TABLE 2.
LUNG FUNCTION AND INFLAMMATION AT BASELINE AND EXACERBATION IN ALL EXACERBATIONS CAPTURED CATEGORIZED AS BLOOD EOSINOPHIL BIOMARKER POSITIVE AND BIOMARKER NEGATIVE
| Biomarker Negative (n = 56, nE = 81) |
Biomarker Positive (n = 53, nE = 85) |
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| Baseline | Exacerbation | Mean Difference (95% CI)* | P Value | Baseline | Exacerbation | Mean Difference (95% CI)* | P Value | |
| FEV1, L† | 1.26 (0.56) | 1.13 (0.53) | −0.13 (−0.19 to −0.07) | <0.01 | 1.16 (0.42) | 0.99 (0.41) | −0.17 (−0.22 to −0.12) | <0.01 |
| FEV1, % predicted† | 51 (20) | 46 (19) | −5 (−7 to −3) | <0.01 | 46 (18) | 39 (18) | −7 (−9 to −5) | <0.01 |
| CRQ score, units | 4.00 (1.13) | 3.11 (1.05) | −0.88 (−1.06 to −0.70) | <0.01 | 3.99 (1.20) | 3.03 (0.99) | −0.96 (−1.16 to −0.77) | <0.01 |
| Sputum total cell count, ×106/g‡ | 3.0 (2.2–4.0) | 8.8 (6.1–12.6) | 3.0 (2.0 to 4.3) | <0.01 | 2.9 (1.9–4.4) | 5.6 (3.9–7.9) | 2.0 (1.2 to 3.1) | <0.01 |
| Sputum neutrophils, % | 72 (22) | 85 (20) | 12 (6 to 19) | <0.01 | 80 (20) | 80 (22) | 0.5 (−7 to 8) | 0.90 |
| Sputum eosinophils, %‡ | 0.7 (0.5–0.9) | 0.5 (0.4–0.5) | 0.7 (0.5 to 0.9) | <0.01 | 1.1 (0.8–1.6) | 1.7 (1.1–2.6) | 1.5 (0.9 to 2.3) | 0.09 |
| Blood total cell count, ×109 cells/L‡ | 8.4 (7.8–8.9) | 10.3 (9.5–11.1) | 1.2 (1.2 to 1.5) | <0.01 | 9.1 (8.6–9.6) | 8.8 (8.3–9.3) | 1.0 (0.9 to 1.0) | 0.19 |
| Blood neutrophil count, ×109 cells/L‡ | 5.3 (4.9–5.8) | 7.3 (6.6–8.1) | 1.4 (1.3 to 1.5) | <0.01 | 5.7 (5.3–6.2) | 5.6 (5.2–6.0) | 1.0 (0.9 to 1.1) | 0.50 |
| Blood eosinophil count, ×109 cells/L‡ | 0.15 (0.13–0.17) | 0.11 (0.10–0.13) | 0.8 (0.7 to 0.9) | <0.01 | 0.30 (0.26–0.34) | 0.34 (0.31–0.38) | 1.2 (1.1 to 1.3) | <0.01 |
| Blood eosinophil % | 2.1 (1.4) | 1.2 (0.5) | −0.9 (−1.1 to −0.7) | <0.01 | 3.9 (2.5) | 4.4 (2.6) | 0.6 (0.0 to 1.1) | 0.05 |
| CRP, mg/L | 3 (5) | 20 (49) | 12 (29) | <0.01 | 5 (10) | 9 (22) | 0 (13) | 0.04 |
Definition of abbreviations: CI = confidence interval; CRQ = Chronic Respiratory Disease Questionnaire score; CRP = C-reactive protein; n = number of patients; nE = number of exacerbation events.
Statistical analysis performed using a paired t test analysis or Wilcoxon signed rank test. Differences between exacerbation and baseline presented as mean difference (95% CI of difference), fold difference (95% CI of fold difference), and median (interquartile range) of differences as appropriate. Data presented as mean (SD) unless otherwise stated.
Mean, median, or fold difference as appropriate.
Post-bronchodilator.
Geometric mean (95% CI).