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Development of an Optimal Antibiotic Regime for Long-term Therapy in Stable Chronic Obstructive Pulmonary Disease (COPD)

NCT01398072 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2012-06-01

No results posted yet for this study

Summary

Chronic Obstructive Pulmonary Disease (COPD) is the cause of considerable deaths, and exacerbations (flare up of symptoms) are a major cause of hospital admission in the UK. Bacterial infections play an important role in the development of COPD, 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 identify the best antibiotic regime for treating patients with COPD who have persistent bacterial infection in their lung. We will test a variety of approaches including both older and newer regimes prescribed either on a daily basis at a lower dose or in "pulsed" courses (for example, every other day or five days every month). The three antibiotics tested in this study are: moxifloxacin, azithromycin and doxycycline. This is a 13 weeks study conducted at the Royal Free Hospital, London. It is expected that approximately 200 patients will be selected for this study. The information we get from this study may help us to treat future patients with COPD better.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD).

Interventions

DRUG

Moxifloxacin

An oral dose of 400 mg once daily for 5 consecutive days every 4 weeks.

DRUG

Azithromycin

An oral dose of 250 mg once daily three times a week (every other day).

DRUG

Doxycycline

An oral dose of 100 mg once daily.

DRUG

Placebo

Oral dose of one table once daily.

Sponsors & Collaborators

  • Royal Free Hampstead NHS Trust

    collaborator OTHER

  • University of Cambridge

    collaborator OTHER

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • University College, London

    lead OTHER

Principal Investigators

  • Jadwiga A Wedzicha · University College, London

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-01-31
Completion
2013-04-30

Countries

  • United Kingdom

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01398072 on ClinicalTrials.gov