check_circleStudy Completed

Chronic Bronchitis

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

Both

Age

60 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
1372
Trial Dates
March 2008 - December 2010
Phase
Phase 4
Could I Receive a placebo
No
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Praxis Hr. Dr. A. ColbergBad Segeberg, 23795, Germany
Terminated
Praxis Hr. Dr. R. GebhardtBerlin, 12043, Germany
Completed
Ambulantes Zentrum für LungenkrankheitenCottbus, 03050, Germany
Completed
Praxis Hr. Dr. Th. SchultzBerlin, 12203, Germany
Terminated
Praxis Hr. Dr. G. HoheiselLeipzig, 04275, Germany
Completed
Praxis Drs. Laumen/WiederholdFulda, 36039, Germany
Completed
Praxis Hr. Dr. M. HuntemannLüdenscheid, 58515, Germany
Terminated
Gemeinschaftspraxis Innere MedizinAugsburg, 86150, Germany
Completed
Praxis Fr. Dr. K. TodoroffBad Dürrheim, 78073, Germany
Completed
Praxis Hr. Dr. J. C. BeckerLübeck, 23552, Germany
Terminated
Gemeinschaftspraxis & ZentrumFrankfurt, 60318, Germany
Terminated
Praxis Fr. Dr. K. BöhmNeubrandenburg, 17033, Germany
Completed
Praxis Hr. Dr. C. GeßnerLeipzig, 04357, Germany
Completed
Praxis Drs.Deckelmann/EckhardtLeipzig, 04207, Germany
Terminated
Praxis Hr. Dr. J. HampfMeißen, 01662, Germany
Completed
Praxis fü Lungen- und Bronchialheilkunde,Berlin, 10717, Germany
Terminated
IFG Institut für Gesundheitsförderung GmbHRüdersdorf, 15562, Germany
Completed
Praxis Hr. Dr. M. RaffenbergZossen, 15806, Germany
Completed
Praxis Drs. Westerhausen/Pettenkofer/KlüppelbergBerlin, 10969, Germany
Completed
Gemeinschaftspraxis Drs. Hartjen, Sostmann, TimmermannHamburg, 20354, Germany
Completed
Medizinisches AllergoPneumologisches VersorgungszentrumDresden, 01307, Germany
Completed
Praxis Hr. Dr. A. de RouxBerlin, 14059, Germany
Terminated
Praxis Hr. Dr. J. GrothNeuwied, 56564, Germany
Completed
Medizinsches Versorgungszentrum DelitzschDelitzsch, 04509, Germany
Terminated
Praxis Hr. Dr. J. EllerBerlin, 13597, Germany
Terminated
Gemeinschaftspraxis Dr. Grützmacher / Dr. tenHoffHamburg, 22305, Germany
Terminated
Praxis Hr. Dr. H.-H. Ponitz / Hr. Dr. G. HoppeBerlin, 10365, Germany
Completed
Praxis Hr. Dr. A. SchwittayBöhlen, 04564, Germany
Completed
Baillieston Health CentreGlasgow, G69 7AD, United Kingdom
Terminated
Centre d'allergologie et de pneumologie respiratoirePERPIGNAN, 66025, France
Terminated
Ospedale San Giuseppe FbF Polo UniversitarioMilano, 20123, Italy
Terminated
A.O. Sacco Polo UniversitarioMilano, 20157, Italy
Terminated
A.O. di PerugiaPerugia, 06156, Italy
Completed
ASL Salerno - CampaniaPregiato di Cava dei Tirreni, 84013, Italy
Terminated
AULSS 22 Bussolengo - VenetoBussolengo, 37012, Italy
Terminated
Hospital Clínico Universitario San CarlosMadrid, 28040, Spain
Completed
Hospital General de RequenaRequena, 46340, Spain
Completed
Scimed Research, Inc.Kelowna, V1Y 8E7, Canada
Completed
Antigonish Clinical TrialsAntigonish, B2G 2C2, Canada
Completed
CHUM - Hopital Notre-DameMontreal, H2L 4M1, Canada
Terminated
Q & T Research, Inc.Sherbrooke, JIH 4J6, Canada
Completed
University of CalgaryCalgary, T2N 4Z6, Canada
Terminated
St.Joseph's Health Care-LondonLondon, N6A 4V2, Canada
Terminated
