Biomarkers to target antibiotic and systemic corticosteroid therapy in COPD exacerbations - Biomarkers in COPD exacerbations

Conditions: Exacerbations of chronic obstructive pulmonary disease

Registration Number: EUCTR2009-014408-71-GB

Lead Sponsor: HL NHS Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

1.Provision of informed consent.
2.Male or female.
3.Aged 40 years or over.
4.Diagnosis of COPD.
5.Current or previous smokers

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.Current active respiratory tuberculosis.
2.Upon questioning the patient known HIV infection or positive hepatitis B or C.
3.Clinically relevant disease or disorder (past or present) which in the opinion of the investigator may either put the subject at risk because of participating in the study or may influence the results of the study or the subject’s ability to participate in the study.
4.Any clinically relevant lung disease other than COPD.
5.Pregnancy or lactation.
6.Participation in another clinical study taking investigational products within 3 months of Visit 1
7. Current Diagnosis of cancer.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Subjects will be randomised at exacerbation to receive standard therapy (steroids and or antibiotics) or targeted therapy (based on biomarkers). In the targeted therapy arm, subjects will enter a double blinded placebo controlled intervention; where they will recieve prednisolone or placebo and/or antibiotics as clinically indicated.<br><br>Corticosteroid therapy may be of benefit in only small sub group of patients (COCHRANE review), and have considerable side effects (NNH =6). <br><br>Primary objectives: <br>1.Change in number of exacerbations treated with corticosteroids and antibiotics<br>2.Number of exacerbations associated with treatment failure<br>3.Change in health status;Secondary Objective: Number of adverse reactions,<br>FEV1;Primary end point(s): 1. Change in number of exacerbations treated with corticosteroids<br>2. Proportion of exacerbations associated with treatment failure<br>3. change in health status from stable state to exacerbation

Secondary Outcome Measures