Abstract
Background: CHF6001 is a selective inhaled PDE4i (NEXThaler®). The aim of this study was to assess the effects of CHF6001 on markers of inflammation in sputum and blood. Methods: In this randomized, double-blind, 3-way crossover study, moderate-to-severe COPD subjects with chronic bronchitis (CB) received CHF6001 1600 or 3200µg daily or placebo for 32 days on top of ICS/LABA/LAMA therapy. CHF6001 concentrations and biomarkers of inflammation were analyzed in sputum supernatant and whole blood, plasma or serum. A post-hoc microarray gene expression analysis in blood and sputum cells was also carried out. Results: 61 patients were randomized. CHF6001 sputum concentrations were ~2000-fold higher than in plasma. In sputum supernatant, both doses significantly (p Conclusion: Both doses of CHF6001 significantly decreased a number of key biomarkers of airway inflammation in COPD patients with CB. Moreover, these effects were essentially localized to the lung with inhaled delivery limiting systemic exposure
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