Evidence map›Paper›PMID 20109213›Full record

Trial reportRespiratory research2010

Pulsed moxifloxacin for the prevention of exacerbations of chronic obstructive pulmonary disease: a randomized controlled trial.

Sanjay Sethi, Paul W Jones, Marlize Schmitt Theron, Marc Miravitlles, Ethan Rubinstein, Jadwiga A Wedzicha, Robert Wilson, PULSE Study group

Erratum issued Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Respiratory research, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00473460 (A Double-blind, Randomized, Placebo-controlled Study to Investigate Chronic Intermittent-pulse-therapy of Moxifloxacin as a Prevention of Acute in Exacerbation Out-patients With Chronic Bronchitis.), which is not on this map. Cited by 60 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 6 pooled it
15.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00473460 phase3completednot on this map

A Double-blind, Randomized, Placebo-controlled Study to Investigate Chronic Intermittent-pulse-therapy of Moxifloxacin as a Prevention of Acute in Exacerbation Out-patients With Chronic Bronchitis.

TypeinterventionalSponsorBayerRan2004 to 2007Enrolled1,404ConditionsLung Diseases, Bronchitis, ChronicArmsAvelox (Moxifloxacin, BAY12-8039), Placebo
3 · Its place in the literature

Who cites it

60 citing papers in PubMed, 6 syntheses or guidelines pooled it, 187 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Antibiotics for exacerbations of chronic obstructive pulmonary disease.The Cochrane database of systematic reviews · 2018
    Pooled it
  5. Guideline
  6. Guidelines for the management of adult lower respiratory tract infections--full version.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2011
    Guideline
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Review
  16. Article
  17. Review
  18. Review
  19. Review
  20. Chronic Obstructive Pulmonary Disease: Lifestyle Impact.International journal of preventive medicine · 2024
    Review
4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

8 authors at 5 institutions in 4 countries.

Sanjay SethiDivision of Pulmonary, Critical Care and Sleep Medicine, University of Buffalo, State University of New York, Buffalo, NY, USA. ssethi@buffalo.edu
Paul W Jones
Marlize Schmitt Theron
Marc Miravitlles
Ethan Rubinstein
Jadwiga A Wedzicha
Robert Wilson
PULSE Study group
Fundació Clínic per a la Recerca Biomèdica · ESSt George's, University of London · GBThe Royal Free Hospital · GBRoyal Brompton Hospital · GBUniversity at Buffalo, State University of New York · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAcute 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.

methodsStable 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.

resultsAt 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%).

conclusionsIntermittent 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 registrationClinicalTrials.gov number, NCT00473460 (ClincalTrials.gov).

Indexed as

AgedAged, 80 and overAnti-Infective AgentsAza CompoundsChronic DiseaseDose-Response Relationship, DrugDouble-Blind MethodFemaleFluoroquinolonesHumansMaleMiddle AgedMoxifloxacinPlacebo EffectPulmonary Disease, Chronic ObstructiveQuinolinesAnti-Infective AgentsAza CompoundsFluoroquinolonesMoxifloxacinQuinolines

Identifiers

PMID20109213
PMCPMC2834642
OpenAlexW2102634938

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.