The effectiveness of antibiotics compared to no antibiotics for exacerbations of chronic obstructive pulmonary disease: a feasibility study

Not Applicable

Completed

Conditions: Chronic obstructive pulmonary disease
Respiratory
Other chronic obstructive pulmonary disease

Registration Number: ISRCTN72035428

Lead Sponsor: ondon School of Hygiene and Tropical Medicine (LSHTM) (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 150

Inclusion Criteria

1. Aged 40 years or older, either sex
2. Diagnosed at a GP visit as suffering from acute exacerbation of COPD:
2.1. Medical history of COPD
2.2. Increase in dyspnoea and increase of (non-purulent) sputum volume
3. Able and willing to provide informed consent to study participation
4. Fully registered with the general practice for at least 6 months (i.e. subjects who are newly registered with the practice will not be eligible)
5. Subjects who had not been prescribed an antibiotic in the previous 3 months
6. Subjects who in the opinion of the GP Investigator could be prescribed an antibiotic

Exclusion Criteria

1. Purulent sputum (as determined by GP)
2. COPD exacerbation in the last 28 days
3. Immediate referral to specialist care for treatment of COPD exacerbation
4. Prescribed an antibiotic in the previous 3 months
5. Contra-indication to antibiotics. Further details can be found in the British National Formulary (section 5).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measuring the feasibility of conducting RCTdb; after randomisation to treatment or no treatment, patients will be followed using information collected in GPRD. The feasibility evaluation will include the recruitment rate and an assessment of the technical challenges in conducting RCTdb. No formal threshold for success will be applied but results will be published.

Secondary Outcome Measures

Name	Time	Method
Over the first four weeks:<br>1. Participants will be requested to complete a daily diary (i.e. the Exacerbations of Chronic Pulmonary Disease Tool: a validated assessment tool to quantify the frequency, severity and duration of COPD exacerbations)<br>2. Repeat GP visit for symptoms related to the same COPD exacerbation in the 4-week period<br>3. Referrals to community respiratory team in the 4-week period<br>4. Hospital admission for COPD exacerbation in the 4-week period<br>5. Prescribing of oral corticosteroids in the 4-week period<br><br>Over 3 months:<br>6. Hospital admission for COPD exacerbation<br>7. All-cause mortality<br>8. Prescribing of antibiotics<br>9. Suspected adverse drug reactions to the study drug<br>10. NHS costs for secondary outcomes<br><br>Given the small number of participants in this study, these secondary outcomes will serve as pilot data for power calculations for larger studies in the future. The study will not be powered statistically to detect a difference in secondary outcomes.