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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00656747
First received: April 4, 2008
Last updated: November 17, 2014
Last verified: November 2014
  Purpose

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 Intervention Phase
Chronic Bronchitis
Drug: Avelox (Moxifloxacin, BAY12-8039)
Drug: Amoxicillin clavulanic acid
Phase 4

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
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.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Clinical failure at 8 weeks post therapy [ Time Frame: At day 63 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical failure rates [ Time Frame: Through to day 35 ] [ Designated as safety issue: No ]
  • Bacteriological eradication rates [ Time Frame: Through to day 63 ] [ Designated as safety issue: No ]
  • Clinical failure rates for subjects with positive sputum culture at enrollment [ Time Frame: Through to day 63 ] [ Designated as safety issue: No ]
  • Weekly mean symptom scores measured by the AECB SS [ Time Frame: Through to day 63 ] [ Designated as safety issue: No ]
  • Rates and speed of symptom relief measured by the AECB SS [ Time Frame: Through to day 63 ] [ Designated as safety issue: No ]
  • Clinical failure rates for subjects with co-administration of systemic corticosteroids (stratum 1) [ Time Frame: Through to day 63 ] [ Designated as safety issue: No ]
  • Clinical failure rates for subjects without co-administration of systemic corticosteroids (stratum 2) [ Time Frame: Through to day 63 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Improvement in symptoms burden measured by the AECB SS [ Time Frame: Through to day 63 ] [ Designated as safety issue: No ]
  • Improvement in health related QoL measured by the SGRQ [ Time Frame: Through to day 63 ] [ Designated as safety issue: No ]
  • spirometry tests will be compared between treatment groups [ Time Frame: Through to day 63 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Safety and tolerability of moxifloxacin versus amoxicillin clavulanic acid, with particular attention to rates of diarrhea [ Time Frame: Through to day 63 ] [ Designated as safety issue: Yes ]

Enrollment: 1372
Study Start Date: March 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656747

  Show 221 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Medical Affairs Therapeutic Area Head, Bayer HealthCare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00656747     History of Changes
Other Study ID Numbers: 11980, 2007-006096-37
Study First Received: April 4, 2008
Last Updated: November 17, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Andorra: Ethics Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Canada: Health Canada
Chile: Comisión Nacional de Investigación Científica y Tecnológica
China: Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Croatia: Ministry of Health
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ministry of Health and Welfare
Hong Kong: Department of Health
Indonesia: National Agency of Drug and Food Control
Ireland: Irish Medicines Board
Italy: Ethics Committee
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Mexico: Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Pakistan: Ministry of Health
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Philippines: Bureau of Food and Drugs
Portugal: National Pharmacy and Medicines Institute
South Africa: Department of Health
South Africa: Medicines Control Council
Spain: Ministry of Health
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic
Thailand: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Bayer:
Chronic Obstructive Pulmonary Disease (COPD)
Acute exacerbation of COPD (AECOPD)
chronic bronchitis
bronchitis
chest infection
smoking
lung disease
lung
lungs

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Pulmonary Disease, Chronic Obstructive
Acute Disease
Bronchial Diseases
Disease Attributes
Lung Diseases
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acid
Clavulanic Acids
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014