Table 3 Mean overall difference between roflumilast and placebo treatment.
| Mean difference (95% CI) | p Value | |
|---|---|---|
| Sputum characteristics | ||
| Total cell count (×105 cells/g)† | −33.6% (−48.8 to −13.8) | 0.002 |
| Weight (g)* | 0.15 (−0.56 to 0.86) | 0.68 |
| Viability (%)* | −2.0 (−4.4 to 0.3) | 0.091 |
| Squamous cell contamination (%)* | −1.8 (−6.0 to 2.5) | 0.41 |
| Cellular inflammation in sputum | ||
| Absolute number of neutrophils†‡ | −35.5% (−50.7 to −15.6) | 0.002 |
| Absolute number of eosinophils†‡ | −50.0% (−65.8 to −26.8) | <0.001 |
| Absolute number of macrophages†‡ | −24.4% (−43.9 to 2.0) | 0.067 |
| Absolute number of lymphocytes†‡ | −34.8% (−54.7 to −6.1) | 0.022 |
| % Neutrophils* | −1.6 (−4.8 to 1.6) | 0.31 |
| % Eosinophils† | −25.2% (−44.3 to 0.3) | 0.052 |
| % Macrophages* | 1.8 (−0.9 to 4.6) | 0.19 |
| % Lymphocytes† | −4.1% (−23.8 to 20.7) | 0.72 |
| Markers of inflammation in sputum supernatant | ||
| IL‐8 (ng/ml)† | −25.9% (−44.7 to −0.8) | 0.044 |
| Neutrophil elastase (μg/ml)† | −30.6% (−49.8 to −4.1) | 0.028 |
| Lactoferrin (μg/ml)† | −29.0% (−57.3 to 17.9) | 0.18 |
| ECP (μg/l)† | −34.3% (−53.1 to −7.9) | 0.015 |
| Markers of microvascular leakage in sputum supernatant | ||
| α2‐Macroglobulin (ng/ml)† | −40.8% (−55.0 to −22.3) | <0.001 |
| Systemic markers of inflammation | ||
| E‐selectin (ng/ml)† | −1.7% (−4.5 to 1.1) | 0.23 |
| TNFα (pg/ml)† | −10.4% (−19.7 to −0.1) | 0.047 |
| Lung function | ||
| Pre‐bronchodilator FEV1 (ml)* | 79.5 ml (54.0 to 105.1) | <0.001 |
| Post‐bronchodilator FEV1 (ml)* | 68.7 ml (12.9 to 124.5) | 0.018 |
IL, interleukin; ECP, eosinophil cationic protein; TNFα, tumour necrosis factor α; FEV1, forced expiratory volume in 1 s.
*Mean difference between treatments represents “absolute” difference between roflumilast and placebo treatment for sputum weight, viability, squamous cell contamination, percentage of neutrophils and percentage of macrophages in sputum, and pre‐ and post‐bronchodilator FEV1.
†”Relative” difference (mean ratio of change from baseline) for total cell count, number of neutrophils, eosinophils, macrophages and lymphocytes, percentage of eosinophils, percentage of lymphocytes, IL‐8, neutrophil elastase, lactoferrin, ECP, α2‐macroglobulin, E‐selectin and TNFα since these parameters were log‐transformed prior to analyses.
‡Unit of absolute cells in sputum ×105 cells/g sputum.