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

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 14.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2008-008192-34-BE
• Lead Sponsor: EDMOND PHARMA S.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-11
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• 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 0.7L absolute value). Current or past cigarette smokers with a smoking history 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), 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: 0
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 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. Subjects with liver cirrhosis as well as patients with cystathionine-synthetase deficiency. Long term oxygen therapy. Known or suspected hypersensitivity to erdosteine. Participation in another clinical trial with an investigational drug in the 60 days prior to inclusion

Study & Design

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