This study investigates the effects of targeted re-treatment of patients who do not recover from an exacerbation of COPD. Half of the patients will receive ciprofloxacin while the other half will receive a placebo.
COPD is a long term lung condition where patients suffer recurrent symptom flare-ups, called 'exacerbations'. Patients who have lots of exacerbations have a worse quality of life, poorer ability to breath, and may die earlier than those who don't. Previous research by our group has shown that patients who have an exacerbation and have not completely recovered two weeks after the start of treatment are more likely to suffer another one early than those who completely recover. This study aims to test whether we can prevent this early re-exacerbation by giving an extra course of antibiotics, compared to a placebo. Patients who experience an exacerbation of COPD and are treated with antibiotics will, two weeks after the start of their treatment, be invited to attend a screening visit. Patients will be eligible for the study if they have not fully recovered at this visit (i.e. if they either still have symptoms or if blood tests show there is still inflammation present) and fulfil other diagnostic measures for COPD. Patients will be allocated to the treatment groups at random, and if eligible will be treated with a further 1 week of ciprofloxacin 500mg twice daily or a placebo. Patients will then be followed up in the study for a further 3 months, and the primary study outcome will be the time to the next exacerbation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
144
500 mg, twice daily for 1 week (oral)
One capsule, twice daily for 1 week
Aintree University Hospital NHS Foundation Trust
Liverpool, United Kingdom
St Georges University Hospitals NHS Foundation Trust
London, United Kingdom
Royal Brompton and Harefield Hospital NHS Foundation Trust
London, United Kingdom
St Mary's Hospital
London, United Kingdom
Time to the Next COPD Exacerbation
The primary outcome will be the time to the next COPD exacerbation following targeted retreatment with the IMP or placebo, censored at 90 days.
Time frame: Up to 90 days
Duration of the Initial Exacerbation
Secondary endpoints will include duration of the initial exacerbation following targeted retreatment with the IMP or placebo.
Time frame: Up to 90 days
Number of Participants With Serious Non Fatal Adverse Events
Secondary endpoints will include adverse events following targeted retreatment with the IMP or placebo.
Time frame: 7 days of treatment
Changes in Lung Function
Secondary endpoints will include changes from randomization to 90 days in FEV1.
Time frame: Baseline and 90 days
Number of Participants Who Have Resistance Bacteria in the Sputum
Bacterial load and resistance Secondary endpoints will include resistance following targeted retreatment with the IMP or placebo.
Time frame: Up to 90 days
Hospital Readmission
Secondary endpoints will include hospital readmission following targeted retreatment with the IMP or placebo.
Time frame: 90 days of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.