Status:
COMPLETED
Targeted Retreatment of COPD Exacerbations
Lead Sponsor:
Imperial College London
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
45+ years
Phase:
PHASE3
Brief Summary
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 rece...
Detailed Description
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 br...
Eligibility Criteria
Inclusion
- Diagnosis of COPD confirmed spirometrically at screening
- COPD exacerbation with treatment commenced 14 days prior to study enrolment and treated with 5-14 days of a non-quinolone antibiotic.
- Exacerbation here will be defined as an episode of symptomatic worsening of COPD that was treated by the patient's attending clinician. Confirmation of the initial exacerbation diagnosis will be provided from the case notes, referral letter, or directly from the treating clinician, and will be documented in the CRF.
- Age: ≥ 45 years of age at screening.
- Persistent symptoms and/or a CRP≥8mg/L when assessed 2 weeks after exacerbation onset
- Able to complete questionnaires for health status and symptoms and keep written diary cards
- Severity of disease: Patients with a measured FEV1\<80% of predicted normal values at 2 weeks post exacerbation
- Able and willing to give signed and dated written informed consent to participate.
Exclusion
- Other clinically predominant chronic respiratory disease.
- Intubated and receiving mechanical ventilation
- Patients with known hypersensitivity to the antibiotic under evaluation, to other quinolones or any excipients of the IMP/placebo.
- Patients with a prior history of tendonopathy or tendon rupture
- Elderly patients taking long term systemic corticosteroids
- Patients on long term antibiotics for other conditions
- Patient too unwell for randomisation, i.e. requiring retreatment in the judgment of the study doctor
- Female patients who are pregnant or planning on becoming pregnant during the study, or are breastfeeding.
- Patient taking clinically significant contraindicated medication as per the SmPC s, such as use of concomitant tizanidine or methotrexate.
Key Trial Info
Start Date :
May 5 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2019
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT02300220
Start Date
May 5 2014
End Date
January 22 2019
Last Update
March 8 2021
Active Locations (4)
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1
Aintree University Hospital NHS Foundation Trust
Liverpool, United Kingdom, L9 7AL
2
St Georges University Hospitals NHS Foundation Trust
London, United Kingdom, SW17 0RE
3
Royal Brompton and Harefield Hospital NHS Foundation Trust
London, United Kingdom, SW36NP
4
St Mary's Hospital
London, United Kingdom, W2 1NY