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 placebo.
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 cause of hospital admission in the UK. Bacterial infections play an important role in the development of COPD and so one possible treatment for COPD is with antibiotics. However, there is little information available about the use of long term antibiotics in the treatment of this disease. Therefore, the purpose of this study is to investigate if long term use of the antibiotic Doxycycline can reduce exacerbations and improve the outlook for these patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
222
An oral dose of 100 mg of Doxycycline once daily, for a total duration of 52 weeks.
An oral dose of one capsule of placebo once daily, for a total duration of 52 weeks
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
Rate of exacerbations (per person/year) recorded from date of drug issue until date of end of treatment visit.
Time frame: 12 months
Lung function (spirometry) (FEV1, FVC, FEV1/FVC ratio, FEV1 as % Predicted).
Time frame: 12 months of treatment
Total and individual component (symptoms, activity, impact) SGRQ scores will be used to measure health status.
Time frame: 12 months of treatment
Respiratory health status across groups as measured from total number of symptoms in a day and prevalence of individual symptoms recorded on daily diary cards.
Time frame: 12 months of treatment
Airway bacteria numbers taken from a sputum sample, provided by a subset of patients, at months 3, 6, 9, 12 after drug issue.
Time frame: 12 months of treatment
Changes in C-reactive protein (CRP) levels from baseline.
Time frame: 12 months of treatment
Hospital admissions. This data will be collected from Hospital Episode Statistics (HES).
Time frame: 12 months of treatment
Time to 1st exacerbation measured by diary cards in both therapy and placebo groups.
Time frame: 12 months of treatment
Rate of exacerbations treated with steroids and antibiotics.
Time frame: 12 months of treatment
Adherence as measured using pill counts.
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Time frame: 12 months of treatment
Antibiotic resistance measured in the subset of patients (able to produce sputum) from sputum based on standard NHS procedures (not resistant, intermediate, severe, resistant).
Time frame: 12 months of treatment