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
|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 ]
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 email@example.com|
|Academic Unit of Respiratory Medicine, Royal Free Hospital||Recruiting|
|London, United Kingdom, NW3 2PF|
|Contact: Ethaar El-Emir, PhD 0044 2073177510 firstname.lastname@example.org|
|Principal Investigator: Jadwiga A Wedzicha, MA, MD, FRCP|
|Principal Investigator:||Jadwiga A Wedzicha||University College, London|