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