Trimbow pMDI 172/5/9 contains the same delivered doses of formoterol fumarate dihydrate (5 microgram) and glycopyrronium (9 microgram) as the existing 87/5/9 inhaler, with a higher (172 microgram) dose of beclometasone dipropionate.
Trimbow pMDI 172/5/9 is indicated for maintenance treatment of asthma in adults not adequately controlled with a maintenance combination of a long-acting β2 agonist (LABA) and high dose of inhaled corticosteroid (ICS), and who experienced one or more asthma exacerbations in the previous year. The recommended and maximum dose is two puffs twice daily.
The aerosol particles of Trimbow are on average much smaller than the particles delivered in non-extrafine formulations. For beclometasone dipropionate, this results in a more potent effect than formulations with a non-extrafine particle size distribution.
The randomised, double-blind phase III TRIGGER study compared two twice-daily doses of extrafine beclometasone/formoterol/glycopyrronium 172/5/9 (n=573) with two twice-daily doses of a fixed-dose combination of beclometasone/formoterol 200/6 microgram alone (delivered dose 177.7/5.1 microgram) (n=576) or on top of two once-daily doses of tiotropium 2.5 microgram (n=288).
The primary objective of the study was to demonstrate superiority of beclometasone/formoterol/glycopyrronium 172/5/9 over dual high-dose ICS/LABA in terms of the co-primary endpoints: change from baseline in pre-dose FEV1 at week 26 and the rate of moderate and severe exacerbations over 52 weeks.
Analysis showed that beclometasone/formoterol/glycopyrronium 172/5/9 reduced the rate of moderate/severe exacerbations by 12% compared with the fixed combination of beclometasone/formoterol 200/6 microgram, although this effect did not achieve statistical significance (rate ratio 0.88 [95% CI 0.75–1.03], p=0.11).
Beclometasone/formoterol/glycopyrronium 172/5/9 did significantly improve the second co-primary endpoint of pre-dose FEV1 compared with beclometasone/formoterol 200/6 microgram after 26 weeks of treatment (+73ml [95% CI 26–120], p=0.0025).
Unlike Trimbow pMDI 87/5/9, the higher-strength inhaler is not licensed for use in COPD.