Moxifloxacin Versus Amoxicillin Clavulanic Acid in Treatment of Acute Exacerbation of Chronic Bronchitis
NCT ID: NCT00656747
Last Updated: 2014-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1372 participants
INTERVENTIONAL
2008-03-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm 2
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.
Arm 1
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
60 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Les Escaldes, , Andorra
Quilmes, Buenos Aires, Argentina
San Juan Bautista, Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
San Miguel de Tucumán, Tucumán Province, Argentina
San Miguel de Tucumán, Tucumán Province, Argentina
Vicente López, , Argentina
Concord, New South Wales, Australia
Brisbane, Queensland, Australia
Adelaide, South Australia, Australia
Woodville, South Australia, Australia
Nedlands, Western Australia, Australia
Aalst, , Belgium
Antwerp, , Belgium
Bruxelles - Brussel, , Belgium
Halen, , Belgium
Lommel, , Belgium
Moerkerke, , Belgium
Namur, , Belgium
Yvoir, , Belgium
Juiz de Fora, Minas Gerais, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Edmonton, Alberta, Canada
Kelowna, British Columbia, Canada
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Winnipeg, Manitoba, Canada
Saint John, New Brunswick, Canada
Saint John, New Brunswick, Canada
Antigonish, Nova Scotia, Canada
Sydney Mines, Nova Scotia, Canada
Burlington, Ontario, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Longueuil, Quebec, Canada
Montreal, Quebec, Canada
Sherbrooke, Quebec, Canada
Santiago, , Chile
Valparaíso, , Chile
Viña del Mar, , Chile
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Changsha, Hunan, China
Shengyang, Liaoning, China
Shenyang, Liaoning, China
Chengdu, Sichuan, China
Beijing, , China
Beijing, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Tianjin, , China
Cali, Cauca Department, Colombia
Bogotá, , Colombia
Bucaramanga, , Colombia
Cali, , Colombia
Medellín, , Colombia
Osijek, , Croatia
Petrinja, , Croatia
Rijeka, , Croatia
Zagreb, , Croatia
Kyjov, , Czechia
Lovosice, , Czechia
Neratovice, , Czechia
Pardubice - Trnova, , Czechia
Praha - Malesice, , Czechia
Praha - Troja, , Czechia
Marseille, , France
Mont-de-Marsan, , France
Nice, , France
Perpignan, , France
Bad Dürrheim, Baden-Wurttemberg, Germany
Augsburg, Bavaria, Germany
Cottbus, Brandenburg, Germany
Rüdersdorf, Brandenburg, Germany
Zossen, Brandenburg, Germany
Hamburg, City state of Hamburg, Germany
Hamburg, City state of Hamburg, Germany
Frankfurt am Main, Hesse, Germany
Frankfurt am Main, Hesse, Germany
Fulda, Hesse, Germany
Neubrandenburg, Mecklenburg-Vorpommern, Germany
Lüdenscheid, North Rhine-Westphalia, Germany
Neuwied, Rhineland-Palatinate, Germany
Böhlen, Saxony, Germany
Delitzsch, Saxony, Germany
Dresden, Saxony, Germany
Leipzig, Saxony, Germany
Leipzig, Saxony, Germany
Leipzig, Saxony, Germany
Meissen, Saxony, Germany
Bad Segeberg, Schleswig-Holstein, Germany
Lübeck, Schleswig-Holstein, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Athens, Attica, Greece
Mezourlo, Larissa, Greece
Rio, Patras, Greece
Athens, , Greece
Ioannina, , Greece
Hong Kong, , Hong Kong
Kowloon, , Hong Kong
Bandung, , Indonesia
Jakarta, , Indonesia
Surabaya, , Indonesia
Killarney, Kerry, Ireland
Longford, Longford, Ireland
Enniscorthy, Wexford, Ireland
Gorey, Wexford, Ireland
Bray, Wicklow, Ireland
Pregiato Di Cava Dei Tirreni, Salerno, Italy
Busto Arsizio, Varese, Italy
