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

Gregorino Paone, Luigi Lanata, Patrizio Palermo, Michela Bagnasco, Simona Toti, Federico Saibene, Barbara Moscatelli, Alessandra Monguzzi, Giovanni Puglisi
European Respiratory Journal 2014 44: 4667; DOI:
Gregorino Paone
1Department of Medicine, Respiratory Disease Section, San Camillo Forlanini Hospital, Rome, Italy
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Luigi Lanata
2Medical Department, Dompé SpA, Milan, Italy
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Patrizio Palermo
1Department of Medicine, Respiratory Disease Section, San Camillo Forlanini Hospital, Rome, Italy
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Michela Bagnasco
2Medical Department, Dompé SpA, Milan, Italy
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Simona Toti
1Department of Medicine, Respiratory Disease Section, San Camillo Forlanini Hospital, Rome, Italy
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Federico Saibene
2Medical Department, Dompé SpA, Milan, Italy
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Barbara Moscatelli
3Department of Medicine, Respiratory Disease Section, Fatebenefratelli, Isola Tiberina Hospital, Rome, Italy
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Alessandra Monguzzi
2Medical Department, Dompé SpA, Milan, Italy
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Giovanni Puglisi
1Department of Medicine, Respiratory Disease Section, San Camillo Forlanini Hospital, Rome, Italy
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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.

  • Chronic disease
  • © 2014 ERS
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A prospective study of the effect of carbocysteine lysine salt on COPD exacerbations with or without inhaled steroids
Gregorino Paone, Luigi Lanata, Patrizio Palermo, Michela Bagnasco, Simona Toti, Federico Saibene, Barbara Moscatelli, Alessandra Monguzzi, Giovanni Puglisi
European Respiratory Journal Sep 2014, 44 (Suppl 58) 4667;

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A prospective study of the effect of carbocysteine lysine salt on COPD exacerbations with or without inhaled steroids
Gregorino Paone, Luigi Lanata, Patrizio Palermo, Michela Bagnasco, Simona Toti, Federico Saibene, Barbara Moscatelli, Alessandra Monguzzi, Giovanni Puglisi
European Respiratory Journal Sep 2014, 44 (Suppl 58) 4667;
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