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.

Elegibilidad

Edad mínima: 60 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Avelox (Moxifloxacin, BAY12-8039)

Subjects will be randomised to moxifloxacin 400 mg PO OD (5 days). Subjects will also take placebo tablets, so that each subject takes 3 tablets per day for 7 days. Prior to randomization, subjects are stratified based on co-administration of short-course systemic steroids.

drug

Amoxicillin clavulanic acid

Subjects will be randomised to amoxicillin-clavulanic acid 875/125 mg PO BID (7 days). Subjects will also take placebo tablets, so that each subject takes 3 tablets per day for 7 days. Prior to randomization, subjects are stratified based on co-administration of short-course systemic steroids.

Ubicaciones

Quilmes, Buenos Aires, Argentina

San Juan Bautista, Buenos Aires, Argentina

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

San Miguel de Tucumán, Tucumán Province, Argentina

Vicente López, Argentina

MAESTRAL - A Prospective, Multinational, Multicenter, Randomized, Double Blind, Double Dummy, Controlled Study Comparing the Efficacy and Safety of Moxifloxacin to That of Amoxicillin Clavulanic Acid for the Treatment of Subjects With Acute Exacerbations of Chronic Bronchitis.

Resumen