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Abstract: Poster Presentations |

The Mosaic Study: A New Landmark in the Therapy of Acute Exacerbations of Chronic Bronchitis FREE TO VIEW

Anthony Anzueto, MD; Robert Wilson, MD; Luigi Allegra, MD; Gérard Huchon, MD; Jose-Luis Izquierdo, MD; Paul Jones, MD; Tom Schaberg, MD; Pierre Arvis, MD; Isabelle Duprat-Lomon, MD; Pierre-Phillippe Sagnier, MD
Author and Funding Information

University of Texas, San Antonio, TX


Chest


Chest. 2003;124(4_MeetingAbstracts):134S. doi:10.1378/chest.124.4_MeetingAbstracts.134S-a
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Abstract

PURPOSE:  Using an innovative study design we compared oral moxifloxacin (MXF) 400 mg QD for 5 days with amoxicillin, clarithromycin or cefuroxime-axetil (CMP) at recommended doses for 7 days to treat acute exacerbations of chronic bronchitis (AECB).

METHODS:  This multicenter, double-blind study included outpatients aged > 45 years with stable CB, history of smoking of ≥20 packs/year, ≥2 documented AECB in the previous year, and FEV1 < 85% of predicted value. Patients with Anthonisen type 1 AECB within 12 months of enrolment were randomised. Patients were assessed at screening, end of treatment and 7-10 days after treatment, and contacted monthly until new AECB occurred or up to 9 months. Clinical cure was defined as return to pre-AECB status, and clinical success as cure and improvement combined. Other measures were bacteriological treatment success, need for further antimicrobials and time to next AECB.

RESULTS:  730 ITT patients received MXF (n=354) or CMP (n=376). Cure rates were 70.9% with MXF and 62.8% with CMP in the ITT population (95% CI 1.4, 14.9; p=0.05), and 68.7% vs. 62.1% in the per protocol population (95% CI 0.3, 15.6; p=0.02). Clinical success was seen in 83.0-87.6% of ITT patients across treatment arms and populations with a significant difference in favor of MXF in patients not receiving steroids (p<0.01). In the per protocol population, 91.5% of patients on MXF and 81.0% on CMP showed bacteriological success (95% CI 0.4, 22.1). A significantly lower proportion of patients required additional antimicrobials in the moxifloxacin arm (9.5% vs. 15.1%, p=0.045). Mean times to new AECB in patients not requiring further antibiotics were 132.8 days for MXF and 118.0 days for CMP (p=0.03).CONCLUSIONS: There was a significantly greater response to MXF for cure rates, rates of bacteriological eradication, need for additional antimicrobials and time to next exacerbation.

CLINICAL IMPLICATIONS:  The excellent clinical outcomes for MXF support the use of MXF in AECB and should be considered in future treatment guidelines.DISCLOSURE: A. Anzueto, None.

Wednesday, October 29, 2003

12:30 PM- 2:00 PM


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