Characteristics | Extrafine ICS step-up | FDC fine-particle ICS/LABA | ||
ICS step-up | Separate ICS+LABA | FDC ICS/LABA | Separate ICS+LABA | |
Subjects n | 3232 | 6464 | 7529 | 15 058 |
Female# | 1959 (60.6) | 3918 (60.6) | 4689 (62.3) | 9378 (62.3) |
Age at index date years# | 42.4±16.4 | 42.3±16.4 | 42.1±16.1 | 42.2±15.9* |
Smoking status¶ | ||||
Current smoker | 625 (22.3) | 1165 (21.5)*** | 1564 (22.7) | 2992 (24.0)*** |
Ex-smoker | 503 (18.0) | 956 (17.7) | 1255 (18.2) | 2190 (17.6) |
Nonsmoker | 1673 (59.7) | 3291 (60.8) | 4076 (59.1) | 7283 (58.4) |
Nonsmokers aged 61–80 years | 426 (13.2) | 826 (12.8) | 878 (11.7) | 1694 (11.2) |
Risk-domain asthma control# | 2094 (64.8) | 4188 (64.8) | 4400 (58.4) | 8800 (58.4) |
Severe exacerbations | ||||
0 | 2412 (74.6) | 4745 (73.4)* | 5244 (69.7) | 10 225 (67.9)*** |
1 | 573 (17.7) | 1175 (18.2) | 1550 (20.6) | 3186 (21.2) |
2 | 167 (5.2) | 378 (5.8) | 499 (6.6) | 1045 (6.9) |
≥3 | 80 (2.5) | 166 (2.6) | 236 (3.1) | 602 (4.0) |
Acute respiratory events | ||||
0 | 2124 (65.7) | 4218 (65.3) | 4522 (60.1) | 8907 (59.2) |
1 | 701 (21.7) | 1391 (21.5) | 1859 (24.7) | 3725 (24.7) |
2 | 267 (8.3) | 560 (8.7) | 731 (9.7) | 1473 (9.8) |
≥3 | 140 (4.3) | 295 (4.6) | 417 (5.5) | 953 (6.3) |
Mean daily SABA dose# | ||||
0 μg·day−1 | 131 (4.1) | 262 (4.1) | 208 (2.8) | 416 (2.8) |
1–200 μg·day−1 | 1318 (40.8) | 2636 (40.8) | 2563 (34.0) | 5126 (34.0) |
201–400 μg·day−1 | 814 (25.2) | 1628 (25.2) | 2022 (26.9) | 4044 (26.9) |
>400 μg·day−1 | 969 (30.0) | 1938 (30.0) | 2736 (36.3) | 5472 (36.3) |
Last ICS dose before index date μg·day−1#,+ | 193±49 | 194±54*** | 295±187 | 293±185* |
ICS dose at index date μ·day−1 | 394±98 | 194±53*** | 301±194 | 292±184*** |
Asthma consultations/severe exacerbations# | ||||
0 | 1157 (35.8) | 2314 (35.8) | 2351 (31.2) | 4702 (31.2)* |
1 | 1136 (35.1) | 2272 (35.1) | 2542 (33.8) | 5084 (33.8) |
2 | 629 (19.5) | 1126 (17.4)*** | 1603 (21.3) | 3048 (20.2) |
≥3 | 310 (9.6) | 752 (11.6) | 1033 (13.7) | 2224 (14.8) |
Data are presented as n (%) or mean±sd, unless otherwise stated. Additional baseline data can be found in table S2. ICS: inhaled corticosteroids; LABA: long-acting β2-agonist; FDC: fixed-dose combination; SABA: short-acting β2-agonist.#: matching variable; ¶: data were available for 2801 (86.7%) and 5412 (83.7%) patients in the ICS and separate ICS+LABA cohorts, respectively, and for 6895 (91.6%) and 12 465 (82.8%) in the ICS/LABA combination and separate ICS+LABA cohorts, respectively; +: for the purposes of matching, doses of budesonide and large-particle beclomethasone (Clenil Modulite, Chiesi) were halved, and 250 and 500 μg of fluticasone were set to be equivalent to 200 and 400 μg of extrafine beclomethasone, respectively. At the index date, ICS doses are reported as half budesonide doses, while extrafine beclomethasone and fluticasone doses are reported without modification. *: p≤0.05, ***p<0.001, conditional logistic regression for two-way comparison between cohorts.