Proportion of participants in each ACQ-5 group category: ‘well-controlled’ (≤0.75), ‘partly controlled’ (>0.75 to <1.5) and ‘inadequately controlled’ (≥1.5) asthma by visit and end of study, Novel START
| Visit | Budesonide–formoterol ‘as needed’, n (%) | Budesonide maintenance two times per day, n (%) | ||||||
| N | ‘Well-controlled’ ≤0.75 | ‘Partly controlled’ 0.75 to <1.5 | ‘Inadequately controlled’ ≥1.5 | N | ‘Well controlled’ ≤0.75 | ‘Partly controlled’ 0.75 to <1.5 | ‘Inadequately controlled’ ≥1.5 | |
| Visit 1 (Baseline) | 220 | 71 (32.3) | 82 (37.3) | 67 (30.5) | 225 | 71 (31.6) | 97 (43.1) | 57 (25.3) |
| Visit 2 (Week 6) | 208 | 81 (38.9) | 97 (46.6) | 30 (14.4) | 206 | 113 (54.9) | 70 (34.0) | 23 (11.2) |
| Visit 3 (Week 12) | 198 | 92 (46.5) | 71 (35.9) | 35 (17.7) | 203 | 121 (59.6) | 61 (30.1) | 21 (10.3) |
| Visit 4 (Week 22) | 183 | 94 (51.4) | 73 (39.9) | 16 (8.7) | 182 | 114 (62.6) | 41 (22.5) | 27 (14.8) |
| Visit 5 (Week 32) | 174 | 98 (56.3) | 50 (28.7) | 26 (14.9) | 171 | 113 (66.1) | 37 (21.6) | 21 (12.3) |
| Visit 6 (Week 42) | 170 | 93 (54.7) | 51 (30.0) | 26 (15.3) | 155 | 101 (65.2) | 36 (22.2) | 18 (11.6) |
| Visit 7 (Week 52)* | 196 | 117 (59.7) | 55 (28.1) | 24 (12.2) | 197 | 123 (62.4) | 45 (22.8) | 29 (14.7) |
| End of study (LOCF)† | 214 | 126 (58.9) | 63 (29.4) | 25 (11.7) | 214 | 132 (61.7) | 51 (23.8) | 31 (14.5) |
*Visit 7 represents ACQ-5 scores collected at withdrawal from the study or at completion of the study (week 52)
†LOCF except if only a baseline reading was available; the number missing any observations after baseline was 6 for budesonide–formoterol ‘as needed’ and 11 for budesonide maintenance two times per day.
ACQ-5, Asthma Control Questionnaire Version 5; LOCF, last observation carried forward; N, number of patients in each treatment group at each visit; n, number of patients in each ACQ-5 category.