Table 2 Clinical outcomes for patients treated with BUD/FORM MRT or fixed-dose BUD, stratified by baseline reliever use (<1, 1–2 and >2 occasions/day)
BUD/FORM MRT (All patients) (n = 626) | Fixed-dose BUD (All patients) (n = 613) | Baseline reliever use subgroup | ||||||
|---|---|---|---|---|---|---|---|---|
<1 occasion/day | 1–2 occasions/day | >2 occasions/day | ||||||
BUD/FORM MRT (n = 168) | Fixed-dose BUD (n = 155) | BUD/FORM MRT (n = 257) | Fixed-dose BUD (n = 253) | BUD/FORM MRT (n = 201) | Fixed-dose BUD (n = 205) | |||
Severe exacerbations | ||||||||
Patients with severe exacerbation, n (%) | 38 (6.1) | 72 (11.7) | 8 (4.8) | 11 (7.1) | 11 (4.3) | 24 (9.5) | 19 (9.5) | 37 (18.0) |
Rate, exacerbations per year | 0.14 | 0.23 | 0.09 | 0.14 | 0.09 | 0.16 | 0.22 | 0.37 |
FEV1 | ||||||||
FEV1, L | 2.62 (0.8) | 2.46 (0.7) | 2.69 (0.7) | 2.55 (0.7) | 2.66 (0.8) | 2.50 (0.8) | 2.51 (0.8) | 2.34 (0.7) |
Change from baseline in FEV1, L | 0.21 (0.3) | 0.11 (0.3) | 0.18 (0.3) | 0.08 (0.3) | 0.20 (0.3) | 0.10 (0.3) | 0.25 (0.4) | 0.16 (0.4) |
Reliever use | ||||||||
Treatment period reliever use, occasions/day | 0.84 (1.2) | 1.27 (1.5) | 0.43 (0.7) | 0.50 (0.8) | 0.60 (0.7) | 0.93 (1.0) | 1.50 (1.7) | 2.28 (1.7) |
Change from baseline in reliever use, occasions/day | −1.00 (1.3) | −0.65 (1.3) | −0.15 (0.7) | −0.15 (0.8) | −0.89 (0.8) | −0.56 (1.0) | −1.84 (1.6) | −1.14 (1.7) |