check_circleStudy Completed
Chronic Bronchitis
Bayer Identifier:
11980
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Moxifloxacin versus amoxicillin clavulanic acid in treatment of acute exacerbation of chronic bronchitis
Trial 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.
Key Participants Requirements
Sex
BothAge
60 YearsTrial summary
Enrollment Goal
1372Trial Dates
March 2008 - December 2010Phase
Phase 4Could I Receive a placebo
NoProducts
Avelox (Moxifloxacin hydrochloride, BAY12-8039)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Praxis Hr. Dr. A. Colberg | Bad Segeberg, 23795, Germany |
Terminated | Praxis Hr. Dr. R. Gebhardt | Berlin, 12043, Germany |
Completed | Ambulantes Zentrum für Lungenkrankheiten | Cottbus, 03050, Germany |
Completed | Praxis Hr. Dr. Th. Schultz | Berlin, 12203, Germany |
Terminated | Praxis Hr. Dr. G. Hoheisel | Leipzig, 04275, Germany |
Completed | Praxis Drs. Laumen/Wiederhold | Fulda, 36039, Germany |
Completed | Praxis Hr. Dr. M. Huntemann | Lüdenscheid, 58515, Germany |
Terminated | Gemeinschaftspraxis Innere Medizin | Augsburg, 86150, Germany |
Completed | Praxis Fr. Dr. K. Todoroff | Bad Dürrheim, 78073, Germany |
Completed | Praxis Hr. Dr. J. C. Becker | Lübeck, 23552, Germany |
Terminated | Gemeinschaftspraxis & Zentrum | Frankfurt, 60318, Germany |
Terminated | Praxis Fr. Dr. K. Böhm | Neubrandenburg, 17033, Germany |
Completed | Praxis Hr. Dr. C. Geßner | Leipzig, 04357, Germany |
Completed | Praxis Drs.Deckelmann/Eckhardt | Leipzig, 04207, Germany |
Terminated | Praxis Hr. Dr. J. Hampf | Meißen, 01662, Germany |
Completed | Praxis fü Lungen- und Bronchialheilkunde, | Berlin, 10717, Germany |
Terminated | IFG Institut für Gesundheitsförderung GmbH | Rüdersdorf, 15562, Germany |
Completed | Praxis Hr. Dr. M. Raffenberg | Zossen, 15806, Germany |
Completed | Praxis Drs. Westerhausen/Pettenkofer/Klüppelberg | Berlin, 10969, Germany |
Completed | Gemeinschaftspraxis Drs. Hartjen, Sostmann, Timmermann | Hamburg, 20354, Germany |
Completed | Medizinisches AllergoPneumologisches Versorgungszentrum | Dresden, 01307, Germany |
Completed | Praxis Hr. Dr. A. de Roux | Berlin, 14059, Germany |
Terminated | Praxis Hr. Dr. J. Groth | Neuwied, 56564, Germany |
Completed | Medizinsches Versorgungszentrum Delitzsch | Delitzsch, 04509, Germany |
Terminated | Praxis Hr. Dr. J. Eller | Berlin, 13597, Germany |
Terminated | Gemeinschaftspraxis Dr. Grützmacher / Dr. tenHoff | Hamburg, 22305, Germany |
Terminated | Praxis Hr. Dr. H.-H. Ponitz / Hr. Dr. G. Hoppe | Berlin, 10365, Germany |
Completed | Praxis Hr. Dr. A. Schwittay | Böhlen, 04564, Germany |
Completed | Baillieston Health Centre | Glasgow, G69 7AD, United Kingdom |
Terminated | Centre d'allergologie et de pneumologie respiratoire | PERPIGNAN, 66025, France |
Terminated | Ospedale San Giuseppe FbF Polo Universitario | Milano, 20123, Italy |
Terminated | A.O. Sacco Polo Universitario | Milano, 20157, Italy |
Terminated | A.O. di Perugia | Perugia, 06156, Italy |
Completed | ASL Salerno - Campania | Pregiato di Cava dei Tirreni, 84013, Italy |
Terminated | AULSS 22 Bussolengo - Veneto | Bussolengo, 37012, Italy |
Terminated | Hospital Clínico Universitario San Carlos | Madrid, 28040, Spain |
Completed | Hospital General de Requena | Requena, 46340, Spain |
