The evaluation of efficacy and safety of erdosteine, a mucolytic anti-oxidant drug, in Chronic Bronchitis with Airway Obstructio

Conditions: Chronic Obstructive Pulmonary Disease
MedDRA version: 14.1Level: PTClassification code 10009033Term: Chronic obstructive pulmonary diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2008-008192-34-BG

Lead Sponsor: Edmond Pharma S.r.l.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 542

Inclusion Criteria

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% and 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 requiring medical intervention within 2-12 months prior to inclusion. Presence of chronic COPD symptoms (cough, sputum production, dyspnoea), and a mean cough and sputum score (derived from BCSS) of at least 1.5 for each 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 220
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 342

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 hospitalisations 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, bronchiectasis, cystic fibrosis, 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 due to the possible interference of erdosteine metabolites with methionine metabolism. 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.