TABLE 2.
Baseline
|
Week 8
|
|||||||
---|---|---|---|---|---|---|---|---|
ICS, n=154 | ICS/LABA, n=153 | P* | Total, n=312 | ICS, n=151 | ICS/LABA, n=146 | P* | Total, n=301 | |
Presence of the following asthma symptoms, n (%) | ||||||||
1. Daytime symptoms ≥4 days in the previous week | 133 (86.4) | 128 (83.7) | 0.527 | 265 (84.9) | 36 (23.8) | 29 (19.9) | 0.483 | 65 (21.6) |
2. Night-time symptoms ≥1 night in the previous week | 112 (72.7) | 108 (70.6) | 0.705 | 224 (71.8) | 44 (29.1) | 32 (21.9) | 0.184 | 77 (25.6) |
3. Mild infrequent exacerbations† | 56 (36.4) | 62 (40.5) | 0.483 | 118 (37.8) | 9 (6.0) | 7 (4.8) | 0.799 | 16 (5.3) |
4. Absenteeism due to asthma (school or work) in the previous week | 16 (10.4) | 28 (18.3) | 0.052 | 44 (14.1) | 3 (2.0) | 0 (0.0) | 0.248 | 4 (1.3) |
5. Restricted physical activity in the previous week | 93 (60.4) | 99 (64.7) | 0.480 | 193 (61.9) | 27 (17.9) | 23 (15.8) | 0.645 | 50 (16.6) |
6. SABA ≥4 doses in the previous week‡ | 112 (72.7) | 78 (51.0) | <0.001 | 191 (61.2) | 26 (17.2) | 21 (14.4) | 0.528 | 47 (15.6) |
7. FEV1 or PEF ≤90% of their personal best in the previous week | 39 (25.3) | 37 (24.2) | 0.895 | 77 (24.7) | 1 (0.7) | 5 (3.4) | 0.116 | 6 (2.0) |
8. Diurnal variability in PEF >10% to 15% in the previous week | 10 (6.5) | 18 (11.8) | 0.117 | 29 (9.3) | 1 (0.7) | 3 (2.1) | 0.364 | 4 (1.3) |
Patient is uncontrolled§ | 154 (100.0) | 153 (100.0) | NC | 312 (100.0) | 40 (26.5) | 32 (21.9) | 0.417 | 72 (23.9) |
Based on the χ2 test;
One exacerbation in the previous 3 months requiring a doctor visit or oral prednisone or an emergency room visit;
Excluding one dose/day before exercise;
Uncontrolled was defined by having at least 2 positive responses of the criteria listed above. P<0.001 based on the McNemar test for change in asthma control assessment between baseline and week 8 for total, inhaled corticosteroid (ICS) and ICS/long-acting beta-2-agonist (LABA) drug group for all asthma symptoms. The only exceptions were for asthma symptom 4 (P=0.004) and asthma symptom 8 (P=0.012) in the ICS drug group. FEV1 Forced expiratory volume in 1 s; NC Not calculable; PEF Peak expiratory flow; SABA Short-acting beta-2-agonist