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

NCT00656747 | Completed Phase 4 DMC

• 2 other identifiers: 119802007-006096-37
• Study Type: interventional
• Target: 1,372
• Locations: 31 countries
• Sites: 220

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.

Conditions

Chronic Bronchitis

Keywords

Chronic Obstructive Pulmonary Disease (COPD); Acute exacerbation of COPD (AECOPD); chronic bronchitis; bronchitis; chest infection; smoking; lung disease; lung; lungs

Outcome Measures

Primary Outcomes (1)

• Clinical failure at 8 weeks post therapy

  At day 63

Secondary Outcomes (13)

• Clinical failure rates

  Through to day 35

• Bacteriological eradication rates

  Through to day 63

• Clinical failure rates for subjects with positive sputum culture at enrollment

  Through to day 63

• Weekly mean symptom scores measured by the AECB SS

  Through to day 63

• Rates and speed of symptom relief measured by the AECB SS

  Through to day 63

Study Arms (2)

Arm 2

ACTIVE COMPARATOR

Drug: Amoxicillin clavulanic acid

Arm 1

EXPERIMENTAL

Drug: Avelox (Moxifloxacin, BAY12-8039)

Interventions

Avelox (Moxifloxacin, BAY12-8039) DRUG

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.

Arm 1

Amoxicillin clavulanic acid DRUG

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 2

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bayer: lead

Study Sites (220)

Unknown Facility

Les Escaldes, Andorra

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Quilmes, Buenos Aires, Argentina

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San Juan Bautista, Buenos Aires, Argentina

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Buenos Aires, Ciudad Auton. de Buenos Aires, 1426, Argentina

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Buenos Aires, Ciudad Auton. de Buenos Aires, C1424BSF, Argentina

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Buenos Aires, Ciudad Auton. de Buenos Aires, C1425AWC, Argentina

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Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

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San Miguel de Tucumán, Tucumán Province, 4000, Argentina

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San Miguel de Tucumán, Tucumán Province, Argentina

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Vicente López, 1638, Argentina

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Concord, New South Wales, 2139, Australia

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Brisbane, Queensland, 4101, Australia

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Adelaide, South Australia, 5041, Australia

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Woodville, South Australia, 5011, Australia

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Nedlands, Western Australia, 6009, Australia

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Aalst, 9300, Belgium

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Antwerp, 2018, Belgium

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Bruxelles - Brussel, 1020, Belgium

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Halen, 3545, Belgium

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Lommel, 3920, Belgium

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Moerkerke, 8340, Belgium

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Namur, 5000, Belgium

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Yvoir, 5530, Belgium

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Juiz de Fora, Minas Gerais, 36036-110, Brazil

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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

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São Paulo, São Paulo, 04032-060, Brazil

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São Paulo, São Paulo, 05403-900, Brazil

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Calgary, Alberta, T2N 4Z6, Canada

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Edmonton, Alberta, T6G 2B7, Canada

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Edmonton, Alberta, T6L 5X8, Canada

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Kelowna, British Columbia, V1Y 8E7, Canada

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Vancouver, British Columbia, V5Z 4E1, Canada

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Winnipeg, Manitoba, R3A 1R8, Canada

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Winnipeg, Manitoba, R3C 0N2, Canada

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Saint John, New Brunswick, E2K 2T8, Canada

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Saint John, New Brunswick, E2M 3W5, Canada

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Antigonish, Nova Scotia, B2G 2C2, Canada

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Sydney Mines, Nova Scotia, B1V 2Y5, Canada

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Burlington, Ontario, L7R 3X4, Canada

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Hamilton, Ontario, L8N 4A6, Canada

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London, Ontario, N6A 4V2, Canada

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London, Ontario, N6A 5G6, Canada

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Toronto, Ontario, M6H 3M2, Canada

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Longueuil, Quebec, J4N 1E1, Canada

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Montreal, Quebec, H2L 4M1, Canada

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Sherbrooke, Quebec, JIH 4J6, Canada

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Santiago, Chile

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Valparaíso, Chile

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Viña del Mar, Chile

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Guangzhou, Guangdong, 510120, China

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Guangzhou, Guangdong, 510405, China

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Changsha, Hunan, 410013, China

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Shengyang, Liaoning, 110004, China

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Shenyang, Liaoning, 110001, China

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Chengdu, Sichuan, 610041, China

