moxifloxacin versus amoxicillin clavulanic acid in treatment of acute exacerbation of chronic bronchitis

Conditions: Chronic Bronchitis

Summary: a study to assess the safety and efficacy of moxifloxacin compared to that of amoxicillin-clavulanic acid for the treatment of subjects with acute exacerbation of chronic bronchitis.


Eligibility criteria:
inclusion criteria: * outpatients with chronic bronchitis * male or female subjects, \>=60 years old * post bronchodilator forced expiratory volume in one second (fev1) less than or equal to 60% predicted and fev1 / forced vital capacity (fvc) less than 70% at enrollment * documented history of 2 or more aecb episodes, within 12 months of study enrollment, requiring a course of systemic antibiotics and/or systemic corticosteroids * all symptoms/signs must be present and confirmed by the investigator: * increase in dyspnea * purulent sputum * increase in sputum volume * current or past cigarette smoker with equal to or greater than 20 pack year smoking history * subjects must be exacerbation free for at least 30 days prior to enrollment * subjects must be willing and able to complete the questionnaires and subject booklet without assistance exclusion criteria: * known hypersensitivity to quinolones, ß lactams, or to any of the excipients of the study drugs * known to have congenital or acquired qt prolongation * known to have clinically relevant bradycardia * known to have clinically relevant heart failure with reduced left ventricular ejection fraction * known to have previous history of symptomatic arrhythmias * taking qt prolonging drugs, for example class ia or iii antiarrhythmic agents or other qt prolonging drugs * known electrolyte disturbances that are not controlled, particularly uncorrected hypokalemia * known history of hereditary problems of galactose intolerance, the lapp lactase deficiency, or glucose galactose malabsorption * history of a tendon disease/disorder * known history of liver dysfunction (child-pugh c), including known elevated transaminase levels (alanine aminotransferase \[alt\] and/or aspartate aminotransferase \[ast\] \>5 times the upper limit of normal \[5 x uln\]) * known severe renal impairment with glomerular filtration rate of \<30 ml/min * known neutropenia (neutrophil count \<1000/mm3) caused by immunosuppressive therapy or malignancy * known to have acquired immunodeficiency syndrome (aids) (cd4 count of \<200/mm3), or be human immunodeficiency virus (hiv) positive and receiving highly active anti retroviral therapy (haart) (testing for hiv is not mandatory) * known chronic asthma (\>15% reversibility or at least 200 ml), bronchial carcinoma, active pulmonary tuberculosis, known diffuse bronchiectasis, cystic fibrosis, or pneumonia (a chest x ray is not mandatory) * known history of chronic colonization of pathogenic organisms resistant to moxifloxacin and/or amoxicillin clavulanic acid (eg, p. aeruginosa, methicillin resistant staphylococcus aureus) * receiving long term (\>4 consecutive weeks) systemic corticosteroid treatment (\>10 mg/day of prednisolone or equivalent) * received short course of systemic corticosteroid treatment within 30 days prior to enrollment * life expectancy of less than 6 months * receiving systemic antibacterial therapy within 30 days prior to study enrollment * requiring concomitant systemic antibacterial agents * requiring home ventilatory support (subjects requiring home/portable oxygen therapy or continuous positive airway pressure (cpap) for sleep apnea are not excluded) and/or those who have a tracheotomy in situ * history of liver function disorders following previous treatment with amoxicillin-clavulanic acid * receiving disulfiram therapy

Keywords: chronic obstructive pulmonary disease (copd) acute exacerbation of copd (aecopd) chronic bronchitis bronchitis chest infection smoking lung disease lung lungs