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: MAESTRAL (moxifloxacin in AECB superiority trial) - MAESTRA

Conditions: acute exacerbation of chronic bronchitis
MedDRA version: 9.1Level: LLTClassification code 10000743Term: Acute exacerbation of chronic bronchitis

Registration Number: EUCTR2007-006096-37-DE

Lead Sponsor: Bayer HealthCare AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1786

Inclusion Criteria

1.Outpatients with chronic bronchitis
2.Male or female subjects, greater than or equal to 60 years old
3.Subject who can be managed with oral antimicrobials
4.Post bronchodilatory FEV1 less than or equal to 60% predicted and FEV1/FVC less than 70% at enrollment.
5.Documented history of 2 or more AECB episodes, within 12 months of study enrollment, requiring a course of systemic antibiotics and/or systemic corticosteroids 6.All symptoms/signs must be present and confirmed by the Investigator: •Increase in dyspnea •Purulent sputum •Increase in sputum volume
7.Subject must provide a sputum. The sputum will be assessed macroscopically by the investigator and should be graded as either yellow, green or rust (according to the provided color chart).
8.Current or past cigarette smoker with great than or equal to 20 pack year smoking history
9.Subjects must be exacerbation-free at least 30 days prior to enrollment 10.Subjects must be willing and able to complete the questionnaires and subject booklet without assistance
11.Subjects with medical conditions and social status at the time of enrollment compatible with study protocol procedures
12.Willing and able to provide written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Known hypersensitivity to quinolones, ß-lactams, or to any of the excipients of the study drugs
2. Pregnant or breast feeding women (women of childbearing potential, based on investigator assessment must have negative urinary pregnancy test)
3.Known to have congenital or acquired QT prolongation
4.Known to have clinically relevant bradycardia
5.Known to have clinically relevant heart failure with reduced left ventricular ejection fraction
6.Known to have previous history of symptomatic arrhythmias
7.Taking QT prolonging drugs, for example class IA or III antiarrhythmic agents (e.g., quinidine, procainamide, amiodarone, sotalol), neuroleptics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressants, certain antihistaminics (e.g., terfenadine, astemizole, mizolastine), certain antimicrobials (sparfloxin, erythromycin IV, pentamidine, antimalarials particularly halofantrine) or other QT prolonging drugs (e.g., cisapride, vincamine iv, bepridil, and diphemanil)
8.Known electrolyte disturbances that are not controlled, particularly uncorrected hypokalemia
9.Known history of hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose galactose malabsorption
10.History of a tendon disease/disorder
11.Known history of liver dysfunction (Child-Pugh C), including known elevated transaminases (ALT and/or AST greater than 5 times the upper limit of normal)
12.Known severe renal impairment with glomerular filtration rate of <30mL/min
13.Known neutropenia (neutrophil count <1000/mm3) caused by immunosuppressive therapy or malignancy
14.Known to have AIDS (CD4 count of <200/mm3), or be HIV positive and receiving Highly Active Anti Retroviral Therapy (HAART) (HIV testing is not mandatory)
15.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)
16.Known history of chronic colonization of pathogenic organisms resistant to moxifloxacin and/or amoxicillin clavulanic acid (e.g., Pseudomonas aeruginosa, MRSA)
17.Receiving long term (>4 consecutive weeks) systemic corticosteroid treatment (>10 mg/day of prednisolone or equivalent)
18.Received short course of systemic corticosteroid treatment within 30 days prior to enrollment
19.Unable to take oral medication
20.Life expectancy of less than 6 months
21.Receiving systemic antibacterial therapy within 30 days prior to study enrollment
22.Requiring concomitant systemic antibacterial agents
23.Use of any investigational drug or device within 30 days of screening, or previously enrolled in this study
24.Requiring home ventilatory support (subjects requiring home/portable oxygen therapy or CPAP for sleep apnea are not excluded) and/or those who have a tracheotomy in situ
25.History of liver function disorders following previous treatment with amoxicillin-clavulanic acid
26. Receiving disulfiram therapy