Completed | Scimed Research, Inc. | Kelowna, V1Y 8E7, Canada |
Completed | Antigonish Clinical Trials | Antigonish, B2G 2C2, Canada |
Completed | CHUM - Hopital Notre-Dame | Montreal, H2L 4M1, Canada |
Terminated | Q & T Research, Inc. | Sherbrooke, JIH 4J6, Canada |
Completed | University of Calgary | Calgary, T2N 4Z6, Canada |
Terminated | St.Joseph's Health Care-London | London, N6A 4V2, Canada |
Terminated | Anderston Medical Centre | Glasgow, G3 8YJ, United Kingdom |
Terminated | Park Leys Medical Practice | Coventry, CV7 8LA, United Kingdom |
Terminated | The Surgery | Glasgow, United Kingdom |
Completed | Thornliebank Health Centre | Glasgow, G46 8NY, United Kingdom |
Completed | Castlemilk Health Centre | Glasgow, G45 9AW, United Kingdom |
Terminated | Cabinet médical - Cronstadt - Nice | NICE, 06000, France |
Terminated | Cabinet Médical - Morgiou - Marseille | MARSEILLE, 13009, France |
Terminated | Cabinet Médical - Martinon - Mont de Marsan | MONT-DE-MARSAN, 40000, France |
Completed | AUSL 2 Lanciano-Vasto-Chieti - Abruzzo | Chieti, 66100, Italy |
Completed | ASUR Marche ZT13 Ascoli Piceno | Ascoli Piceno, 63100, Italy |
Completed | A.O. Ospedale Circolo Busto Arsizio | Busto Arsizio, 21052, Italy |
Terminated | ARNAS Garibaldi | Catania, 95122, Italy |
Completed | Hospital Universitari Germans Trias i Pujol | Badalona, 08916, Spain |
Completed | Hospital Universitari Son Espases | Palma de Mallorca, 07010, Spain |
Terminated | Hospital General Universitario de Guadalajara | Guadalajara, 19002, Spain |
Terminated | St. Joseph's Healthcare - Hamilton | Hamilton, L8N 4A6, Canada |
Completed | Medical Clinic | Sydney Mines, B1V 2Y5, Canada |
Completed | Grey Nun's Community Hospital | Edmonton, T6L 5X8, Canada |
Terminated | Health Science Centre | Winnipeg, R3A 1R8, Canada |
Terminated | Primary Care Lung Clinic | Toronto, M6H 3M2, Canada |
Completed | Office of Dr.Robert Luton, MD | London, N6A 5G6, Canada |
Terminated | Clinique Invascor Inc. | Longueuil, J4N 1E1, Canada |
Completed | JBN Medical Diagnostic Services, Inc. | Burlington, L7R 3X4, Canada |
Terminated | CU de Mont-Godinne | YVOIR, 5530, Belgium |
Completed | Dr. Vereecken | HALEN, 3545, Belgium |
Completed | Catharina | EINDHOVEN, 5623 EJ, Netherlands |
Terminated | Diaconessenhuis Meppel | MEPPEL, 7943 KA, Netherlands |
Terminated | Diakonessenhuis | UTRECHT, 3582 KE, Netherlands |
Completed | Hospital Central Universitario | Chihuahua, 31350, Mexico |
Completed | Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde" | Guadalajara, 44280, Mexico |
Terminated | Centro Médico de las Américas | Mérida, 97001, Mexico |
Completed | Hospital General del Parc Sanitari de Sant Joan de Déu | Sant Boi de Llobregat, 08830, Spain |
Completed | CAP Sarrià | Barcelona, 08034, Spain |
Completed | Consorci d’Atenció Primària de Salut de l’Eixample | Barcelona, 08036, Spain |
Completed | Office of Dr. Tharwat Fera, MD | Vancouver, V5Z 4E1, Canada |
Completed | Winnipeg Clinic | Winnipeg, R3C 0N2, Canada |
Completed | University of Alberta | Edmonton, T6G 2B7, Canada |
Terminated | Office of Dr. Graham W. Bishop, MD | Saint John, E2M 3W5, Canada |
Terminated | Office of Dr. Brian Craig, MD | Saint John, E2K 2T8, Canada |
Completed | Algemeen Stedelijk Ziekenhuis Campus Aalst | AALST, 9300, Belgium |
