Antibiotics for exacerbations of chronic obstructive pulmonary disease: a pilot randomised trial within the General Practice Research Database - Antibiotics for exacerbations of chronic obstructive pulmonary disease

Phase 1

• Conditions: Diagnosed at a GP visit as suffering from acute exacerbation of COPD a.Medical history of COPD b.Increase in dyspnoea AND increase of (non-purulent) sputum volume

• Registration Number: EUCTR2010-019513-24-GB
• Lead Sponsor: ondon School of Hygiene & Tropical Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-07
• Study Completion: 2012-07-12
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

Study inclusion criteria
(i)Age 40 years or older
ii)Diagnosed at a GP visit as suffering from acute exacerbation of COPD
a.Medical history of COPD
b.Increase in dyspnoea and sputum volume
c.Sputum that is non-purulent
iii)Able and willing to provide informed consent to study participation
iv) Subjects who in the opinion of the GP Investigator could be prescribed an antibiotic

Study exclusion criteria
(i)COPD exacerbation in the last 28 days
(ii)Immediate referral to specialist care for treatment of COPD exacerbation
(iii)Prescribed an antibiotic in the previous 3 months
(iv)Contra-indication to antibiotics. Further details can be found in the British National Formulary (section 5)

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

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

Study & Design

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