Status:
COMPLETED
Effects of Long Term Antibiotic Therapy on Exacerbation Rate in Stable COPD Patients
Lead Sponsor:
Imperial College London
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
45+ years
Phase:
PHASE3
Brief Summary
This study investigates if long term use of the antibiotic doxycycline can reduce exacerbations in COPD patients. Half of the patients will receive doxycycline which the other half will receive a plac...
Detailed Description
Chronic Obstructive Pulmonary Disease (COPD) is a common disease which can place a considerable burden on people who suffer from it. COPD exacerbations (periods when symptoms flare up) are a major cau...
Eligibility Criteria
Inclusion
- Informed consent given
- Confirmed COPD diagnosis
- Severity of disease: Patients with a measured FEV1\<80% of predicted normal values.
- At least one treated exacerbation (Patient recalls an episode of symptomatic worsening which was treated and was consistent with a COPD exacerbation) in the previous year.
- Age: ≥ 45 years of age at screening.
- Able to complete questionnaires for health status and symptoms and considered able to comply with the dosing regimen.
- Patients willing to report exacerbations and attend for study visits.
Exclusion
- Patients with a known diagnosis of active TB or other chronic respiratory disease in the judgement of the study doctor.
- Hepatic or renal impairment as defined as LFTs \> 5XULN, and eGFR\<30 ml/min/1.73m2.
- Patients with known hypersensitivity to Tetracyclines, the IMP and/or Placebo including their excipients.
- Patients taking ongoing antibiotic therapy for COPD or other conditions.
- Patients with uncontrolled clinically significant hypertension
- Female patients who are pregnant or planning on becoming pregnant during the study, or are breastfeeding.
- Patients with uncontrolled clinically relevant bradycardia, cardiac arrhythmias or cardiac insufficiency.
- Clinically relevant abnormal electrolyes (sodium or potassium), renal function (urea and creatinine) or liver function (ALT, AST, ALP) that could interfere with the objectives of the trial or safety of the volunteer.
- Patient taking clinically significant contraindicated medication, as per the SmPC for Doxycycline.
- Use of another experimental investigational medicinal product within 3 months of study enrolment. If the IMP used was as part of the NIHR WP2 study then entry to WP3 after a 6 week washout period is permissible.
- Patients with any other condition precluding enrolment in the trial, according to the assessment of the study doctor. This will be documented at screening
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2017
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT02305940
Start Date
July 1 2014
End Date
July 12 2017
Last Update
July 26 2017
Active Locations (3)
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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