Bussolengo, Verona, Italy
Ascoli Piceno, , Italy
Catania, , Italy
Chieti, , Italy
Milan, , Italy
Milan, , Italy
Perugia, , Italy
Krāslava, , Latvia
Riga, , Latvia
Riga, , Latvia
Riga, , Latvia
Talsu, , Latvia
Valmiera, , Latvia
Ventspils, , Latvia
Kaunas, , Lithuania
Kaunas, , Lithuania
Klaipėda, , Lithuania
Šiauliai, , Lithuania
Vilnius, , Lithuania
Vilnius, , Lithuania
Chihuahua City, Chihuahua, Mexico
Guadalajara, Jalisco, Mexico
Monterrey, Nuevo León, Mexico
Monterrey, Nuevo León, Mexico
Huixquilucan, State of Mexico, Mexico
Mérida, Yucatán, Mexico
Zacatecas City, Zacatecas, Mexico
Eindhoven, North Brabant, Netherlands
Heerlen, , Netherlands
Hoofddorp, , Netherlands
Meppel, , Netherlands
Utrecht, , Netherlands
Karachi, Sindh, Pakistan
Islamabad, , Pakistan
Karachi, , Pakistan
Lima, Lima Province, Peru
Callao, , Peru
Lima, , Peru
Lima, , Peru
Lima, , Peru
Lima, , Peru
Manila, , Philippines
Quezon City, , Philippines
Coimbra, Coimbra District, Portugal
Torres Vedras, Lisbon District, Portugal
Matosinhos Municipality, Porto District, Portugal
Vila Nova de Gaia, Porto District, Portugal
Lisbon, , Portugal
Lisbon, , Portugal
Porto, , Portugal
S. Martinho Do Bispo, , Portugal
Santarém, , Portugal
Port Elizabeth, Eastern Cape, South Africa
Bloemfontein, Freestate, South Africa
Benoni, Gauteng, South Africa
Centurion, Gauteng, South Africa
Kempton Park, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Durban, KwaZulu-Natal, South Africa
Durban, KwaZulu-Natal, South Africa
Thabazimbi, Limpopo, South Africa
Witbank, Mpumalanga, South Africa
Cape Town, Western Cape, South Africa
Paarl, Western Cape, South Africa
Somerset West, Western Cape, South Africa
Badalona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Sant Boi de Llobregat, Barcelona, Spain
Guadalajara, Guadalajara, Spain
Palma de Mallorca, Illes Baleares, Spain
Madrid, Madrid, Spain
Requena, Valencia, Spain
Laufen, Basel-Landschaft, Switzerland
Oberwil, Basel-Landschaft, Switzerland
Aarau, Canton of Aargau, Switzerland
Binningen, Canton of Basel-City, Switzerland
Bern, Canton of Bern, Switzerland
Zurich, Canton of Zurich, Switzerland
Zurich, Canton of Zurich, Switzerland
Basel, , Switzerland
Thun, , Switzerland
Wettingen, , Switzerland
Chiang Mai, Thailand, Thailand
Bangkok, , Thailand
Nonthaburi, , Thailand
Glasgow, Stratchclyde, United Kingdom
Glasgow, Stratchclyde, United Kingdom
Glasgow, Stratchclyde, United Kingdom
Glasgow, Stratchclyde, United Kingdom
Glasgow, Stratchclyde, United Kingdom
Coventry, Warwickshire, United Kingdom
Countries
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References
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Wilson R, Anzueto A, Miravitlles M, Arvis P, Farago G, Haverstock D, Trajanovic M, Sethi S. A novel study design for antibiotic trials in acute exacerbations of COPD: MAESTRAL methodology. Int J Chron Obstruct Pulmon Dis. 2011;6:373-83. doi: 10.2147/COPD.S21071. Epub 2011 Jun 29.
Wilson R, Anzueto A, Miravitlles M, Arvis P, Haverstock D, Trajanovic M, Sethi S. Prognostic factors for clinical failure of exacerbations in elderly outpatients with moderate-to-severe COPD. Int J Chron Obstruct Pulmon Dis. 2015 Jun 2;10:985-93. doi: 10.2147/COPD.S80926. eCollection 2015.
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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2007-006096-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
11980
Identifier Type: -
Identifier Source: org_study_id