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. - Study RESTORE
- Conditions
- Chronic Obstructive Pulmonary DiseaseMedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD
- Registration Number
- EUCTR2008-008192-34-GB
- Lead Sponsor
- Edmond Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 467
- Outpatients of both sexes, aged between 40 and 80 years - Diagnosis of COPD (Stage II and III according to GOLD 2007) as follows: post-bronchodilator FEV1/FVC <70%, FEV1 between 30-70% predicted (and at least 0.7 L absolute value) - Current or past cigarette smokers with an history of smoking of at least 10 pack-years - On a stable therapeutic regimen for COPD for at least 8 weeks prior to inclusion - Having experienced at least 2 acute exacerbations of COPD within 2-12 months prior to inclusion - Presence of chronic COPD symptoms (cough, sputum production, dyspnoea) - Having a mean cough and sputum score (derived from BCSS) of at least 1.5 for each symptom during run-in - Willing and able to comply with study procedures - 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
- Female subjects: pregnant, lactating mother or lack of efficient contraception in a subject with child-bearing potential - Acute exacerbation of COPD, antibiotic/systemic steroids treatment and/or hospitalisations within 8 weeks prior to inclusion - Change of the therapeutic regimen for COPD in the last 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 - Subjects with liver cirrhosis as well as patients with cystathionine-synthetase deficiency are excluded from participating in the study due to the possible interference of erdosteine metabolites with methionine metabolism, in line with contraindications reported in SmPC - 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 principal objective of the study is to evaluate if erdosteine is effective in reducing the risk of acute exacerbations in patients affected by moderate-to-severe COPD during a 12-month treatment period.;Secondary Objective: Secondary objectives of the study will be to investigate the effects of erdosteine on chronic respiratory symptoms and quality of life, pulmonary function and exercise performance, and disease-related costs. Moreover, the safety and tolerability of the drug during long-term administration will be assessed.;Primary end point(s): The primary outcome measure for the study is the number of acute exacerbations of COPD experienced by the patients in the two groups during the 12-month treatment period. Acute COPD exacerbations are defined as a symptomatic worsening requiring treatment with antibiotics, systemic corticosteroids, or both. Exacerbations will be reviewed by the Steering Committee before statistical analysis.
- Secondary Outcome Measures
Name Time Method