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
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|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease (COPD).||Drug: Moxifloxacin Drug: Azithromycin Drug: Doxycycline Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Active Comparator: Moxifloxacin||
An oral dose of 400 mg once daily for 5 consecutive days every 4 weeks.
|Active Comparator: Azithromycin||
An oral dose of 250 mg once daily three times a week (every other day).
|Active Comparator: Doxycycline||
An oral dose of 100 mg once daily.
|Placebo Comparator: Placebo||
Oral dose of one table once daily.
- 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 ]
- To measure changes in lung function measure, health status and exacerbations. [ Time Frame: week 14 post treatment ]
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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|
- 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.
- 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
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
|Contact: Ethaar El-Emir, PhD||0044 firstname.lastname@example.org|
|Academic Unit of Respiratory Medicine, Royal Free Hospital||Recruiting|
|London, United Kingdom, NW3 2PF|
|Contact: Ethaar El-Emir, PhD 0044 2073177510 email@example.com|
|Principal Investigator: Jadwiga A Wedzicha, MA, MD, FRCP|
|Principal Investigator:||Jadwiga A Wedzicha||University College, London|
|Responsible Party:||Alison Evans, University College London|
|Other Study ID Numbers:||
|First Posted:||July 20, 2011 Key Record Dates|
|Last Update Posted:||June 1, 2012|
|Last Verified:||May 2012|
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
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