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Beijing, 100020, China

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Beijing, 100050, China

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Shanghai, 200003, China

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Shanghai, 200040, China

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Shanghai, 200233, China

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Tianjin, 300052, China

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Cali, Cauca Department, Colombia

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Bogotá, Colombia

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Bucaramanga, Colombia

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Cali, Colombia

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Medellín, Colombia

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Osijek, 310 00, Croatia

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Petrinja, 44 250, Croatia

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Rijeka, 510 00, Croatia

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Zagreb, 10000, Croatia

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Kyjov, 697 01, Czechia

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Lovosice, 410 02, Czechia

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Neratovice, 227 11, Czechia

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Pardubice - Trnova, 530 09, Czechia

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Praha - Malesice, 108 00, Czechia

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Praha - Troja, 182 00, Czechia

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Marseille, 13009, France

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Mont-de-Marsan, 40000, France

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Nice, 06000, France

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Perpignan, 66025, France

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Bad Dürrheim, Baden-Wurttemberg, 78073, Germany

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Augsburg, Bavaria, 86150, Germany

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Cottbus, Brandenburg, 03050, Germany

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Rüdersdorf, Brandenburg, 15562, Germany

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Zossen, Brandenburg, 15806, Germany

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Hamburg, Hamburg, 20354, Germany

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Hamburg, Hamburg, 22305, Germany

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Frankfurt am Main, Hesse, 60318, Germany

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Frankfurt am Main, Hesse, 60389, Germany

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Fulda, Hesse, 36039, Germany

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Neubrandenburg, Mecklenburg-Vorpommern, 17033, Germany

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Lüdenscheid, North Rhine-Westphalia, 58515, Germany

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Neuwied, Rhineland-Palatinate, 56564, Germany

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Böhlen, Saxony, 04564, Germany

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Delitzsch, Saxony, 04509, Germany

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Dresden, Saxony, 01307, Germany

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Leipzig, Saxony, 04207, Germany

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Leipzig, Saxony, 04275, Germany

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Leipzig, Saxony, 04357, Germany

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Meissen, Saxony, 01662, Germany

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Bad Segeberg, Schleswig-Holstein, 23795, Germany

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Lübeck, Schleswig-Holstein, 23552, Germany

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Berlin, State of Berlin, 10365, Germany

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Berlin, State of Berlin, 10717, Germany

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Berlin, State of Berlin, 10969, Germany

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Berlin, State of Berlin, 12043, Germany

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Berlin, State of Berlin, 12203, Germany

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Berlin, State of Berlin, 13597, Germany

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Berlin, State of Berlin, 14059, Germany

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Athens, Attica, 106 76, Greece

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Mezourlo, Larissa, 41110, Greece

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Rio, Patras, 265 04, Greece

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Athens, 11527, Greece

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Ioannina, 45500, Greece

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Hong Kong, Hong Kong

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Kowloon, Hong Kong

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Bandung, Indonesia

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Jakarta, 13230, Indonesia

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Surabaya, Indonesia

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Killarney, Kerry, Ireland

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Longford, Longford, Ireland

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Enniscorthy, Wexford, Ireland

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Gorey, Wexford, Ireland

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Bray, Wicklow, Ireland

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Pregiato Di Cava Dei Tirreni, Salerno, 84013, Italy

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Busto Arsizio, Varese, 21052, Italy

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Bussolengo, Verona, 37012, Italy

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Ascoli Piceno, 63100, Italy

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Catania, 95122, Italy

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Chieti, 66100, Italy

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Milan, 20123, Italy

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Milan, 20157, Italy

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Perugia, 06156, Italy

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Krāslava, 5601, Latvia

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Riga, 1009, Latvia

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Riga, 1011, Latvia

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Riga, 1050, Latvia

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Talsu, 3201, Latvia

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Valmiera, 4201, Latvia

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Ventspils, LV-3601, Latvia

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Kaunas, LT-50425, Lithuania

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Kaunas, Lithuania

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Klaipėda, LT-94231, Lithuania

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Šiauliai, 76231, Lithuania

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Vilnius, LT-06122, Lithuania

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Vilnius, LT-07156, Lithuania

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Chihuahua City, Chihuahua, 31350, Mexico

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Guadalajara, Jalisco, 44280, Mexico

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Monterrey, Nuevo León, 64718, Mexico

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Monterrey, Nuevo León, 66480, Mexico

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Huixquilucan, State of Mexico, CP 52763, Mexico

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Mérida, Yucatán, 97001, Mexico

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Zacatecas City, Zacatecas, 98608, Mexico

