Implementing lessons learned from previous bronchial biopsy trials in a new randomized controlled COPD biopsy trial with roflumilast

Table 1 Secondary endpoints evaluated from baseline or randomization to the end of the double-blind intervention period

Biopsy material	Induced sputum	Blood serum	Pulmonary function changes
Sub-mucosa cell counts (cells/mm²): CD68+, Neutrophils, CD4+, CD45+	Total and differential cell counts in induced sputum, absolute (cells/mL) and percentage (%): Neutrophils, Macrophages, Eosinophils, Lymphocytes	Concentration of inflammatory biomarkers: Inflammatory mediators* (Human InflammationMAP® v 1.0; Myriad RBM)	Change from randomization to the end of the intervention period:, FEV₁FVC FEV₁/FVC ratio
Bronchial epithelium cell counts (cells/mm²): CD8+ CD68+	Concentration of inflammatory biomarkers: Inflammatory mediators* (Human InflammationMAP® v 1.0; Myriad RBM)

FEV₁: forced expiratory volume in one second; FVC: forced vital capacity.
*Alpha-1 antitrypsin, alpha-2 macroglobulin, beta-2 microglobulin, brain-derived neurotrophic factor, complement 3, C-reactive protein, eotaxin-1, factor VII, ferritin, fibrinogen, granulocyte-macrophage colony-stimulating factor, haptoglobin, intercellular adhesion molecule-1, interferon gamma, interleukin (IL)-1 alpha, IL-1 beta, IL-1 receptor antagonist, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12 p40, IL-12 p70, IL-15, IL-17, IL-23, macrophage inflammatory protein-1 alpha, macrophage inflammatory protein-1 beta, matrix metalloproteinase (MMP) type 2, MMP type 3, MMP type 9, monocyte chemotactic protein-1, RANTES, stem cell factor, tissue inhibitor of metalloproteinases 1, tumor necrosis factor (TNF)-alpha, TNF-beta, TNF-receptor 2, vascular cell adhesion molecule-1, vascular endothelial growth factor, von Willebrand factor, vitamin D-binding protein.

ISSN: 1471-2466