Anderston Medical CentreGlasgow, G3 8YJ, United Kingdom
Terminated
Park Leys Medical PracticeCoventry, CV7 8LA, United Kingdom
Terminated
The SurgeryGlasgow, United Kingdom
Completed
Thornliebank Health CentreGlasgow, G46 8NY, United Kingdom
Completed
Castlemilk Health CentreGlasgow, G45 9AW, United Kingdom
Terminated
Cabinet médical - Cronstadt - NiceNICE, 06000, France
Terminated
Cabinet Médical - Morgiou - MarseilleMARSEILLE, 13009, France
Terminated
Cabinet Médical - Martinon - Mont de MarsanMONT-DE-MARSAN, 40000, France
Completed
AUSL 2 Lanciano-Vasto-Chieti - AbruzzoChieti, 66100, Italy
Completed
ASUR Marche ZT13 Ascoli PicenoAscoli Piceno, 63100, Italy
Completed
A.O. Ospedale Circolo Busto ArsizioBusto Arsizio, 21052, Italy
Terminated
ARNAS GaribaldiCatania, 95122, Italy
Completed
Hospital Universitari Germans Trias i PujolBadalona, 08916, Spain
Completed
Hospital Universitari Son EspasesPalma de Mallorca, 07010, Spain
Terminated
Hospital General Universitario de GuadalajaraGuadalajara, 19002, Spain
Terminated
St. Joseph's Healthcare - HamiltonHamilton, L8N 4A6, Canada
Completed
Medical ClinicSydney Mines, B1V 2Y5, Canada
Completed
Grey Nun's Community HospitalEdmonton, T6L 5X8, Canada
Terminated
Health Science CentreWinnipeg, R3A 1R8, Canada
Terminated
Primary Care Lung ClinicToronto, M6H 3M2, Canada
Completed
Office of Dr.Robert Luton, MDLondon, 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-GodinneYVOIR, 5530, Belgium
Completed
Dr. VereeckenHALEN, 3545, Belgium
Completed
CatharinaEINDHOVEN, 5623 EJ, Netherlands
Terminated
Diaconessenhuis MeppelMEPPEL, 7943 KA, Netherlands
Terminated
DiakonessenhuisUTRECHT, 3582 KE, Netherlands
Completed
Hospital Central UniversitarioChihuahua, 31350, Mexico
Completed
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"Guadalajara, 44280, Mexico
Terminated
Centro Médico de las AméricasMérida, 97001, Mexico
Completed
Hospital General del Parc Sanitari de Sant Joan de DéuSant Boi de Llobregat, 08830, Spain
Completed
CAP SarriàBarcelona, 08034, Spain
Completed
Consorci d’Atenció Primària de Salut de l’EixampleBarcelona, 08036, Spain
Completed
Office of Dr. Tharwat Fera, MDVancouver, V5Z 4E1, Canada
Completed
Winnipeg ClinicWinnipeg, R3C 0N2, Canada
Completed
University of AlbertaEdmonton, T6G 2B7, Canada
Terminated
Office of Dr. Graham W. Bishop, MDSaint John, E2M 3W5, Canada
Terminated
Office of Dr. Brian Craig, MDSaint John, E2K 2T8, Canada
Completed
Algemeen Stedelijk Ziekenhuis Campus AalstAALST, 9300, Belgium
Terminated
Sint-Vincentiusziekenhuis Campus Sint-VincentiusziekenhuisANTWERPEN, 2018, Belgium
Completed
Dr. MARTINOT Jean-BenoîtNAMUR, 5000, Belgium
Terminated
CHU Brugmann/UVC BrugmannBRUXELLES - BRUSSEL, 1020, Belgium
Terminated
Dr. HutsebautMOERKERKE, 8340, Belgium
Terminated
Dr. HuysmansLOMMEL, 3920, Belgium
Completed
Atrium Medisch Centrum ParkstadHEERLEN, 6419 PC, Netherlands
Terminated
Spaarne ZiekenhuisHOOFDDORP, 2134 TM, Netherlands
Terminated
Hospital Ángeles LomasHuixquilucan, CP 52763, Mexico
Completed
Hospital San Agustín ZacatecasZacatecas, 98608, Mexico
Completed
Worthwhile Clinical TrialsBenoni, 1500, South Africa
Completed
