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

Bayer

Status and phase

Completed

Phase 4

Conditions

Chronic Bronchitis

Treatments

Drug: Amoxicillin clavulanic acid

Drug: Avelox (Moxifloxacin, BAY12-8039)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00656747

11980

2007-006096-37 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

1,372 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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