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

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ClinicalTrials.gov Identifier: NCT01398072
Recruitment Status : Unknown
Verified May 2012 by University College, London.
Recruitment status was:  Recruiting
First Posted : July 20, 2011
Last Update Posted : June 1, 2012
Royal Free Hampstead NHS Trust
University of Cambridge
National Institute for Health Research, United Kingdom
Information provided by:
University College, London

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD). Drug: Moxifloxacin Drug: Azithromycin Drug: Doxycycline Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: A Phase III Single-blind, Randomised Placebo Controlled Trial of Long Term Therapy in Patients With Stable COPD Using Moxifloxacin, Azithromycin and Doxycycline: a Bayesian Decision Analysis, Including Other Criteria, Will be Used to Distinguish the Optimal Antibiotic Treatment
Study Start Date : December 2011
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : April 2013

Arm Intervention/treatment
Active Comparator: Moxifloxacin Drug: Moxifloxacin
An oral dose of 400 mg once daily for 5 consecutive days every 4 weeks.

Active Comparator: Azithromycin Drug: Azithromycin
An oral dose of 250 mg once daily three times a week (every other day).

Active Comparator: Doxycycline Drug: Doxycycline
An oral dose of 100 mg once daily.

Placebo Comparator: Placebo Drug: Placebo
Oral dose of one table once daily.

Primary Outcome Measures :
  1. To measure and compare reduction in the concentration of lower airway bacteria in patients with COPD between three different antibiotic regimes and placebo [ Time Frame: Week 14 post treatment ]

Secondary Outcome Measures :
  1. To measure changes in lung function measure, health status and exacerbations. [ Time Frame: week 14 post treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Confirmed COPD diagnosis
  • Informed Consent: Patients must give their signed and dated written informed consent to participate
  • Gender: Male or female patients
  • Age: ≥ 45 years of age at screening
  • Produce sputum regularly (produce sputum in at least 3 months of a year)
  • Able to complete questionnaires for health status and symptoms and considered able to comply with the dosing regimen.
  • Severity of disease: Patients with a measured FEV1<80% of predicted normal values as determined at screening. An average of three spirometry readings will be taken.

Exclusion Criteria:

  • Patients with TB, other chronic respiratory disease (e.g. chronic asthma, bronchiectasis, pulmonary fibrosis), patients with hepatic or renal impairment and patients with prolonged QT interval and other cardiac abnormalities.
  • Patients with known hypersensitivity to the antibiotics under evaluation.
  • Patients on long term antibiotics for other conditions.
  • Patients with uncontrolled hypertension.
  • Female patients who are pregnant or planning on becoming pregnant during the study, or are breastfeeding.
  • Patients with a history of long QT syndrome or whose QTc measured at Visit 1 is prolonged (>450 msec for males and females) as confirmed by the ECG assessor.
  • Clinically relevant abnormal laboratory values at the screening assessment that could interfere with the objectives of the trial or safety of the volunteer.
  • Patient taking clinically significant contraindicated medication, as per the SmPCs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01398072

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Contact: Ethaar El-Emir, PhD 0044 2073177510 ethaar.el-emir@nhs.net

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United Kingdom
Academic Unit of Respiratory Medicine, Royal Free Hospital Recruiting
London, United Kingdom, NW3 2PF
Contact: Ethaar El-Emir, PhD    0044 2073177510    ethaar.el-emir@nhs.net   
Principal Investigator: Jadwiga A Wedzicha, MA, MD, FRCP         
Sponsors and Collaborators
University College, London
Royal Free Hampstead NHS Trust
University of Cambridge
National Institute for Health Research, United Kingdom
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Principal Investigator: Jadwiga A Wedzicha University College, London
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alison Evans, University College London
ClinicalTrials.gov Identifier: NCT01398072    
Other Study ID Numbers: 11/0078
First Posted: July 20, 2011    Key Record Dates
Last Update Posted: June 1, 2012
Last Verified: May 2012
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Chronic Disease
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents