evalutation of the antitussive effect of Erdosteine in patients with chronic bronchitis

• Conditions: COPD; MedDRA version: 14.1Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-000620-14-IT
• Lead Sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-16
• Last Update Posted: 10 March 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

patients with clinical diagnosis of COPD and chronic bronchitis complaining from chronic cough
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 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

- female of child-bearing potential; - pregnant or breast-feeding women; - lack of efficient contraception; - clinically significant or unstable concurrent disease, such as recent myocardial infarction, unstable coronary artery disease, heart failure NYHA class III IV; - signifcant epatic and renal impairment; - gastrointestinal disease (eg. active peptic ulcere); - other significant comorbidities; - change of the ongoing therapeutic COPD regimen in the last two weeks prior to the study; - known or suspected ipersensitivity to Erdosteine; - partecipation in another clinical study in the preceding sixty days

Study & Design

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