Effect of Erdosteine on inflammatory and oxidative biomarkers in sputum and exhaled breath in patients with COPD - Effect of Erdosteine ion lung inflammation and oxidation in COPD

Phase 1

• Conditions: Chronic obstructive pulmonary disease (COPD) of different severity; MedDRA version: 8.1 Level: LLT Classification code 10009033 Term: Chronic obstructive pulmonary disease

• Registration Number: EUCTR2006-005534-20-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-11-29
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

1.COPD patients with FEV1/FVC <70% predicted defined as either stage moderate and severe diagnosis according to GOLD criteria (Global Strategy for the Diagnosis, Management, and Prevention of COPD)
2.Current (an active smoker with a pack history of >10 pack years) and ex-smokers
3.Patients will be allowed to use their current bronchodilators (anticholinergics and long-acting ß2-agonists) and continued on their current dose of inhaled corticosteroids
4.Aged 38 - 80 years inclusive
5.Body mass index within the range 19-32 kg/m2 inclusive
6.FEV1 <15% reversibility (not % pred) after inhaled ß2-agonists (200 µg salbutamol)
7.Stable COPD (no chest infection requiring antibiotics and/or oral steroids in the past 2 months)
8.Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form
9.Available to complete the study

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

1.For female subjects of childbearing potential: pregnant or breast-feeding women, or lack of efficient contraception (i.e. contraceptive methods other than oral contraceptives, IUD, tubal ligature)
2.As a result of the medical interview, physical examination or screening investigations, the Physician Responsible considers the volunteer unfit for the study
3.The subject regularly, or on average, drinks more than 21 units of alcohol per week
4.The subject has received antibiotics and/or oral steroids within 2 months of study entry

5.The subject has been hospitalised for a COPD exacerbation within 2 months of study entry

Study & Design

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