Status:
COMPLETED
Moxifloxacin Versus Amoxicillin Clavulanic Acid in Treatment of Acute Exacerbation of Chronic Bronchitis
Lead Sponsor:
Bayer
Conditions:
Chronic Bronchitis
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief 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
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
1372 Patients enrolled
Trial Details
Trial ID
NCT00656747
Start Date
March 1 2008
End Date
December 1 2010
Last Update
December 1 2014
Active Locations (220)
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1
Les Escaldes, Andorra
2
Quilmes, Buenos Aires, Argentina
3
San Juan Bautista, Buenos Aires, Argentina
4
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, 1426