Terminated | Sint-Vincentiusziekenhuis Campus Sint-Vincentiusziekenhuis | ANTWERPEN, 2018, Belgium |
Completed | Dr. MARTINOT Jean-Benoît | NAMUR, 5000, Belgium |
Terminated | CHU Brugmann/UVC Brugmann | BRUXELLES - BRUSSEL, 1020, Belgium |
Terminated | Dr. Hutsebaut | MOERKERKE, 8340, Belgium |
Terminated | Dr. Huysmans | LOMMEL, 3920, Belgium |
Completed | Atrium Medisch Centrum Parkstad | HEERLEN, 6419 PC, Netherlands |
Terminated | Spaarne Ziekenhuis | HOOFDDORP, 2134 TM, Netherlands |
Terminated | Hospital Ángeles Lomas | Huixquilucan, CP 52763, Mexico |
Completed | Hospital San Agustín Zacatecas | Zacatecas, 98608, Mexico |
Completed | Worthwhile Clinical Trials | Benoni, 1500, South Africa |
Completed | Paarl Research Centre | Paarl, 7647, South Africa |
Completed | Clinresco Kempton Park | Kempton Park, 1610, South Africa |
Completed | I. Engelbrecht Reseach (Pty) Ltd | Centurion, 0140, South Africa |
Completed | University of Stellenbosch | Cape Town, 7505, South Africa |
Completed | Vergelegen Medi-Clinic | Somerset West, 7130, South Africa |
Completed | Emmed Research | Pretoria, 0084, South Africa |
Completed | Intercare Medical & Dental Centre Glenfair | Pretoria, South Africa |
Terminated | sunnyside Mediclinic | Pretoria, 0002, South Africa |
Completed | Newkwa Medical Centre | Durban, 4037, South Africa |
Completed | Clinic of pulmonary diseases | Neratovice, 227 11, Czech Republic |
Terminated | Hospital Kyjov | Kyjov, 697 01, Czech Republic |
Completed | SPIiN | Praha - Troja, 182 00, Czech Republic |
Terminated | Hospital Metropolitano "Dr. Bernardo Sepúlveda" | Monterrey, 66480, Mexico |
Completed | Hospital General O'Horán SS | Mérida, 97001, Mexico |
Completed | Unidad de Investigación Clínica en Medicina | Monterrey, 64718, Mexico |
Completed | Josha Research | Bloemfontein, 9324, South Africa |
Completed | Randles Road Medical Centre | Durban, 4091, South Africa |
Completed | Park Medical Centre | Witbank, 1035, South Africa |
Completed | Tambotie Medical Centre | Thabazimbi, 0380, South Africa |
Completed | Mercantile Hospital Centre | Port Elizabeth, 6014, South Africa |
Completed | Clinic of pulmonary diseases | Praha - Malesice, 108 00, Czech Republic |
Completed | Clinic of pulmonary diseases and internal medicine | Lovosice, 410 02, Czech Republic |
Completed | Sir Charles Gairdner Hospital | Nedlands, 6009, Australia |
Completed | Repatriation General Hospital | Adelaide, 5041, Australia |
Terminated | Concord Repatriation General Hospital | Concord, 2139, Australia |
Terminated | Centro Hospitalar de Lisboa Ocidental-Hospital Santa Marta | Lisboa, 1169-024, Portugal |
Terminated | Centro Hospitalar Vila Nova de Gaia | Vila Nova de Gaia, 4434-502, Portugal |
Completed | Clinic of pulmonary diseases | Pardubice - Trnova, 530 09, Czech Republic |
Completed | Queen Elizabeth Hospital | Woodville, 5011, Australia |
Completed | Brisbane Mater Misericordiae Hospital | Brisbane, 4101, Australia |
Terminated | Centro Hospitalar Torres Vedras.H.Dr José Maria Antunes Jr | Torres Vedras, 2560-324, Portugal |
Terminated | Hospital de Santarém | Santarém, 2005-177, Portugal |
Terminated | Hospital Pedro Hispano | Matosinhos, 4454-509, Portugal |
Completed | Instituto Médico de Asistencia e Investigación | Buenos Aires, C1425AWC, Argentina |
