha JA. The causes and consequences of seasonal variation in COPD exacerbations. Int J Chron Obstruct Pulmon Dis. 2014; 9: 1101-1110.
13. Chakraborti A, Ramanathan R. Alunilkummannil J. Seasonal variations in outcomes and costs for COPD. Chest 2019; 156 (4) Suppl: A1164.
14. Rabe KF, Martinez FJ, Ferguson GT, et al. Inhaled Triple Therapy at Two Glucocorticoid Doses in Moderate-to-Very Severe COPD. N Engl J Med 2020; 383:35-48.