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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00656747
• Date of registration: 04/04/2008
• Prospective Registration: No
• Primary sponsor: Bayer
• Public title: Moxifloxacin Versus Amoxicillin Clavulanic Acid in Treatment of Acute Exacerbation of Chronic Bronchitis
• Scientific title: 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.
• Date of first enrolment: March 2008
• Target sample size: 1372
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00656747
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Andorra, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Indonesia, Ireland, Italy, Latvia, Lithuania, Mexico, Netherlands, Pakistan, Peru, Philippines, Portugal, South Africa, Spain, Switzerland, Thailand, United Kingdom

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

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



Age minimum: 60 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Bronchitis

Intervention(s)

Drug: Avelox (Moxifloxacin, BAY12-8039)

Drug: Amoxicillin clavulanic acid

Primary Outcome(s)

Clinical failure at 8 weeks post therapy [Time Frame: At day 63]

Secondary Outcome(s)

Clinical failure rates for subjects with positive sputum culture at enrollment [Time Frame: Through to day 63]

Improvement in health related QoL measured by the SGRQ [Time Frame: Through to day 63]

Improvement in symptoms burden measured by the AECB SS [Time Frame: Through to day 63]

Need for any change in dosage or additional respiratory medication such as bronchodilators and inhaled steroids, excluding short acting bronchodilators [Time Frame: Through to day 63]

Safety and tolerability of moxifloxacin versus amoxicillin clavulanic acid, with particular attention to rates of diarrhea [Time Frame: Through to day 63]

Rates and speed of symptom relief measured by the AECB SS [Time Frame: Through to day 63]

Bacteriological eradication rates [Time Frame: Through to day 63]

Weekly mean symptom scores measured by the AECB SS [Time Frame: Through to day 63]

Clinical failure rates [Time Frame: Through to day 35]

Clinical failure rates for subjects with co-administration of systemic corticosteroids (stratum 1) [Time Frame: Through to day 63]

Clinical failure rates for subjects without co-administration of systemic corticosteroids (stratum 2) [Time Frame: Through to day 63]

HCRU relat. to chronic bronchitis management incl. rescue med., concomitant med., therap. adjuncts, diagn. procedures, other medical care/medical staff requirement, hospitalizations (incl. ward and duration), and work productivity and activity impairment [Time Frame: Through to day 63]

spirometry tests will be compared between treatment groups [Time Frame: Through to day 63]

Secondary ID(s)

2007-006096-37

11980

Source(s) of Monetary Support

Please refer to primary and secondary sponsors