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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00656747
Recruitment Status : Completed
First Posted : April 11, 2008
Last Update Posted : December 1, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Chronic Bronchitis Drug: Avelox (Moxifloxacin, BAY12-8039) Drug: Amoxicillin clavulanic acid Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1372 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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.
Study Start Date : March 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Arm 2 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.

Experimental: Arm 1 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.

Primary Outcome Measures :
  1. Clinical failure at 8 weeks post therapy [ Time Frame: At day 63 ]

Secondary Outcome Measures :
  1. Clinical failure rates [ Time Frame: Through to day 35 ]
  2. Bacteriological eradication rates [ Time Frame: Through to day 63 ]
  3. Clinical failure rates for subjects with positive sputum culture at enrollment [ Time Frame: Through to day 63 ]
  4. Weekly mean symptom scores measured by the AECB SS [ Time Frame: Through to day 63 ]
  5. Rates and speed of symptom relief measured by the AECB SS [ Time Frame: Through to day 63 ]
  6. Clinical failure rates for subjects with co-administration of systemic corticosteroids (stratum 1) [ Time Frame: Through to day 63 ]
  7. Clinical failure rates for subjects without co-administration of systemic corticosteroids (stratum 2) [ Time Frame: Through to day 63 ]
  8. 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 ]
  9. Improvement in symptoms burden measured by the AECB SS [ Time Frame: Through to day 63 ]
  10. Improvement in health related QoL measured by the SGRQ [ Time Frame: Through to day 63 ]
  11. spirometry tests will be compared between treatment groups [ Time Frame: Through to day 63 ]
  12. 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 ]
  13. Safety and tolerability of moxifloxacin versus amoxicillin clavulanic acid, with particular attention to rates of diarrhea [ Time Frame: Through to day 63 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00656747

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Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer

Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bayer Identifier: NCT00656747    
Other Study ID Numbers: 11980
2007-006096-37 ( EudraCT Number )
First Posted: April 11, 2008    Key Record Dates
Last Update Posted: December 1, 2014
Last Verified: November 2014
Keywords provided by Bayer:
Chronic Obstructive Pulmonary Disease (COPD)
Acute exacerbation of COPD (AECOPD)
chronic bronchitis
chest infection
lung disease
Additional relevant MeSH terms:
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Bronchitis, Chronic
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Clavulanic Acids
Clavulanic Acid
Amoxicillin-Potassium Clavulanate Combination
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs