Pulsed moxifloxacin for the prevention of exacerbations of chronic obstructive pulmonary disease: a randomized controlled trial
| dc.contributor.author | Sethi, Sanjay | |
| dc.contributor.author | Jones, Paul W | |
| dc.contributor.author | Theron, Marlize S | |
| dc.contributor.author | Miravitlles, Marc | |
| dc.contributor.author | Rubinstein, Ethan | |
| dc.contributor.author | Wedzicha, Jadwiga A | |
| dc.contributor.author | Wilson, Robert | |
| dc.contributor.author | the PULSE Study group | |
| dc.date.accessioned | 2013-05-10T15:10:08Z | |
| dc.date.available | 2013-05-10T15:10:08Z | |
| dc.date.issued | 2010-01-28 | |
| dc.date.updated | 2013-05-10T15:10:08Z | |
| dc.description.abstract | Abstract Background Acute exacerbations contribute to the morbidity and mortality associated with chronic obstructive pulmonary disease (COPD). This proof-of-concept study evaluates whether intermittent pulsed moxifloxacin treatment could reduce the frequency of these exacerbations. Methods Stable patients with COPD were randomized in a double-blind, placebo-controlled trial to receive moxifloxacin 400 mg PO once daily (N = 573) or placebo (N = 584) once a day for 5 days. Treatment was repeated every 8 weeks for a total of six courses. Patients were repeatedly assessed clinically and microbiologically during the 48-week treatment period, and for a further 24 weeks' follow-up. Results At 48 weeks the odds ratio (OR) for suffering an exacerbation favoured moxifloxacin: per-protocol (PP) population (N = 738, OR 0.75, 95% confidence interval (CI) 0.565-0.994, p = 0.046), intent-to-treat (ITT) population (N = 1149, OR 0.81, 95% CI 0.645-1.008, p = 0.059), and a post-hoc analysis of per-protocol (PP) patients with purulent/mucopurulent sputum production at baseline (N = 323, OR 0.55, 95% CI 0.36-0.84, p = 0.006). There were no significant differences between moxifloxacin and placebo in any pre-specified efficacy subgroup analyses or in hospitalization rates, mortality rates, lung function or changes in St George's Respiratory Questionnaire (SGRQ) total scores. There was, however, a significant difference in favour of moxifloxacin in the SGRQ symptom domain (ITT: -8.2 vs -3.8, p = 0.009; PP: -8.8 vs -4.4, p = 0.006). Moxifloxacin treatment was not associated with consistent changes in moxifloxacin susceptibility. There were more treatment-emergent, drug related adverse events with moxifloxacin vs placebo (p < 0.001) largely due to gastrointestinal events (4.7% vs 0.7%). Conclusions Intermittent pulsed therapy with moxifloxacin reduced the odds of exacerbation by 20% in the ITT population, by 25% among the PP population and by 45% in PP patients with purulent/mucopurulent sputum at baseline. There were no unexpected adverse events and there was no evidence of resistance development. Trial registration ClinicalTrials.gov number, NCT00473460 (ClincalTrials.gov). | |
| dc.description.version | Peer Reviewed | |
| dc.identifier.citation | Respiratory Research. 2010 Jan 28;11(1):10 | |
| dc.identifier.doi | http://dx.doi.org/10.1186/1465-9921-11-10 | |
| dc.identifier.uri | http://hdl.handle.net/1993/20387 | |
| dc.language.rfc3066 | en | |
| dc.rights | open access | en_US |
| dc.rights.holder | Sanjay Sethi et al.; licensee BioMed Central Ltd. | |
| dc.title | Pulsed moxifloxacin for the prevention of exacerbations of chronic obstructive pulmonary disease: a randomized controlled trial | |
| dc.type | Journal Article |
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