Step up to triple therapy versus switch to dual bronchodilator therapy in patients with COPD on an inhaled corticosteroid/long-acting β2-agonist: post-hoc analyses of KRONOS

Table 3 Moderate/severe exacerbation rates: participants in the Exacerbations^{(No recent)} population^a

	Step up to ICS/LAMA/LABA	Switch to LAMA/LABA	Stay on ICS/LABA
	BGF 320/14.4/10 μg	GFF 14.4/10 μg	BFF 320/10 μg	BUD/FORM 400/12 μg
n	188	196	85	85
Patients with exacerbations, n (%)	28 (14.9)	47 (24.0)	15 (17.6)	18 (21.2)
Events, n	36	59	17	22
Estimated rate of exacerbations (SE) over 24 weeks, per year^{b, c}	0.43 (0.08)	0.76 (0.13)	0.47 (0.13)	0.70 (0.18)

COPD exacerbations were considered separate events provided that 7 or more days were between the recorded stop date of the earlier event and start date of the later
^aParticipants on ICS/LABA in the 30 days before screening and without exacerbation history in the previous 12 months. ^bModel-estimated rate. ^cThe rate of exacerbations per year was the total number of exacerbations divided by the total years of exposure across all participants for the treatment. Time during an exacerbation or in the 7 days following an exacerbation was not included in the calculation of exposure
BFF, budesonide/formoterol fumarate dihydrate (via MDI); BGF, budesonide/glycopyrronium/formoterol fumarate dihydrate; BUD/FORM, budesonide/formoterol fumarate dihydrate (via DPI); COPD, chronic obstructive pulmonary disease; DPI, dry-powder inhaler; GFF, glycopyrronium/formoterol fumarate dihydrate; ICS, inhaled corticosteroid; LABA, long-acting β₂-agonist; LAMA, long-acting muscarinic antagonist; MDI, metered-dose inhaler; SE, standard error

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