An investigation into the mechanisms of action of a combined long acting beta agonist/inhaled corticosteroid (Seretide 500 accuhaler) on the bacterial colonisation, immunology and inflammation of patients with Chronic Obstructive Pulmonary Disease (COPD)

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: EUCTR2009-015876-86-GB
• Lead Sponsor: Southampton University Hospitals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-29
• Last Update Posted: 12 November 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

COPD will be defined as forced expiratory volume in one second (FEV1) of <80% predicted for age and height, and salbutamol reversibility of <400 ml with airflow obstruction evidenced by a ratio of FEV1 to forced vital capacity (FVC) of <70%. A minimum of a 10 pack year history in all groups. Healthy smokers will be subjects who have smoked a minimum of 10 pack years but have normal lung function, they will be matched in all other criteria to the COPD patients. Mild, moderate and severe patients will be defined by FEV1. Mild >50-80% Moderate >30%-50% Severe <30% The COPD patients are to have never used components present in the Seretide (Salmeterol and flixotide)
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 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Patients with a history of asthma, bronchiectasis, carcinoma of the bronchus, or other significant respiratory disease will be excluded. A comprehensive history, chest x-ray and reversibility studies performed on this cohort will be used to identify those with other lung pathology. Patients will also be excluded if they have exacerbated during the last 6 weeks. Patients will also be excluded if they have been prescribed inhaled corticosteroids for the treatment of their condition.

Study & Design

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