TABLE 3.
LUNG FUNCTION AND INFLAMMATION (ABSOLUTE DATA) AT BASELINE, EXACERBATION, 2 WEEKS AFTER EXACERBATION (POST-THERAPY) AND 6 WEEKS AFTER EXACERBATION (RECOVERY), FOR ALL EXACERBATIONS CATEGORIZED INTO BIOMARKER POSITIVE GIVEN PREDNISOLONE, BIOMARKER NEGATIVE GIVEN PREDNISOLONE, AND BIOMARKER NEGATIVE GIVEN PLACEBO
| Biomarker Positive Given Prednisolone |
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| Baseline | Exacerbation | 2 wk | 6 wk | |
| (n = 53) | (nE = 85) | (nE = 85) | (nE = 41) | |
| FEV1, L* | 1.16 (0.42) | 0.99 (0.41) | 1.17 (0.45) | 1.19 (0.41) |
| FEV1, % predicted* | 46 (18) | 39 (18) | 46 (19) | 46 (8) |
| Sputum total cell count, ×106/g† | 2.8 (1.9–4.2) | 5.4 (3.9–7.5) | 2.4 (1.6–3.6) | 2.4 (1.7–3.4) |
| Sputum neutrophils, % | 76 (24) | 78 (23) | 74 (21) | 71 (21) |
| Sputum eosinophils, %† | 1.0 (0.8–1.4) | 1.6 (1.1–2.3) | 0.7 (0.5–0.9) | 1.5 (0.9–2.6) |
| Blood total cell count, ×109 cells/L† | 9.1 (8.6–9.6) | 8.8 (8.3–9.3) | 11.6 (10.9–12.4) | 9.0 (8.1–9.9) |
| Blood neutrophil count, ×109 cells/L† | 5.7 (5.3–6.2) | 5.6 (5.2–6.0) | 8.1 (7.4–8.9) | 5.7 (5.0–6.5) |
| Blood eosinophil count, ×109 cells/L† | 0.30 (0.26–0.34) | 0.34 (0.31–0.38) | 0.19 (0.15–0.23) | 0.26 (0.19–0.34) |
| Blood eosinophil % | 3.9 (2.5) | 4.5 (2.7) | 2.3 (1.9) | 3.9 (3.9) |
| CRP, mg/L‡ | 5 (10) | 9 (22) | 3 (9) | 3 (6) |
| Biomarker Negative Given Prednisolone | ||||
| Baseline | Exacerbation | 2 wk | 6 wk | |
| (n = 26) | (nE = 39) | (nE = 39) | (nE = 23) | |
| FEV1, L* | 1.24 (0.49) | 1.15 (0.48) | 1.22 (0.45) | 1.22 (0.43) |
| FEV1, % predicted* | 48 (20) | 44 (19) | 48 (19) | 46 (17) |
| Sputum total cell count, ×106/g† | 2.4 (1.7–3.4) | 10.6 (7.0–16.1) | 3.8 (2.3–6.3) | 2.0 (1.1–3.5) |
| Sputum neutrophils, % | 73 (18) | 82 (21) | 80 (21) | 77 (18) |
| Sputum eosinophils, %† | 0.6 (0.5–0.9) | 0.5 (0.4 o 0.6) | 0.4 (0.3–0.6) | 0.5 (0.3–0.7) |
| Blood total cell count, ×109 cells/L† | 9.1 (8.1–10.1) | 10.8 (9.8–12.0) | 11.9 (10.4–13.7) | 8.4 (7.4–9.7) |
| Blood neutrophil count, ×109 cells/L† | 5.7 (5.0–6.6) | 7.7 (6.8–8.8) | 8.2 (7.0–9.7) | 5.2 (4.4–6.1) |
| Blood eosinophil count, ×109 cells/L† | 0.15 (0.12–0.18) | 0.10 (0.09–0.12) | 0.11 (0.09–0.14) | 0.12 (0.09–0.15) |
| Blood eosinophil % | 2.0 (1.4) | 1.1 (0.5) | 1.1 (0.8) | 1.7 (1.5) |
| CRP, mg/L‡ | 5 (8) | 18 (42) | 10 (20) | 6 (10) |
| Biomarker Negative Given Placebo | ||||
| Baseline | Exacerbation | 2 wk | 6 wk | |
| (n = 30) | (nE = 42) | (nE = 42) | (nE = 24) | |
| FEV1, L* | 1.26 (0.61) | 1.10 (0.58) | 1.23 (0.58) | 1.20 (0.54) |
| FEV1, % predicted* | 53 (20) | 47 (19) | 53 (19) | 50 (19) |
| Sputum total cell count, ×106/g† | 3.5 (2.2–4.4) | 8.1 (4.5–10.7) | 2.3 (1.4–2.7) | 1.7 (0.9–2.0) |
| Sputum neutrophils, % | 72 (25) | 88 (17) | 78 (18) | 77 (19) |
| Sputum eosinophils, %† | 0.7 (0.5–0.9) | 0.5 (0.4–0.5) | 0.7 (0.5–0.8) | 0.8 (0.4–0.9) |
| Blood total cell count, ×109 cells/L† | 7.8 (7.3–8.1) | 9.7 (8.7–10.2) | 8.2 (7.6–8.4) | 7.7 (7.0–7.9) |
| Blood neutrophil count, ×109 cells/L† | 5.1 (4.6–5.3) | 6.9 (6.0–7.4) | 5.4 (4.9–5.6) | 5.0 (4.5–5.2) |
| Blood eosinophil count, ×109 cells/L† | 0.15 (0.12–0.17) | 0.12 (0.10–0.13) | 0.14 (0.11–0.15) | 0.17 (0.13–0.18) |
| Blood eosinophil % | 2.2 (1.5) | 1.3 (0.5) | 2.0 (1.1) | 2.5 (1.5) |
| CRP, mg/L‡ | 3 (2) | 24 (67) | 3 (7) | 3 (5) |
Definition of abbreviation: CI = confidence interval; CRP = C-reactive protein; n = number of patients; nE = number of exacerbation events.
Data presented as mean (SD) unless otherwise stated.
*
Post-bronchodilator.
†
Geometric mean (95% CI).
‡
Median (interquartile range).