Proportion of participants with clinically relevant changes from baseline in ACQ-5 Scores (improved, no difference, worsened) by visit and end of study, Novel START
| Visit | Budesonide–formoterol ‘as needed’ n/N (%) | Budesonide maintenance two times per day n/N (%) | ||||||
| N | Improved | No difference | Worsened | N | Improved | No difference | Worsened | |
| Visit 2 (Week 6) | 208 | 58 (27.9) | 125 (60.1) | 25 (12.0) | 206 | 81 (39.2) | 105 (51.0) | 20 (9.7) |
| Visit 3 (Week 12) | 198 | 62 (31.3) | 115 (58.1) | 21 (10.6) | 203 | 96 (47.3) | 92 (45.3) | 15 (7.4) |
| Visit 4 (Week 22) | 183 | 67 (36.6) | 101 (55.2) | 15 (8.2) | 182 | 92 (50.6) | 74 (40.7) | 16 (8.8) |
| Visit 5 (Week 32) | 174 | 62 (35.6) | 85 (48.9) | 27 (15.5) | 171 | 83 (48.5) | 74 (43.3) | 14 (8.2) |
| Visit 6 (Week 42) | 170 | 56 (32.9) | 90 (52.9) | 24 (14.2) | 155 | 79 (51.0) | 62 (40.0) | 14 (9.0) |
| Visit 7 (Week 52)* | 196 | 77 (39.3) | 96 (49.0) | 23 (11.7) | 197 | 89 (45.2) | 80 (40.6) | 28 (14.2) |
| End of study (LOCF)† | 214 | 82 (38.3) | 108 (50.5) | 24 (11.2) | 214 | 96 (44.9) | 89 (41.6) | 29 (13.6) |
Categories are based on the MCID for ACQ-5 and are defined as follows: improved (a decrease from baseline of at least 0.5); worsened (an increase from baseline of at least 0.5) and no difference (an increase or decrease from baseline of less than 0.5).
*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; MCID, minimal clinically important difference; n, number of patients in each ACQ-5 category; short-acting β2-agonist (salbutamol); N, number of patients in each treatment group at each visit.