Abstract
Chronic obstructive pulmonary disease (COPD) is characterised by airway inflammation and oxidative stress contributing to corticosteroid resistance. Carbocysteine lysine salt (CLS) is a mucoactive drug with antinflammatory and antioxidant activities. The PEACE studyshowed a 25%reduction of COPD exacerbations for carbocysteine, with significant benefit in patients with >1 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 exacerbations in 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 >2 exacerbations at 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 >2 exacerbations,respectively 64.7% and 56% in the group receiving vs. non receiving IS (NS). Also the mean number of exacerbations declined significantly, overall from 2.74 to 1.67 (Δ=-39.1%, p<0.0001): 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 exacerbations in patients with >2 exacerbations at baseline. At 12 months, the effect of CLS on exacerbations is similar for background therapy with or without IS.
- © 2014 ERS