Study RESTORE

• Research type

  Research Study

• Full title

  The efficacy and safety of erdosteine in the long-term therapy of chronic obstructive pulmonary disease (COPD). A 12-month, randomised, double-blind, placebo-controlled, parallel group, multicenter study.

• IRAS ID

  21101

• Contact name

  Lisa Davies

• Sponsor organisation

  Edmond Pharma

• Eudract number

  2008-008192-34

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a 12-month study performed to evaluate the efficacy of erdosteine as add-on treatment in patients with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD).Erdosteine is a mucolytic agent that can reduce the viscosity of phlegm (mucus) in the airways. Erdosteine is used to treat the symptoms of respiratory diseases. The main objective of this study is to demonstrate that erdosteine can reduce the risk of acute exacerbations in these patients. Moreover, the effects of erdosteine on clinical symptoms and quality of life, pulmonary function and exercise performance will be assessed.More than 500 outpatients of both sexes, aged from 40 to 80 years, with a clinical diagnosis of moderate-to-severe COPD will be enrolled. Patients should have experienced at least 2 acute COPD exacerbations in the 12 months prior to enrolment and should not have had any other recent changes in their COPD medication. Any concomitant treatment for COPD ongoing at the time of patient??s enrolment (e.g. bronchodilators, inhaled corticosteroids, theophylline) is allowed. Other mucolytic agents (e.g. carbocysteine) or cough suppressants (e.g. codeine), alone or in combination with other drugs, are not allowed.Patients will be treated with erdosteine 300 mg b.i.d. or matching placebo for 12 months. Clinical visits will be performed before and after 1, 3, 6, 9 and 12 months of treatment for the evaluation of the efficacy and safety of the drug.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  09/H0402/75

• Date of REC Opinion

  10 Jul 2009

• REC opinion

  Further Information Favourable Opinion