Please use this identifier to cite or link to this item:
https://hdl.handle.net/2440/97553
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Type: | Journal article |
Title: | A double-blind, randomised, placebo-controlled study of roxithromycin and doxycycline combination, roxithromycin alone, or matching placebo for 12 weeks in adults with frequent exacerbations of chronic obstructive pulmonary disease |
Author: | Shafuddin, E. Mills, G. Holmes, M. Poole, P. Mullins, P. Black, P. |
Citation: | Journal of Negative Results in Biomedicine, 2015; 14(1):15-15 |
Publisher: | Springer Science and Business Media LLC |
Issue Date: | 2015 |
ISSN: | 1477-5751 |
Statement of Responsibility: | Eskandarain Shafuddin, Graham D. Mills, Mark D. Holmes, Phillippa J. Poole, Peter R. Mullins, and Peter N. Black |
Abstract: | Azithromycin prophylaxis has been shown to reduce COPD exacerbations but there is poor evidence for other antibiotics. We compared exacerbation rates in COPD patients with a history of frequent exacerbations (at least three moderate or severe COPD exacerbations in the past two years) during a 12-week treatment course and over a subsequent 48-week follow up period.292 patients were randomised to one of three treatments for 12 weeks: roxithromycin 300 mg daily and doxycycline 100 mg daily (n = 101); roxithromycin 300 mg daily (n = 97); or matching placebos (n = 94). There were no differences in the annualised moderate and severe exacerbation rates after treatment with roxithromycin/doxycycline (2.83 (95 % CI 2.37-3.40)) or roxithromycin only (2.69 (2.26-3.21)) compared to placebo (2.5 (2.08-3.03)) (p = 0.352 and p = 0.5832 respectively). Furthermore, there were no differences in the annualised exacerbation rates during 12-week treatment with roxithromycin/doxycycline (1.64 (95 % CI 1.17-2.30)), roxithromycin only (1.75 (1.24-2.41)) or placebo (2.23 (1.68-3.03)) (p = 0.1709 and p = 0.2545 respectively). There were also no significant differences between groups for spirometry or quality of life scores over either the 12-week treatment or 48-week post-treatment periods. Both active treatments were associated with nausea but otherwise adverse events were comparable among treatment groups.Twelve-weeks of prophylaxis with roxithromycin/doxycycline combination or roxithromycin alone did not reduce COPD exacerbations in patients with history of frequent exacerbations. These findings do not support the use of these antibiotics to prevent exacerbations in COPD patients. |
Keywords: | Humans Pulmonary Disease, Chronic Obstructive Disease Progression Roxithromycin Doxycycline Drug Therapy, Combination Double-Blind Method Aged Middle Aged Female Male |
Rights: | © 2015 Shafuddin et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
DOI: | 10.1186/s12952-015-0034-8 |
Published version: | http://dx.doi.org/10.1186/s12952-015-0034-8 |
Appears in Collections: | Aurora harvest 3 Medicine publications |
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hdl_97553.pdf | Published version | 728.55 kB | Adobe PDF | View/Open |
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