Obstructive Lung Diseases: COPD Pharmacotherapy |

The Efficacy of CSL in COPD Patients Exacerbations Treated With or Without Inhaled Steroids FREE TO VIEW

Gregorino Paone, MD; Luigi Lanata, MD; Federico Saibene, MD; Barbara Moscatelli, MD; Renato Delli Colli, MD; Augusto Bevilacqua, MD; Giovanni Puglisi, MD
Author and Funding Information

Dompé Farmaceutici, Milan, Italy

Copyright 2016, American College of Chest Physicians. All Rights Reserved.

Chest. 2016;149(4_S):A392. doi:10.1016/j.chest.2016.02.407
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SESSION TITLE: COPD Pharmacotherapy

SESSION TYPE: Original Investigation Poster

PRESENTED ON: Saturday, April 16, 2016 at 11:45 AM - 12:45 PM

PURPOSE: Chronic obstructive pulmonary disease (COPD) is a progressive disease that makes it hard to breathe. It is characterized by mucus alterations, airway inflammation and oxidative stress contributing to corticosteroid resistance. Carbocysteine lysine salt monohydrate (CLS) is a mucoactive drug efficacy in the treatment of bronchopulmonary diseases including COPD. The PEACE study showed a reduction of 25% of exacerbations for patients treated with carbocysteine in COPD. However, only 17% of PEACE study patients received background therapy including inhaled steroids (IS).

METHODS: We have performed a prospective real life clinical trial. The criteria include GOLD stage II-IV, FEV1 31%-79% predicted, age 41-79 years. Principal objective is to compare the frequency of >2 exacerbations over a 1-year treatment period with CLS added to background therapy either with or without IS in COPD patients with >1 exacerbation in the previous year.

RESULTS: As of Jun-30, 202 patients were included in the study with a minimum 3-month follow-up and 108 patients completed the 1 year study period. Mean age was 69.8, of these, 67 patients had ≥2 exacerbations at baseline: CLS was added to background therapy including IS in 68.6% and without IS in 58.9%. After 1 year, only 64.2% of these 67 patients experienced ≥2 exacerbations, respectively 58.3% and 67.4% in the group receiving vs. non receiving IS (p=6313, NS). Also the mean number of exacerbations declined significantly, overall from 2.6 to 1.2 (Δ=−53,8%, p<0.0001): significant improvement was seen both in IS (from 2.9 to 1.4, Δ=−51,7%, p=0.0001) and non-IS patients (from 2.4 to 1.1, Δ=−54.2%, p<0.0001), with no significant difference between the 2 groups (p=0.6184).

CONCLUSIONS: The results dimostrate that addition of CLS allows significant reduction of COPD exacerbations in patients with >2 exacerbations at baseline. Our preliminary results further demonstrate the great effectiveness of administration of a single daily dose of CLS (2,7g/die) in reducing exacerbations in COPD patients and support its strong recommendation in clinical practice.

CLINICAL IMPLICATIONS: CLS in patients with > 2 exacerbations at baseline allows significant reduction of COPD exacerbations either if they are in background therapy with or without IS. Reduction of exacerbation could leed to a better quality of life.

DISCLOSURE: Luigi Lanata: Employee: Medical department Federico Saibene: Employee: Medical Department The following authors have nothing to disclose: Gregorino Paone, Barbara Moscatelli, Renato Delli Colli, Augusto Bevilacqua, Giovanni Puglisi

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