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

NCT01398072 | Unknown Phase 3

• 1 other identifier: 11/0078
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD).

Outcome Measures

Primary Outcomes (1)

• To measure and compare reduction in the concentration of lower airway bacteria in patients with COPD between three different antibiotic regimes and placebo

  Week 14 post treatment

Secondary Outcomes (1)

• To measure changes in lung function measure, health status and exacerbations.

  week 14 post treatment

Study Arms (4)

Moxifloxacin

ACTIVE COMPARATOR

Drug: Moxifloxacin

Azithromycin

ACTIVE COMPARATOR

Drug: Azithromycin

Doxycycline

ACTIVE COMPARATOR

Drug: Doxycycline

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Moxifloxacin DRUG

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

Moxifloxacin

Azithromycin DRUG

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

Azithromycin

Doxycycline DRUG

An oral dose of 100 mg once daily.

Doxycycline

Placebo DRUG

Oral dose of one table once daily.

Placebo

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead
• Royal Free Hampstead NHS Trust: collaborator
• University of Cambridge: collaborator
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Academic Unit of Respiratory Medicine, Royal Free Hospital

London, NW3 2PF, United Kingdom

RECRUITING

Related Publications (1)

• Brill SE, Law M, El-Emir E, Allinson JP, James P, Maddox V, Donaldson GC, McHugh TD, Cookson WO, Moffatt MF, Nazareth I, Hurst JR, Calverley PM, Sweeting MJ, Wedzicha JA. Effects of different antibiotic classes on airway bacteria in stable COPD using culture and molecular techniques: a randomised controlled trial. Thorax. 2015 Oct;70(10):930-8. doi: 10.1136/thoraxjnl-2015-207194. Epub 2015 Jul 15.

  PMID: 26179246 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Moxifloxacin; Azithromycin; Doxycycline

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Jadwiga A Wedzicha

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ethaar El-Emir, PhD

CONTACT

0044 2073177510; ethaar.el-emir@nhs.net

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 18, 2011
• First Posted: July 20, 2011
• Study Start: December 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: April 1, 2013
• Last Updated: June 1, 2012

Record last verified: 2012-05

Locations

GB (1)