Background Information of the Condition
Chronic bronchitis is a subset of chronic obstructive pulmonary disease defined by a productive cough for at least 3 months in duration in each of 2 consecutive years, which may include an acute exacerbation of increased sputum production and purulence, and increased dyspnea. An increased respiratory rate and wheezing, lethargy and elevated temperature are usually indicative of an acute exacerbation of chronic bronchitis, which is usually caused by a virus. Measurement of expiratory flow volume is recommended along with oxygen saturation in moderate to severe cases, whereas sputum cultures are not routinely recommended.1
Drug (Product Monograph)2, 3
Category: Moxifloxacin is a member of the fluoroquinolone class of antibiotics.
Mechanism of Action: Moxifloxacin exerts its action by inhibiting the bacterial topoisomerases II (DNA gyrase) and topoisomerases IV, which interferes with bacterial DNA replication, transcription, repair, and recombination.
Indications: Moxifloxacin is indicated for the treatment of adults with upper and lower respiratory tract, skin/skin structure, and intra-abdominal infections.
Dose & Duration: The recommended dose is 400mg i.v./oral once daily for 5 days.
Methodology of Systematic Review
In double blind randomized controlled trials (DB RCTs), does moxifloxacin provide a significant therapeutic advantage in terms of mortality or morbidity when compared to other fluoroquinolones or other classes of antibacterial agents in the treatment of adult patients with acute exacerbations of chronic bronchitis?
Assessment principles: Double blind randomized controlled trials comparing moxifloxacin to other fluoroquinolones or other classes of antibacterial agents in adult patients with acute exacerbations of chronic bronchitis were critically appraised. Therapeutic impact was assessed according to the following hierarchy of health outcomes – mortality, non-fatal serious adverse events, quality of life, withdrawals due to adverse events, clinical response rates (clinical resolution of signs and symptoms of infection), microbiological response rates (bacteriological eradication of causative pathogen), and other adverse events (e.g. allergic reactions).
Search strategy: Databases searched: Medline, EMBASE and Cochrane Library (from 1966 to February 2008); the manufacturer’s submission, and references of review articles. Key search words included: “moxifloxacin”, “fluoroquinolones,” or “Avelox,” “randomized controlled trial,” and “acute exacerbations of chronic bronchitis.”
Search Findings: Five double blind RCTs met the inclusion criteria, comparing moxifloxacin to levofloxacin, azithromycin, or amoxicillin/clarithromycin/cefuroxime-axetil (Urueta-Robledo et al 2006, Hautamaki et al 2001, Zervos et al 2007, Talib et al 2002, and Wilson et al 2004).4-8
Moxifloxacin versus other fluoroquinolones
Based on two DBRCTs in 1161 adult patients with acute exacerbations of chronic bronchitis, oral moxifloxacin 400mg daily for 5 days was not significantly different from oral levofloxacin 500mg daily for 7 days (Urueta-Robledo et al 2006, Hautamaki et al 2001)4, 5 in terms of mortality, clinical or bacteriological response, total withdrawals, or withdrawals due to adverse events. Hautamaki et al showed no significant differences between treatment groups in terms of non-fatal serious adverse events. Urueta-Robledo et al did not report non-fatal serious adverse events and total adverse events. Hautamaki et al did not report total adverse events.
Moxifloxacin versus other classes of antibacterial agents
Results were based on two DBRCTs in 389 patients (Zervos et al 2007 and Talib et al 2002).6, 7 In the Zervos et al trial which included older patients, oral moxifloxacin 400mg daily for 5 days was not significantly different from oral azithromycin 500mg daily for 3 days in terms of clinical response, however the rate of bacteriological eradication at the end of the study was significantly higher in the moxifloxacin group (ARR = 18% , NNT = 6).6 Mortality, non-fatal serious adverse events, total adverse events, and withdrawals due to adverse events were not reported.
In the Talib et al trial, oral moxifloxacin 400mg daily for 5 days was not significantly different from oral azithromycin 500mg for 1 day then 250mg daily for 4 days in terms of mortality, non-fatal serious adverse events, total withdrawals or withdrawals due to adverse events.7 Clinical response was rated according to changes in severity of cough, cough frequency, wheezing, and dyspnea from baseline to day 3 or 7 of therapy, all of which improved significantly with moxifloxacin compared to azithromycin.7 Bacteriological response was not reported.
Based on one DBRCT in 733 patients ≥ 45 years of age (Wilson et al 2004)8, oral moxifloxacin 400mg daily for 5 days was not significantly different from other oral comparator drugs (including oral amoxicillin 500mg daily t.i.d. for 7 days, clarithromycin 500mg b.i.d. for 7 days or cefuroxime-axetil 250mg b.i.d. for 7 days) in terms of mortality, non-fatal serious adverse events, clinical or bacteriological response, total withdrawals or withdrawals due to adverse events. The clinical success rate (cure + improvement) 7-10 days after the end of therapy was not significantly different, however the bacteriological success rate at this interval was significantly improved in patients receiving moxifloxacin (ARR = 11%, NNT = 10).8 Total adverse events were not reported.
In double blind randomized controlled trials, moxifloxacin does not differ significantly compared to other fluoroquinolones or other classes of antibiotics in clinically relevant outcomes for the treatment of adult patients with acute exacerbations of chronic bronchitis.
- Guideline for the Diagnosis and Management of: Acute Exacerbation of Chronic Bronchitis (2001). Alberta Clinical Practice Guidelines by the Alberta Medical Association.
- Product Monograph: Moxifloxacin hydrochloride (Avelox®). Antibacterial Agent. Bayer Inc., Feb. 15, 2007.
- eCPS (electronic Compendium of Pharmaceuticals and Specialties), Mar. 2008
- Urueta-Robledo, J., Ariza, H., Jardim, J.R., Caballero, A. et al. Moxifloxacin versus levofloxacin against acute exacerbations of chronic bronchitis: the latin American cohort. Respiratory Medicine, 100: 1504-1511, 2006.
- Hautamaki, D., Bruya, T., Kureishi, A., Warner, J. et al. Short-course (5-day) moxifloxacin versus 7-day levofloxacin therapy for treatment of acute exacerbations of chronic bronchitis. Today’s Therapeutic Trends, 19(2): 117-136, 2001.
- Zervos, M., Martinez, F.J., Amsden, G.W., Rothermel, C.D. et al. Efficacy and safety of 3-day azithromycin versus 5-day moxifloxacin for the treatment of acute bacterial exacerbations of chronic bronchitis. International Journal of Antimicrobial Agents, 29: 56-61, 2007.
- Talib, S.H., Arshad, M., Chauhan, H., Jain, R. et al. Phase III clinical trial of moxifloxacin hydrochloride in the treatment of acute exacerbations of chronic bronchitis in comparison with azithromycin. Journal, Indian Academy of Clinical Medicine, 3(4): 360-366, 2002.
- Wilson, R., Allegra, L., Huchon, G., Izquierdo, J-L. et al. Short-term and long-term outcomes of moxifloxacin compared to standard antibiotic treatment in acute exacerbations of chronic bronchitis. Chest, 125: 953-964, 2004.