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Effects of Long Term Antibiotic Therapy on Exacerbation Rate in Stable COPD Patients | Clinical Trials | Clareo Health

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Effects of Long Term Antibiotic Therapy on Exacerbation Rate in Stable COPD Patients

A Phase III Double-blind, Randomised, Placebo Controlled Trial of Long Term Therapy on Exacerbation Rate in Patients With Stable COPD Using Doxycycline

NCT02305940•Imperial College London

View on ClinicalTrials.gov

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 placebo.

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 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.

Eligibility

Age

45 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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.
+1 more criteria

Locations (3)

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

Key Dates

Start Date

July 1, 2014

Primary Completion Date

July 12, 2017

Completion Date

July 12, 2017

Last Updated

July 26, 2017

Enrollment

222

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Doxycycline

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 26, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effects of Long Term Antibiotic Therapy on Exacerbation Rate in Stable COPD Patients

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

Mindful-Breath for People With COPD

The HELlenic Thoracic Society Initiative for CΟPD and CVD

Magnetic Stimulation of Diaphragm in Chronic Obstructive Pulmonary Disease

COPD Exacerbation Modelling Using Unobtrusive Sensors - the TOLIFE Clinical Study A