Improving the evaluation of COPD exacerbation treatment effects by accounting for early treatment discontinuations: a post-hoc analysis of randomized clinical trials

Table 1 Summary of clinical trial datasets

Dataset	N (original)	N (analysis)	Duration (months)	Treatment groups*	Endpoints
A	1964	1746	12	1) BUD/FM 320 2) BUD/FM 160 3) FM 4) PBO	Primary: pre- and post-dose FEV₁ Secondary: number of exacerbations
B	1219	1072	12	1) BUD/FM 320 2) BUD/FM 160 3) FM	Primary: number of exacerbations
C	1704	1613	6	1) BUD/FM 320 2) BUD/FM 160 3) BUD 320 + FM 4) BUD 320 5) FM 6) PBO	Primary: pre- and post-dose FEV₁ Secondary: number of exacerbations
D	1945	1218	12	1) SOC + RFL 2) SOC	Primary: rate of exacerbations
E	2354	2049	12	1) SOC + RFL 2) SOC	Primary: rate of exacerbations

BUD budesonide, FEV₁ forced expiratory volume in 1 s, FM formoterol, PBO placebo, RFL roflumilast, SOC standard of care, * - Treatment groups: BUD/FM 320 - BUD/FM pMDI (pressurized metered-dose inhaler) 160/4.5 μg × 2 inhalations bid (twice daily) (320/9 μg), BUD/FM 160 - BUD/FM pMDI 80/4.5 μg × 2 inhalations bid (160/9 μg), FM - FM DPI (dry powder inhaler) 4.5 mcg × 2 inhalations bid (9 μg), BUD 320 - BUD pMDI 160 μg × 2 inhalations bid (320 μg), BUD 320 + FM - BUD pMDI 160 μg × 2 inhalations bid (320 μg) and FM DPI 4.5 μg × 2 inhalations bid (9 μg), PBO - use of SABA (short-acting beta agonists) only, SOC - standard of care with inhaled corticosteroid and long-acting beta agonist +/− long-acting muscarinic receptor agonist, SOC + RFL - standard of care and RFL 500 μg once daily. The reference treatment in each dataset is marked in bold

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