Table 1.
Demographics and clinical characteristics according to prestudy treatment (pooled SYGMA 1 and 2)
| Overall |
Uncontrolled on BD (Subgroup 1) |
Well Controlled on ICS or LTRA (Subgroup 2) |
||||
|---|---|---|---|---|---|---|
| As-needed BUD–FORM (N = 3,366) | BUD Maintenance + As-needed Terbutaline (N = 3,369) | As-needed BUD–FORM (N = 1,524) | BUD Maintenance + As-needed Terbutaline (N = 1,551) | As-needed BUD–FORM (N = 1,842) | BUD Maintenance + As-needed Terbutaline (N = 1,818) | |
| Age, yr, mean (SD) | 40.7 (16.9) | 40.1 (17) | 39.5 (16.4) | 38.5 (16.5) | 41.7 (17.2) | 41.4 (17.2) |
| Female sex, n (%) | 2,085 (61.9) | 2,086 (61.9) | 920 (60.4) | 930 (60.0) | 1,165 (63.2) | 1,156 (63.6) |
| Pre-bronchodilator FEV1% predicted at study entry, mean (SD) | 85.96 (12.44) | 85.57 (12.26) | 79.28 (12.08) | 79.16 (12.27) | 91.48 (9.74) | 91.03 (9.24) |
| Pre-bronchodilator FEV1% predicted at baseline, mean (SD) | 84.33 (14.02) | 84.15 (13.93) | 80.27 (14.32) | 79.63 (14.26) | 87.68 (12.85) | 88.00 (12.40) |
| Reversibility at baseline, %, mean (SD) | 15.01 (12.00) | 15.00 (12.48) | 17.09 (12.63) | 17.45 (13.80) | 13.30 (11.16) | 12.93 (10.81) |
| Time since asthma diagnosis, yr, median (IQR) | 7.3 (2.6–15.5) | 6.9 (2.6–15.1) | 9.1 (3.3–19.0) | 9.1 (3.2–18.4) | 6.0 (2.3–12.9) | 5.7 (2.2–12.1) |
| Severe exacerbation in the last 12 mo, n (%) | ||||||
| 0 | 2,650 (78.7) | 2,668 (79.2) | 1,175 (77.1) | 1,192 (76.9) | 1,475 (80.1) | 1,476 (81.2) |
| 1 | 595 (17.7) | 574 (17.0) | 270 (17.7) | 285 (18.4) | 325 (17.6) | 289 (15.9) |
| ⩾2 | 121 (3.6) | 127 (3.8) | 79 (5.2) | 74 (4.7) | 42 (2.3) | 53 (2.9) |
| ACQ-5 score at study entry, mean (SD) | 1.53 (0.97) | 1.56 (0.99) | 1.77 (0.95) | 1.82 (0.96) | 1.34 (0.95) | 1.33 (0.95) |
| ACQ-5 score at baseline, mean (SD) | 1.53 (0.92) | 1.54 (0.92) | 1.61 (0.91) | 1.66 (0.90) | 1.47 (0.93) | 1.43 (0.93) |
Definition of abbreviations: ACQ-5 = Asthma Control Questionnaire (5-item version); BD = bronchodilator; BUD = budesonide; FEV1 = forced expiratory volume in 1 second; FORM = formoterol; ICS = inhaled corticosteroid; IQR = interquartile range; LTRA = leukotriene receptor antagonist; SABA = short-acting β2-agonist; SD = standard deviation; SYGMA = Symbicort Given as Needed in Mild Asthma.
“Uncontrolled on BD” indicates patients whose asthma was uncontrolled on as-needed short-acting BDs. The ACQ-5 consists of five questions concerning symptoms of asthma during the last week, each of which is scored on a range from 0 (no impairment) to 6 (maximum impairment); the minimal clinically important difference is 0.5 units. Study entry is defined as assessment at visit 2 (i.e., the start of run-in). Baseline is defined as the assessment at visit 3 (i.e., the end of 2–4 weeks’ run-in on SABA alone [randomization]).