PBS
LISTED 1
Give your COPD patients relief from exacerbations with Trimbow ® 2-4 *
* Triple therapy with Trimbow ® significantly reduced moderate-severe exacerbations vs LABA / LAMA ( IND / G ; p = 0.043 )† and vs ICS / LABA ( BDP / FF ; p = 0.005 ) 2 , 3 ‡ TWO PUFFS TWICE DAILY
Australia ’ s first extrafine § fixed-dose triple therapy for COPD in a pMDI 4
§
Mass median aerodynamic diameter ( MMAD ) particle size < 2 μm
Alleviating night-time & day-time symptoms 4
Trimbow ® is indicated for maintenance treatment in adult patients with moderate-to-severe COPD . Trimbow ® is not to be used as initial therapy , but may be considered as step-up from ICS / LABA or LABA / LAMA , or as switch from ICS + LABA + LAMA ( triple therapy ). 4
PBS Information : Authority Required ( STREAMLINED ). Chronic Obstructive Pulmonary Disease . Criteria Apply . Refer to PBS Schedule for full information .
Before prescribing , please review the Product Information available in the primary advertisement in this publication .
† Study Design : A double-blind , randomised , double-dummy , parallel-group , multicentre , multinational trial conducted across 17 countries and over 52 weeks . Eligible adult ( ≥40 years ) COPD patients had an FEV 1
< 50 % and at least one documented moderate-severe exacerbation in the previous year . Patients ( n = 1532 ) were randomised to treatment with extrafine BDP / FF / G 100 / 6 / 10 μg via pMDI ( Trimbow ®, 2 puffs twice daily ) or IND / G 110 / 50 μg via DPI ( Ultibro ® Breezhaler ®; 1 inhalation once daily ). Primary endpoint was the rate of moderate-severe COPD exacerbations across 52 weeks . COPD exacerbations were defined as sustained worsening of respiratory symptoms that required treatment with systemic corticosteroids , antibiotics , or hospital admission . 2
‡
Study Design : A double-blind , randomised , multinational , multicentre , active-controlled study conducted over 52 weeks . Eligible adult ( ≥40 years ) COPD patients had an FEV₁ < 50 % and at least one documented moderate-severe exacerbation in the previous year . Patients ( n = 1368 ) were randomised to receive either extrafine BDP / FF / G 100 / 6 / 10 μg via pMDI ( Trimbow ®; 2 puffs twice daily ) or extrafine BDP / FF 100 / 6 μg via pMDI ( Fostair ®; 2 puffs twice daily ). Co-primary endpoints were change in lung function from baseline ( pre-dose morning FEV₁ at week 26 and 2-hour post-dose FEV₁ at week 26 ) and breathlessness ( TDI focal score at week 26 ). No statistically significant difference was observed in the TDI focal score between both treatments at week 26 ( co-primary endpoint ). 3
Abbreviations : COPD , Chronic obstructive pulmonary disease ; BDP , Beclometasone ; DPI , Dry powder inhaler ; FEV 1 , Forced expiratory volume in one second ; FF , Formoterol fumarate ; G , Glycopyrronium ; ICS , Inhaled corticosteroid ; IND , Indacaterol ;
LABA , Long-acting beta 2 agonist ; LAMA , Long‐acting muscarinic antagonist ; MMAD , Mass median aerodynamic diameter ; PBS , Pharmaceutical Benefits Scheme ; pMDI , Pressurised metered dose inhaler ; TDI , Transition Dyspnea Index . References : 1 . Pharmaceutical Benefits Scheme ( PBS ). Available at : https :// www . pbs . gov . au . 2 . Papi et al ., Lancet 2018 ; 391:1076 – 84 . 3 . Singh et al ., Lancet 2016 ; 388:963 – 73 . 4 . Approved Trimbow ® Product Information .
Chiesi Australia Pty Ltd , Suite 3 , 22 Gillman Street , Hawthorn East , VIC . 3123 , Australia . Tel : + 61 3 9077 4486 ; Fax : + 61 3 8672 0792 ; Email : medicalaffairs . au @ chiesi . com ; Website : www . chiesi . com . au . Copyright © Chiesi 2022 . All rights reserved . Date of preparation : January 2022 . AU-TRI-2200007 . CHIE00011 .