Completed | Hospital Militar Central "CIR. MY. C. Argerich" | Buenos Aires, 1426, Argentina |
Completed | Centro Respiratorio Quilmes | Quilmes, Argentina |
Completed | Investigaciones en Patologías Respiratorias | San Miguel de Tucumán, Argentina |
Completed | Inst. de Dermatología y Neumonología "Dr. Carlos Luna" | Buenos Aires, Argentina |
Completed | Centro Médico Dra. De Salvo - Clinical Research Center | Buenos Aires, 1426, Argentina |
Completed | Hospital Carlos van Buren | Valparaíso, Chile |
Completed | Hospital Nacional del Tórax | Santiago, Chile |
Completed | Clínica Ciudad del Mar | Viña del Mar, Chile |
Completed | Centro Hospitalar Coimbra | S. Martinho do Bispo, 3041-856, Portugal |
Terminated | Centro Hospitalar de Lisboa Norte - Hospital Santa Maria | Lisboa, 1649-035, Portugal |
Terminated | Hospitais da Universidade de Coimbra | Coimbra, 3000-075, Portugal |
Terminated | Hospital de São João | Porto, 4200, Portugal |
Completed | Hospital Zonal de Agudos Dr. Antonio Cetrángolo | Vicente López, 1638, Argentina |
Terminated | Fund. Asistencia e Inv. Clínica en Enferm. Prevalentes | Buenos Aires, Argentina |
Completed | Hospital Centro de Salud Zenon Santillan | San Miguel de Tucumán, 4000, Argentina |
Completed | Centro de Investigaciones Médicas | Florencio Varela, Argentina |
Completed | Clínica del Sol | Buenos Aires, Argentina |
Completed | Centro de Enfermedades Respiratorias | Buenos Aires, C1424BSF, Argentina |
Completed | Hospital Gustavo Fricke | Viña del Mar, Chile |
Completed | Hospital Militar Central | Santafe de Bogotá, Colombia |
Completed | Centro Médico Imbanaco | Cali, Colombia |
Terminated | Instituto Neumológico de Oriente | Bucaramanga, Colombia |
Completed | Clínica Soma | Medellín, Colombia |
Completed | Clinica Avansalud | Santiago, Chile |
Completed | NeumoInvestigaciones | Bogotá, Colombia |
Terminated | Fundación Neumológica Colombiana | Bogotá, Colombia |
Completed | Hospital San Vicente de Paul | Medellín, Colombia |
Terminated | Fundación Clínica Valle del Lili | Cali, Colombia |
Completed | Clínica Medellín | Medellín, Colombia |
Completed | University General Hospital of Patras | Rio, 265 04, Greece |
Completed | University General Hospital of Larissa | Mezourlo, 41110, Greece |
Completed | Evangelismos General Hospital of Athens | Athens, 106 76, Greece |
Completed | Pontificia Universidade Católica do RS - Centro Clínico | Porto Alegre, 90610-000, Brazil |
Completed | Universidade Federal de Juiz de Fora- Hospital Universitario | Juiz de Fora, 36036-110, Brazil |
Completed | Hospital das Clínicas da Faculdade de Medicina da USP | São Paulo, 05403-900, Brazil |
Completed | first affiliated hospital of guangzhou medical college | Guangzhou, 510120, China |
Completed | West China Hospital, Sichuan University | Chengdu, 610041, China |
Completed | Centro de Investigación Clínica FOQUS | Bogotá, Colombia |
Completed | Sotiria General State Hospital of Chest Diseases | Athens, 11527, Greece |
Completed | Sotiria General State Hospital of Chest Diseases | Athens, 11527, Greece |
Completed | General University Hospital of Ioannina | Ioannina, 45500, Greece |
Completed | UNIFESP/EPM | São Paulo, 04032-060, Brazil |
Completed | Shanghai Changzheng Hospital | Shanghai, 200003, China |
