The Efficacy and Safety of Erdosteine in Chronic Obstructive Pulmonary Disease (COPD)

Summary

The aim of the study is to evaluate the effect of erdosteine, compared to placebo, on exacerbation rate over a 12-month treatment period in patients with moderate-to-severe COPD. Moreover, the effects of erdosteine on pulmonary function parameters, clinical symptoms and quality of life, and the long-term safety of the drug will be assessed.

Timeline

Start

2009-08

Primary completion

2014-03

Completion

2015-09

Outcome

Met primary endpoint

paper erdosteine reduced the exacerbation rate by 19.4% (0.91 versus 1.13 exacerbations·patient-1·year-1 for erdosteine and placebo, respectively; p=0.01) PMID 29025888 ↗

Publications

• Dal Negro RW, Wedzicha JA, Iversen M, Fontana G, Page C, Cicero AF, Pozzi E, Calverley PMA; RESTORE group; RESTORE study. Effect of erdosteine on the rate and duration of COPD exacerbations: the RESTORE study. Eur Respir J. 2017 Oct 12;50(4):1700711. doi: 10.1183/13993003.00711-2017. Print 2017 Oct.

Drugs

Indications