THE EFFICACY AND SAFETY OF ERDOSTEINE IN THE LONG-TERM THERAPY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). A 12-month, randomized, double-blind, placebo-controlled, parallel group, multicenter study. - The RESTORE study

• Conditions: MedDRA version: 9.1Level: LLTClassification code 10029978; Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 9.1Level: SOCClassification code 10038738

• Registration Number: EUCTR2008-008192-34-IT
• Lead Sponsor: EDMOND PHARMA S.R.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-03
• Last Update Posted: 30 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 542

Inclusion Criteria

Outpatients of both sexes, aged between 40 and 80 years, current or past cigarette smokers with an history of smoking of at least 10 pack-years. Diagnosis of COPD (Stage II and III according to GOLD 2007), with post-bronchodilator FEV1/FVC <70% and FEV1 between 30% and 70% pred. On a stable therapeutic regimen for COPD for at least 8 weeks prior to inclusion, and having experienced at least 2 acute exacerbations of COPD requiring medical intervention in the previous year. Presence of chronic COPD symptoms (cough, sputum production, dyspnoea), and a mean cough and sputum score (from BCSS) of at least 1.5 for ech symptom during run-in. Written informed consent to participate.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Female subjects: pregnant, lactating mother or lack of efficient contraception in a subject with child-bearing potential. Acute exacerbation of COPD within 8 weeks prior to inclusion. Treatment with antibiotics and/or systemic steroids and/or hospitalisation within 8 weeks prior to inclusion. COPD stage IV. Current or past diagnosis of asthma. Clinically significant or unstable concurrent disease, including significant pulmonary disease (e.g. tuberculosis, cystic fibrosis, bronchiectasis, lung cancer). Significant renal impairment as indicated by creatinine clearance < 25 ml/min. Active peptic ulcer. Long term oxygen therapy. Known or suspected hypersensitivity to erdosteine. Participation in another clinical trial with an investigational drug within 60 days prior to inclusion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to evaluate the efficacy of erdosteine, compared to placebo, in reducing the number of acute exacerbations over a 12-month treatment period in patients with moderate-to-severe COPD;Secondary Objective: Secondary objectives of the study will be to investigate the effects of erdosteine on chronic respiratory symptoms and health-related quality of life, pulmonary function parameters and exercise performance at the 6MWT. In addition, a pharmaco-economy evaluation of disease-related costs will be performed. The study will also evaluate the safety and tolerability of a long-term treatment with erdosteine.;Primary end point(s): The number of acute exacerbations of COPD experienced by the patients in the two groups during the 12-month treatment period.