Completed | Respiratory Diseases Institute, Beijing Chaoyang Hospital | Beijing, 100020, China |
Completed | Shengjing Hosp. of China Medical Univ. | Shengyang, 110004, China |
Completed | 1st Affiliated Hosp., Guangzhou Univ. TCM | Guangzhou, 510405, China |
Completed | Dr Soetomo Hospital | Surabaya, Indonesia |
Completed | Vilnius region outpatient department | Vilnius, LT-06122, Lithuania |
Completed | Saules family medicine center | Kaunas, LT-50425, Lithuania |
Completed | Silainiu family health center | Kaunas, Lithuania |
Terminated | Praxis Dr. U. Honegger | Zürich, 8048, Switzerland |
Terminated | Praxis Hr. Dr. T. Toth | Thun, 3600, Switzerland |
Completed | The 6th People's Hospital of Shanghai Jiao Tong University | Shanghai, 200233, China |
Completed | Shanghai Huadong Hospital | Shanghai, 200040, China |
Completed | General Hospital, Tianjin Medical University | Tianjin, 300052, China |
Completed | Beijing Friendship Hosp. | Beijing, 100050, China |
Completed | The First hospital of China Medical University | Shenyang, 110001, China |
Completed | The Third Xiangya Hospital of Central South University | Changsha, 410013, China |
Completed | Persahabatan Hospital | Jakarta, 13230, Indonesia |
Completed | Immanuel Hospital | Bandung, Indonesia |
Terminated | Seskines outpatient clinic | Vilnius, LT-07156, Lithuania |
Completed | UAB "Mano seimos gydytojas" | Klaipeda, LT-94231, Lithuania |
Completed | Siauliai County Hospital | Siauliai, 76231, Lithuania |
Terminated | Praxis Hr. Dr. R. Siebenschein | Wettingen, 5430, Switzerland |
Completed | Universitätsspital Basel | Basel, 4031, Switzerland |
Terminated | Praxis Dr. med. P. Ruff | Oberwil, 4104, Switzerland |
Terminated | Praxis Dr. med. Martin Anton Tschan | Laufen, 4242, Switzerland |
Terminated | Spital Netz Bern Spital Tiefenau | Bern, 3004, Switzerland |
Terminated | Lungenpraxis Aarau | Aarau, 5000, Switzerland |
Terminated | Praxis Dr. med. Alexander Haegeli | Binningen, 4102, Switzerland |
Terminated | Universitätsspital Zürich | Zürich, 8091, Switzerland |
Completed | Clínica San Pablo | Lima, 33, Peru |
Terminated | Hospital Alberto Sabogal Sologuren | Callao, CALLAO 2, Peru |
Completed | Hospital Central de la Fuerza Aerea del Perú | Lima, LIMA 18, Peru |
Completed | Clínica Internacional | Lima, Peru |
Completed | Hospital Nacional Cayetano Heredia | Lima, 31, Peru |
Completed | Tuen Mun Hospital | HongKong, Hong Kong |
Completed | Manila Doctors Hospital | Manila, Philippines |
Completed | Lung Center of the Philippines | Quezon City, Philippines |
Terminated | Latvian Postdiploma Education Institute Ambulatory part | Riga, 1011, Latvia |
Terminated | Dr E Tirans Private Practice | Riga, 1009, Latvia |
Terminated | Dr Harasimjukas private practice | Valmiera, 4201, Latvia |
Completed | Ltd "BINI" (SIA "BINI") | Ventspils, LV-3601, Latvia |
Completed | Klinika za plucne bolesti Jordanovac | Zagreb, 10000, Croatia |
Completed | Clínica El Golf | Lima, LIMA 27, Peru |
Completed | Princess Margaret Hospital | Kowloon, Hong Kong |
Completed | Chest Disease Institute | Nonthaburi, 11000, Thailand |
Completed | Maharaj Nakorn Chiang Mai Hospital | Chiang Mai, 50200, Thailand |
Completed | King Chulalongkorn Memorial Hospital | Bangkok, 10330, Thailand |
