A novel study design for antibiotic trials in acute exacerbations of copd:Maestral methodology

Robert Wilson, Antonio Anzueto, Marc Miravitlles, Pierre Arvis, Geneviève Faragó, Daniel Haverstock, Mila Trajanovic, Sanjay Sethi

Research output: Contribution to journalArticle

9 Scopus citations

Abstract

Antibiotics, along with oral corticosteroids, are standard treatments for acute exacerbations of chronic obstructive pulmonary disease (AECOPD). The ultimate aims of treatment are to minimize the impact of the current exacerbation, and by ensuring complete resolution, reduce the risk of relapse. In the absence of superiority studies of antibiotics in AECOPD, evidence of the relative efficacy of different drugs is lacking, and so it is difficult for physicians to select the most effective antibiotic. This paper describes the protocol and rationale for MAESTRAL (moxifoxacin in AECBs [acute exacerbation of chronic bronchitis] trial; www.clinicaltrials.gov: NCT00656747), one of the frst antibiotic comparator trials designed to show superiority of one antibiotic over another in AECOPD. It is a prospective, multinational, multicenter, randomized, double-blind controlled study of moxifloxacin (400 mg PO [per os] once daily for 5 days) vs amoxicillin/clavulanic acid (875/125 mg PO twice daily for 7 days) in outpatients with COPD and chronic bronchitis suffering from an exacerbation. MAESTRAL uses an innovative primary endpoint of clinical failure: the requirement for additional or alternate treatment for the exacerbation at 8 weeks after the end of antibiotic therapy, powered for superiority. Patients enrolled are those at high-risk of treatment failure, and all are experiencing an Anthonisen type I exacerbation. Patients are stratified according to oral corticosteroid use to control their effect across antibiotic treatment arms. Secondary endpoints include quality of life, symptom assessments and health care resource use. This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.

Original languageEnglish (US)
Pages (from-to)373-383
Number of pages11
JournalInternational Journal of COPD
Volume6
Issue number1
DOIs
StatePublished - Dec 1 2011

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Keywords

  • AECOPD
  • Amoxicillin/clavulanic acid
  • Antibiotic
  • Clinical trial design
  • Exacerbation
  • Moxifloxacin

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Health Policy
  • Public Health, Environmental and Occupational Health

Cite this

Wilson, R., Anzueto, A., Miravitlles, M., Arvis, P., Faragó, G., Haverstock, D., Trajanovic, M., & Sethi, S. (2011). A novel study design for antibiotic trials in acute exacerbations of copd:Maestral methodology. International Journal of COPD, 6(1), 373-383. https://doi.org/10.2147/COPD.S21071