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 language | English (US) |
|---|---|
| Pages (from-to) | 373-383 |
| Number of pages | 11 |
| Journal | International Journal of COPD |
| Volume | 6 |
| Issue number | 1 |
| DOIs | |
| State | Published - 2011 |
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Keywords
- AECOPD
- Amoxicillin/clavulanic acid
- Antibiotic
- Clinical trial design
- Exacerbation
- Moxifloxacin
ASJC Scopus subject areas
- Pulmonary and Respiratory Medicine
- Public Health, Environmental and Occupational Health
- Health Policy
- Medicine(all)
Cite this
A novel study design for antibiotic trials in acute exacerbations of copd : Maestral methodology. / Wilson, Robert; Anzueto, Antonio R; Miravitlles, Marc; Arvis, Pierre; Faragó, Geneviève; Haverstock, Daniel; Trajanovic, Mila; Sethi, Sanjay.
In: International Journal of COPD, Vol. 6, No. 1, 2011, p. 373-383.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A novel study design for antibiotic trials in acute exacerbations of copd
T2 - Maestral methodology
AU - Wilson, Robert
AU - Anzueto, Antonio R
AU - Miravitlles, Marc
AU - Arvis, Pierre
AU - Faragó, Geneviève
AU - Haverstock, Daniel
AU - Trajanovic, Mila
AU - Sethi, Sanjay
PY - 2011
Y1 - 2011
N2 - 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.
AB - 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.
KW - AECOPD
KW - Amoxicillin/clavulanic acid
KW - Antibiotic
KW - Clinical trial design
KW - Exacerbation
KW - Moxifloxacin
UR - http://www.scopus.com/inward/record.url?scp=81055123895&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=81055123895&partnerID=8YFLogxK
U2 - 10.2147/COPD.S21071
DO - 10.2147/COPD.S21071
M3 - Article
VL - 6
SP - 373
EP - 383
JO - International Journal of COPD
JF - International Journal of COPD
SN - 1176-9106
IS - 1
ER -