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Eindhoven, North Brabant, 5623 EJ, Netherlands

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Heerlen, 6419 PC, Netherlands

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Hoofddorp, 2134 TM, Netherlands

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Meppel, 7943 KA, Netherlands

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Utrecht, 3582 KE, Netherlands

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Karachi, Sindh, 74800, Pakistan

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Islamabad, Pakistan

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Karachi, 75500, Pakistan

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Lima, Lima Province, LIMA 18, Peru

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Callao, CALLAO 2, Peru

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Lima, 31, Peru

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Lima, 33, Peru

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Lima, LIMA 27, Peru

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Lima, Peru

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Manila, Philippines

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Quezon City, Philippines

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Coimbra, Coimbra District, 3000-075, Portugal

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Torres Vedras, Lisbon District, 2560-324, Portugal

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Matosinhos Municipality, Porto District, 4454-509, Portugal

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Vila Nova de Gaia, Porto District, 4434-502, Portugal

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Lisbon, 1169-024, Portugal

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Lisbon, 1649-035, Portugal

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Porto, 4200, Portugal

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S. Martinho Do Bispo, 3041-856, Portugal

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Santarém, 2005-177, Portugal

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Port Elizabeth, Eastern Cape, 6014, South Africa

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Bloemfontein, Freestate, 9324, South Africa

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Benoni, Gauteng, 1500, South Africa

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Centurion, Gauteng, 0140, South Africa

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Kempton Park, Gauteng, 1610, South Africa

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Pretoria, Gauteng, 0002, South Africa

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Pretoria, Gauteng, 0084, South Africa

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Pretoria, Gauteng, South Africa

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Durban, KwaZulu-Natal, 4037, South Africa

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Durban, KwaZulu-Natal, 4091, South Africa

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Thabazimbi, Limpopo, 0380, South Africa

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Witbank, Mpumalanga, 1035, South Africa

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Cape Town, Western Cape, 7505, South Africa

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Paarl, Western Cape, 7647, South Africa

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Somerset West, Western Cape, 7130, South Africa

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Badalona, Barcelona, 08916, Spain

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Barcelona, Barcelona, 08034, Spain

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Barcelona, Barcelona, 08036, Spain

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Sant Boi de Llobregat, Barcelona, 08830, Spain

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Guadalajara, Guadalajara, 19002, Spain

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Palma de Mallorca, Illes Baleares, 07010, Spain

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Madrid, Madrid, 28040, Spain

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Requena, Valencia, 46340, Spain

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Laufen, Basel-Landschaft, 4242, Switzerland

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Oberwil, Basel-Landschaft, 4104, Switzerland

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Aarau, Canton of Aargau, 5000, Switzerland

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Binningen, Canton of Basel-City, 4102, Switzerland

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Bern, Canton of Bern, 3004, Switzerland

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Zurich, Canton of Zurich, 8048, Switzerland

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Zurich, Canton of Zurich, 8091, Switzerland

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Basel, 4031, Switzerland

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Thun, 3600, Switzerland

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Wettingen, 5430, Switzerland

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Chiang Mai, Thailand, 50200, Thailand

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Bangkok, 10330, Thailand

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Nonthaburi, 11000, Thailand

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Glasgow, Stratchclyde, G3 8YJ, United Kingdom

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Glasgow, Stratchclyde, G45 9AW, United Kingdom

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Glasgow, Stratchclyde, G46 8NY, United Kingdom

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Glasgow, Stratchclyde, G69 7AD, United Kingdom

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Glasgow, Stratchclyde, United Kingdom

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Coventry, Warwickshire, CV7 8LA, United Kingdom

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Related Publications (2)

• 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.

  PMID: 21760724 RESULT

• 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.

  PMID: 26082623 DERIVED

Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

MeSH Terms

Conditions

Bronchitis, Chronic; Pulmonary Disease, Chronic Obstructive; Bronchitis; Smoking; Lung Diseases

Interventions

Moxifloxacin; Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2008
• First Posted: April 11, 2008
• Study Start: March 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 1, 2014

Record last verified: 2014-11

Locations

DE (29); LI (6); GR (5); PE (6); AN (1); ZA (15); PT (9); LA (7); AU (5); CZ (6); ES (8); PA (3); CH (10); HK (2); NL (5); IE (5); BR (4); AR (9); ID (3); TH (3); PH (2); CN (12); CR (4); CL (3); CO (5); BE (8); CA (19); FR (4); GB (6); ME (7); IT (9)