A prospective study of the effect of carbocysteine lysine salt on COPD exacerbations with or without inhaled steroids

Chronic obstructive pulmonary disease (COPD) is characterised by airway inflammation and oxidative stress contributing to corticosteroid resistance. Carbocysteinelysine salt (CLS) is a mucoactive drug with antinflammatory and antioxidant activities. The PEACE studyshowed a 25%reduction of COPD exacerbationsfor carbocysteine, with significant benefit in patients with g1 exacerbation, but only 17% of patients received inhaled steroids (IS). This is a prospective real life clinical trial evaluating the effect of CLS on COPD exacerbationsin addition to background therapy with or without IS in GOLD stage II-IV patients. As of 31-Jan-2014, 202 patients were included in the study with a minimum 3-month follow-up. Mean age was 69.3 yrs and M/F was 100/102. Of these, 42 patients with g2 exacerbationsat baseline (in the previous year) completed the 1-year study period: CLS was added to background therapy including IS in 40.5% and without IS in 59.5%. At 1 year of CLS treatment, only 59.5% of these 42 patients experienced g2 exacerbations,respectively 64.7% and 56% in the group receiving vs. non receiving IS (NS). Also the mean number of exacerbationsdeclined significantly, overall from 2.74 to 1.67 (Δ=-39.1%, pl0.0001): significant improvement was seen both in IS (from 2.94 to 2, Δ=-32%, p=0.0038) and non-IS patients (from 2.6 to 1.44, Δ=-44.6%, p=0.0008), with no significant difference between the 2 groups (p=0.6001). These preliminary results show that addition of CLS allows significant reduction of COPD exacerbationsin patients with g2 exacerbationsat baseline. At 12 months, the effect of CLS on exacerbationsis similar for background therapy with or without IS.