Completed | Hospital Ntra. Sra. de Meritxell | Escaldes - Engordany, Andorra |
Completed | Gimenes Arstu prakse | Riga, 1050, Latvia |
Completed | SIA Talsi veselibas centrer | Talsu, 3201, Latvia |
Completed | Kraslavas hospital | Kraslava, 5601, Latvia |
Completed | KBC Rijeka | Rijeka, 510 00, Croatia |
Completed | OB dr. Ivo Pedisic | Petrinja, 44 250, Croatia |
Terminated | Gorey Medical Centre | Gorey, Ireland |
Completed | Farranfore Medical Centre | Killarney, Ireland |
Terminated | The Palms | Gorey, Ireland |
Terminated | Longford Centre | Longford, Ireland |
Terminated | Klinika za plucne bolesti Jordanovac | Zagreb, 10000, Croatia |
Terminated | KB Osijek | Osijek, 310 00, Croatia |
Completed | Klinicka bolnica Dubrava | Zagreb, 10000, Croatia |
Terminated | Townhall Clinic | Bray, Ireland |
Completed | Jinnah Postgraduate Medical Centre | Karachi, 75500, Pakistan |
Terminated | Liaquat National Hospital | Karachi, 74800, Pakistan |
Terminated | Shifa International Hospitals Limited | Islamabad, Pakistan |
Terminated | Praxis Hr. Dr. C. Keller | Frankfurt, 60389, Germany |
Completed | Slaney Medical Centre | Enniscorthy, Ireland |
Primary Outcome
- Clinical failure at 8 weeks post therapydate_rangeTime Frame:At day 63enhanced_encryptionnoSafety Issue:
Secondary Outcome
- Clinical failure ratesdate_rangeTime Frame:Through to day 35enhanced_encryptionnoSafety Issue:
- Bacteriological eradication ratesdate_rangeTime Frame:Through to day 63enhanced_encryptionnoSafety Issue:
- Clinical failure rates for subjects with positive sputum culture at enrollmentdate_rangeTime Frame:Through to day 63enhanced_encryptionnoSafety Issue:
- Weekly mean symptom scores measured by the AECB SSdate_rangeTime Frame:Through to day 63enhanced_encryptionnoSafety Issue:
- Rates and speed of symptom relief measured by the AECB SSdate_rangeTime Frame:Through to day 63enhanced_encryptionnoSafety Issue:
- Clinical failure rates for subjects with co-administration of systemic corticosteroids (stratum 1)date_rangeTime Frame:Through to day 63enhanced_encryptionnoSafety Issue:
- Clinical failure rates for subjects without co-administration of systemic corticosteroids (stratum 2)date_rangeTime Frame:Through to day 63enhanced_encryptionnoSafety Issue:
- Need for any change in dosage or additional respiratory medication such as bronchodilators and inhaled steroids, excluding short acting bronchodilatorsdate_rangeTime Frame:Through to day 63enhanced_encryptionnoSafety Issue:
- Improvement in symptoms burden measured by the AECB SSdate_rangeTime Frame:Through to day 63enhanced_encryptionnoSafety Issue:
- Improvement in health related QoL measured by the SGRQdate_rangeTime Frame:Through to day 63enhanced_encryptionnoSafety Issue:
- spirometry tests will be compared between treatment groupsdate_rangeTime Frame:Through to day 63enhanced_encryptionnoSafety Issue:
- 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 impairmentdate_rangeTime Frame:Through to day 63enhanced_encryptionnoSafety Issue:
- Safety and tolerability of moxifloxacin versus amoxicillin clavulanic acid, with particular attention to rates of diarrheadate_rangeTime Frame:Through to day 63enhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2Additional Information
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