Table 2.
A) Start or increase ICS (n = 11) | B) Stop or decrease ICS (n = 10) | C) All (n = 21) when assessed during: | |||||||
---|---|---|---|---|---|---|---|---|---|
Visit 1 (suboptimal Rx) |
Visit 2 (optimised Rx) |
Δ | Visit 1 (optimised Rx) |
Visit 2 (suboptimal Rx) |
Δ | Suboptimal Rx | Optimised Rx | Δ | |
Female (%) | 5 (45%) | – | – | 7 (70%) | – | – | 12 (57%) | – | – |
Age | 36 (33, 43) | – | – | 44 (27, 56) | – | – | 37.0 (31, 55) | – | – |
Atopy | 10 (91%) | – | – | 10 (100%) | – | – | 20 (95%) | – | – |
ICS dose (μg, budesonide equiv.) | 0 (0, 140) | 1000 (800, 1000) | 1000** | 775 (500, 850) | 0 (0, 500) | −775** | 0 (0, 375) | 800 (500, 1000) | 800*** |
ACQ7 | 1.71 (1.14, 2.14) | 0.71 (0.57, 1.07) | −1.00** | 0.57 (0.54, 0.90) | 1.22 (0.89, 1.82) | 0.65** | 1.71 (1.07, 2.07) | 0.57 (0.57, 1.00) | −1.14*** |
FEV1% predicted | 71.5 (68.2, 82.6) | 79.3 (69.5, 82.4) | 7.8 | 82.1 (76.2, 92.4) | 85.5 (73.0, 90.9) | 3.4 | 75.6 (69.6, 86.4) | 79.3 (74.1, 85.8) | 3.7* |
FEV1/FVC | 0.65 (0.63, 0.68) | 0.71 (0.59, 0.78) | 0.06 | 0.74 (0.65, 0.83) | 0.73 (0.63, 0.83) | −0.01 | 0.67 (0.64, 0.76) | 0.71 (0.65, 0.78) | 0.04 |
BDR (post-bronchodilator reversibility)% change | 15.4 (9.3, 21.8) | 11.1 (8.0, 15.5) | −4.3** | 5.0 (1, 8.6) | 7.7 (1.8, 11.9) | 2.7 | 11.4 (5.3, 16.2) | 8.6 (3.9, 12.5) | −2.8** |
FENO (ppb) | 124 (87–188) | 84 (26.6–110) | −40** | 44.0 (21.0, 74.0) | 62.0 (34.0, 98.0) | 18* | 89.0 (47.0, 165.5) | 51.0 (23.8, 90.0) | −38** |
EA (%) | 9 (82%) | 6 (55%) | −3 (−27%) | 2 (20%) | 4 (40%) | 2 (20%) | 13 (61.9%) | 8 (38.1%) | −5 (−23.8%) |
NEA (%) of which: | 2 (18%) | 5 (45%) | 3 (27%) | 8 (80%) | 6 (60%) | −2 (−20%) | 8 (38.1%) | 13 (61.9%) | 5 (23.8%) |
NA (%) | 1 (9%) | 1 (9%) | 0 (0%) | 0 (0%) | 3 (30%) | 3 (30%) | 4 (19.0%) | 1 (4.8%) | −3 (−14.3%) |
PGA (%) | 1 (9%) | 4 (36%) | 3 (27%) | 8 (80%) | 3 (30%) | −5 (−50%) | 4 (19.0%) | 12 (57.1%) | 8 (38.1%) |
Sputum eosinophils % | 6.9 (2.2, 17.2) | 3.1 (0.9, 9.1) | −5.4 | 1.4 (0.6, 1.7) | 0.9 (0, 7.4) | −0.5 | 4.4 (0.7, 15.3) | 1.5 (0.8, 4.8) | −2.9 |
Sputum neutrophils % | 27.4 (9.3, 43.7) | 30.4 (17.4, 38.7) | 3 | 38.0 (14.5, 45.1) | 43.9 (18.9, 63.9) | 5.9 | 35.8 (14, 53.9) | 34.5 (17.3, 43.2) | −1.3 |
TCC/ml | 2.33 (0.94, 3.08) | 2.08 (1.80, 3.25) | −0.25 | 1.23 (0.95, 2.07) | 0.89 (0.70, 1.47) | −0.34 | 1.26 (0.74, 2.44) | 1.8 (1.17, 3.07) | −0.54 |
Viability % (non-squamous cells) | 69.4 (56.6, 83.1) | 78.8 (67.0, 84.4) | 9.4 | 70.9 (63.5, 78.1) | 80.2 (65.5, 86.9) | 9.3 | 73.8 (60.3, 85.4) | 76.0 (64.0, 81.7) | 2.2 |
Sputum IL-8 (ng/ml) | 2.19 (0.58, 2.53) | 1.94 (1.19, 4.26) | −0.25 | 2.53 (1.35, 3.85) | 2.05 (1.02, 3.39) | −0.48 | 2.19 (0.93, 3.11) | 2.11 (1.28, 3.57) | −0.08 |
Sputum MMP-9 | 411 (259, 2490) | 637 (421, 1289) | 226 | 1160 (295, 1584) | 1293 (326, 2003) | 133 | 666 (277, 2042) | 1094 (376, 1408) | 428 |
NE detected (%) | 1 (9%) | 0 (0%) | −1 (−9%) | 0 (0%) | 3 (30%) | 3 (30%) | 4 (19%) | 0 (0%) | −4 (−19%) |
Endotoxin (EU/ml) | 2027 (1172, 2342) | 1235 (546, 1769) | −792* | 2227 (720, 4087) | 1879 (1477, 3054) | −348 | 1894 (1354, 2577) | 1361 (559, 2650) | −533 |
ICS dose – average daily dose ICS over recording period in μg budesonide equivalent. Data expressed as number (percentage) or median (IQR). Δ difference between median values of paired groups. ***p < 0.001, ** p < 0.01, * p < 0.05 when compared with matched group
A and B represent the data derived from the assessments as described (n = 11 go from sub-optimised to optimised, n = 10 from optimised to sub-optimised). C represents the data from all 21 CIT participants when data are stratified according to their treatment status