![]() ![]() Known history of liver dysfunction (Child-Pugh C), including known elevated transaminase levels (alanine aminotransferase and/or aspartate aminotransferase >5 times the upper limit of normal ).Known history of hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose galactose malabsorption.Known electrolyte disturbances that are not controlled, particularly uncorrected hypokalemia.Taking QT prolonging drugs, for example Class Ia or III antiarrhythmic agents or other QT prolonging drugs.Known to have previous history of symptomatic arrhythmias.Known to have clinically relevant heart failure with reduced left ventricular ejection fraction.Known to have clinically relevant bradycardia.Known to have congenital or acquired QT prolongation.Known hypersensitivity to quinolones, ß lactams, or to any of the excipients of the study drugs.Subjects must be willing and able to complete the questionnaires and subject booklet without assistance.Subjects must be exacerbation free for at least 30 days prior to enrollment.Current or past cigarette smoker with equal to or greater than 20 pack year smoking history.Documented history of 2 or more AECB episodes, within 12 months of study enrollment, requiring a course of systemic antibiotics and/or systemic corticosteroidsĪll symptoms/signs must be present and confirmed by the Investigator:.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.Male or female subjects, >=60 years old.Safety and tolerability of moxifloxacin versus amoxicillin clavulanic acid, with particular attention to rates of diarrhea.ward and duration), and work productivity and activity impairment ![]() procedures, other medical care/medical staff requirement, hospitalizations (incl. spirometry tests will be compared between treatment groups.Improvement in health related QoL measured by the SGRQ.Improvement in symptoms burden measured by the AECB SS.Need for any change in dosage or additional respiratory medication such as bronchodilators and inhaled steroids, excluding short acting bronchodilators.Clinical failure rates for subjects without co-administration of systemic corticosteroids (stratum 2).Clinical failure rates for subjects with co-administration of systemic corticosteroids (stratum 1).Rates and speed of symptom relief measured by the AECB SS.Weekly mean symptom scores measured by the AECB SS.Clinical failure rates for subjects with positive sputum culture at enrollment.Why Should I Register and Submit Results?.
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