Moxifloxacin Versus Amoxicillin Clavulanic Acid in Treatment of Acute Exacerbation of Chronic Bronchitis

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