Status:
UNKNOWN
Development of an Optimal Antibiotic Regime for Long-term Therapy in Stable Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
University College, London
Collaborating Sponsors:
Royal Free Hampstead NHS Trust
University of Cambridge
Conditions:
Chronic Obstructive Pulmonary Disease (COPD).
Eligibility:
All Genders
45-80 years
Phase:
PHASE3
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 ...
Detailed Description
This is a 14 week study in which 200 patients with COPD will be selected for this study from GP practices up to a 15 mile radius from the Royal Free Hospital to participate in this study. The 3 antibi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2013
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01398072
Start Date
December 1 2011
End Date
April 1 2013
Last Update
June 1 2012
Active Locations (1)
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1
Academic Unit of Respiratory Medicine, Royal Free Hospital
London, United Kingdom, NW3 2PF