Australian Doctor 16th June 2023 16JUNE2023 issue | Page 27

For patients with moderate to very severe COPD

BREZTRI AEROSPHERE ®

PREVENT exacerbations 1 , 2 *

* Reduction in the annual rate of moderate † or severe ‡ exacerbations 24 % vs . GLY / FORM p < 0.0001 and 13 % vs . BUD / FORM p = 0.0027 1 , 2 §

REDUCE the risk of death 1 – 4 # ^

#

49 % Reduction in risk of death ( all-cause ) vs . GLY / FORM ( HR , 0.51 ; 95 % CI , 0.33 – 0.80 ; unadjusted p = 0.0035 ) and 28 % reduction vs . BUD / FORM ( p = 0.1721 ; not statistically significant ) over 52 weeks ; pre-specified secondary endpoint 1 – 4 ¶

ADVANCED pMDI technology 1 , 5 – 7 ¥

¥

AEROSPHERE Inhaler with co-suspension technology depositing consistent dose throughout the lungs 1 , 5 – 7 ** ∫a ** In patients with moderate-to-very severe COPD , 32.1 % lung deposition , including large and small airways , with up to 10-second breath-hold 7^^

A fixed dose ICS / LABA / LAMA combination with advanced pMDI technology 1 , 5 – 7 ¥

^ BREZTRI AEROSPHERE ® is indicated as a maintenance treatment to prevent exacerbations and relieve symptoms in adults with moderate , severe , or very severe COPD who require treatment with a combination of ICS , LABA , and LAMA . 1 BREZTRI AEROSPHERE ® is not indicated for the initiation of therapy in COPD . 1

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SAFETY : In ETHOS , adverse events that occurred in ≥3 % of patients overall for BREZTRI ®, BUD / FORM and GLY / FORM were nasopharyngitis , COPD , upper respiratory tract infection , pneumonia and bronchitis . 2 The incidence of confirmed pneumonia was 4.2 % with BREZTRI ®, 4.5 % with BUD / FORM and 2.3 % with GLY / FORM . 1 , 2 Please review Product Information for information on other Precautions and Adverse Effects . 1

† Moderate exacerbations were defined as events requiring the use of systemic corticosteroids and / or antibiotics for at least 3 days . 1 ‡ Severe exacerbations were defined as events resulting in inpatient COPD-related hospitalisation or COPD-related death . 1 , 2 ¶ Results shown are for the final retrieved data set which includes additional data from 354 patients who had incomplete 1-year vital status at the time of trial completion . The p-value is considered unadjusted due to an endpoint in the Type 1 error control testing hierarchy not reaching significance . 2 – 4 Note : BREZTRI ® 160 / 14.4 / 10 μg BID dose is not registered and therefore the data are not presented . 2 § ETHOS study design : A 52- week phase 3 , randomised , double-blind , parallel-group trial to assess the safety and efficacy of BREZTRI ® at two doses of ICS ( 320 / 14.4 / 10 μg and 160 / 14.4 / 10 μg ) compared with GLY / FORM ( 14.4 / 10 μg ) and BUD / FORM ( 320 / 10 μg ) delivered twice daily via pMDI , in symptomatic patients with moderate to very severe COPD and a history of ≥1 exacerbation in the past year ( n = 8,588 ). The primary endpoint was the annual rate of moderate or severe COPD exacerbations ; 2 ∫Review article design : A narrative review of literature including in-vivo , in-vitro , and patient studies focussing on dose delivery , lung deposition , and airway response using Aerosphere ® inhaler ; 5 aVehring study design : The aim of this in-vitro study was to evaluate the stability , dose delivery , and fine particle fraction of co-suspension of glycopyrrolate , formoterol fumarate dihydrate or mometasone furoate – added individually , in pairs , or all three together – contained in a pressurised metered dose inhaler ; 6 ^^Usmani study design : A phase I , single-dose , open-label gamma scintigraphy imaging study in patients with moderate-to-very severe COPD ( N = 18 ), assessing the lung deposition of BUD / GLY / FORM . One patient ( with moderate COPD ) was excluded due to improper MDI inhalation technique . 7

PBS Information : Authority required ( STREAMLINED ) for the treatment of COPD . Refer to PBS for full authority information .

PLEASE REVIEW FULL PRODUCT INFORMATION BEFORE PRESCRIBING . PRODUCT INFORMATION AVAILABLE ON REQUEST FROM ASTRAZENECA ON 1800 805 342 OR WWW . ASTRAZENECA . COM . AU / PI OR BY SCANNING THIS QR CODE .

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BREZTRI ®

Product Information

BID = twice daily ; BUD = budesonide ; CI = confidence interval ; COPD = chronic obstructive pulmonary disease ; ETHOS = The Efficacy and Safety of Triple Therapy in Obstructive Lung Disease ; FORM = formoterol ; GLY = glycopyrronium ; HR = hazard ratio ; ICS = inhaled corticosteroid ; LABA = long-acting beta 2 agonist ; LAMA = long-acting muscarinic antagonist ; MDI = metered dose inhaler ; pMDI = pressurised Metered Dose Inhaler . References : 1 . BREZTRI AEROSPHERE ® Approved Product Information . 2 . Rabe F et al . N Engl J Med . 2020 ; 383 ( 1 ): 35 – 48 . 3 . Rabe F et al . N Engl J Med . 2020 ; 383 ( 1 ): 35 – 48 . Supplementary appendix . 4 . Martinez FJ et al . Am J Respir Crit Care Med . 2021 ; 203 ( 5 ): 553 – 564 . 5 . Usmani OS et al . Int J Chron Obstruct Pulmon Dis . 2021 ; 16:113 – 124 . 6 . Vehring R et al . Langmuir . 2012 ; 28:15015 – 15023 . 7 . Usmani O et al . Respir Res . 2021 ; 22 ( 1 ): 261 . BREZTRI ® and AEROSPHERE ® are registered trademarks of the AstraZeneca group of companies . Registered user 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 [phone] or via https :// contactazmedical . astrazeneca . com or email Medical Information enquiries to medinfo . australia @ astrazeneca . com . AU-15784 . 001830 . February 2023 .