Effect of the inhalation inhibitor PDE-4 CHF6001 on some pathogenetic links in chronic obstructive pulmonary disease development

CHF6001 is a new inhaled phosphodiesterase-4 inhibitor that is safe and well tolerated by both healthy people and patients with bronchial asthma. The effect of CHF6001, in addition to standard triple therapy for chronic obstructive pulmonary disease, was evaluated on some inflammatory markers in induced sputum and blood in 61 patients (54 completed the study) with chronic obstructive pulmonary disease and chronic bronchitis. From October 2016 to November 2017, a multicenter, three-period (every 32 days), tripartite, placebo-controlled, double-blind, complete block cross-sectional study was conducted in Great Britain and Germany. Patients were treated by CHF6001 at doses of 800 or 1600 µg, or the corresponding placebo using the dry powder inhaler NEXThaler. The induced sputum was collected on day 1 before the treatment and days 20, 26, and 32 after the treatment. Blood was also collected on day 1 before the treatment and day 32 before and after the treatment. Result analyses took into account the inflammatory biomarkers in induced sputum and blood, respiratory function, and symptoms and side effects. CHF6001, which supplements triple therapy in patients with moderate to severe chronic obstructive pulmonary disease and chronic bronchitis, was well tolerated and significantly reduces the number of key biomarkers of airway inflammation in sputum and blood after 32 days of treatment. CHF6001, administered by inhalation, creates a high therapeutic concentration in the lungs compared with other systemic phosphodiesterase-4 inhibitors and improves the therapeutic index due to anti-inflammatory effects while minimizing the possible side effects typical of the latter.