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

• Status: Unknown status
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London
• Collaborators: National Institute for Health Research, United Kingdom; Royal Free Hampstead NHS Trust; University of Cambridge
• Treatments: Anti-Bacterial Agents; Azithromycin; Doxycycline; Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

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