Biomarkers to target antibiotics and steroid therapy in chronic obstructive pulmonary disease (COPD) exacerbations

The use of biomarkers to direct antibiotic and systemic corticosteroid therapy in chronic obstructive pulmonary disease (COPD) exacerbations: a randomised controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN92422949

Enrollment

106

Registered

2009-07-30

Start date

2009-09-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Chronic obstructive pulmonary disease (COPD) Respiratory Other chronic obstructive pulmonary disease

Interventions

Current interventions as of 20/10/2009: Randomised 12-month parallel group study with two study groups: 1. Standard care therapy group: subjects will receive treatment as decided by a physician and c

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. Greater than one exacerbation requiring antibiotics and or corticosteroids in the preceding year

Exclusion criteria

Exclusion criteria: 1. Current active respiratory tuberculosis 2. Upon questioning the patient known human immunodeficiency virus (HIV) infection or positive hepatitis B or C 3. Known inability to produce a sputum sample during the induced sputum procedure 4. 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 5. Any clinically relevant lung disease other than COPD 6. Donation of blood within 3 months or during the study (for other than study purpose) 7. Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
1. Proportion of exacerbations treated with antibiotics and corticosteroids 2. Proportion of exacerbations that are associated with a treatment failure 3. Change in health status Looked at within 3 months of the completion of the study. Added 20/10/2009: The study has 80% powering to show equivalence in a minimal change of health status (0.5: measured by the mCRQ).	—

Secondary

Measure	Time frame
1. Change in forced expiratory volume in one second (FEV1) 2. Markers of airway inflammation 3. Number of adverse reactions Looked at within 3 months of the completion of the study.	—

Countries

United Kingdom

Outcome results

None listed

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