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Table 1 Summary of clinical trial datasets

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

DatasetN (original)N (analysis)Duration (months)Treatment groups*Endpoints
A19641746121) BUD/FM 320
2) BUD/FM 160
3) FM
4) PBO
Primary: pre- and
post-dose FEV1
Secondary: number of exacerbations
B12191072121) BUD/FM 320
2) BUD/FM 160
3) FM
Primary: number of exacerbations
C1704161361) 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
D19451218121) SOC + RFL
2) SOC
Primary: rate of
exacerbations
E23542049121) SOC + RFL
2) SOC
Primary: rate of
exacerbations
  1. 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