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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014408-71-GB

Enrollment

150

Registered

2009-08-17

Start date

2009-10-08

Completion date

Unknown

Last updated

2015-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exacerbations of chronic obstructive pulmonary disease

Interventions

Trade Name: Prednisolone 5mg Product Name: Prednisolone Pharmaceutical Form: Tablet INN or Proposed INN: PREDNISOLONE CAS Number: 50-24-8 Concentration unit: mg milligram(s) Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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. Corticosteroid therapy may be of benefit in only small sub group of patients (COCHRANE review), and have considerable side effects (NNH =6). Primary objectives: 1.Change in number of exacerbations treated with corticosteroids and antibiotics 2.Number of exacerbations associated with treatment failure 3.Change in health status;Secondary Objective: Number of adverse reactions, FEV1;Primary end point(s): 1. Change in number of exacerbations treated with corticosteroids 2. Proportion of exacerbations associated with treatment failure 3. change in health status from stable state to exacerbation	—

Measure

Time frame

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. Corticosteroid therapy may be of benefit in only small sub group of patients (COCHRANE review), and have considerable side effects (NNH =6). Primary objectives: 1.Change in number of exacerbations treated with corticosteroids and antibiotics 2.Number of exacerbations associated with treatment failure 3.Change in health status;Secondary Objective: Number of adverse reactions, FEV1;Primary end point(s): 1. Change in number of exacerbations treated with corticosteroids 2. Proportion of exacerbations associated with treatment failure 3. change in health status from stable state to exacerbation

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026