Paarl Research CentrePaarl, 7647, South Africa
Completed
Clinresco Kempton ParkKempton Park, 1610, South Africa
Completed
I. Engelbrecht Reseach (Pty) LtdCenturion, 0140, South Africa
Completed
University of StellenboschCape Town, 7505, South Africa
Completed
Vergelegen Medi-ClinicSomerset West, 7130, South Africa
Completed
Emmed ResearchPretoria, 0084, South Africa
Completed
Intercare Medical & Dental Centre GlenfairPretoria, South Africa
Terminated
sunnyside MediclinicPretoria, 0002, South Africa
Completed
Newkwa Medical CentreDurban, 4037, South Africa
Completed
Clinic of pulmonary diseasesNeratovice, 227 11, Czech Republic
Terminated
Hospital KyjovKyjov, 697 01, Czech Republic
Completed
SPIiNPraha - Troja, 182 00, Czech Republic
Terminated
Hospital Metropolitano "Dr. Bernardo Sepúlveda"Monterrey, 66480, Mexico
Completed
Hospital General O'Horán SSMérida, 97001, Mexico
Completed
Unidad de Investigación Clínica en MedicinaMonterrey, 64718, Mexico
Completed
Josha ResearchBloemfontein, 9324, South Africa
Completed
Randles Road Medical CentreDurban, 4091, South Africa
Completed
Park Medical CentreWitbank, 1035, South Africa
Completed
Tambotie Medical CentreThabazimbi, 0380, South Africa
Completed
Mercantile Hospital CentrePort Elizabeth, 6014, South Africa
Completed
Clinic of pulmonary diseasesPraha - Malesice, 108 00, Czech Republic
Completed
Clinic of pulmonary diseases and internal medicineLovosice, 410 02, Czech Republic
Completed
Sir Charles Gairdner HospitalNedlands, 6009, Australia
Completed
Repatriation General HospitalAdelaide, 5041, Australia
Terminated
Concord Repatriation General HospitalConcord, 2139, Australia
Terminated
Centro Hospitalar de Lisboa Ocidental-Hospital Santa MartaLisboa, 1169-024, Portugal
Terminated
Centro Hospitalar Vila Nova de GaiaVila Nova de Gaia, 4434-502, Portugal
Completed
Clinic of pulmonary diseasesPardubice - Trnova, 530 09, Czech Republic
Completed
Queen Elizabeth HospitalWoodville, 5011, Australia
Completed
Brisbane Mater Misericordiae HospitalBrisbane, 4101, Australia
Terminated
Centro Hospitalar Torres Vedras.H.Dr José Maria Antunes JrTorres Vedras, 2560-324, Portugal
Terminated
Hospital de SantarémSantarém, 2005-177, Portugal
Terminated
Hospital Pedro HispanoMatosinhos, 4454-509, Portugal
Completed
Instituto Médico de Asistencia e InvestigaciónBuenos Aires, C1425AWC, Argentina
Completed
Hospital Militar Central "CIR. MY. C. Argerich"Buenos Aires, 1426, Argentina
Completed
Centro Respiratorio QuilmesQuilmes, Argentina
Completed
Investigaciones en Patologías RespiratoriasSan Miguel de Tucumán, Argentina
Completed
Inst. de Dermatología y Neumonología "Dr. Carlos Luna"Buenos Aires, Argentina
Completed
Centro Médico Dra. De Salvo - Clinical Research CenterBuenos Aires, 1426, Argentina
Completed
Hospital Carlos van BurenValparaíso, Chile
Completed
Hospital Nacional del TóraxSantiago, Chile
Completed
Clínica Ciudad del MarViña del Mar, Chile
Completed
Centro Hospitalar CoimbraS. Martinho do Bispo, 3041-856, Portugal
Terminated
Centro Hospitalar de Lisboa Norte - Hospital Santa MariaLisboa, 1649-035, Portugal
Terminated
Hospitais da Universidade de CoimbraCoimbra, 3000-075, Portugal
Terminated
Hospital de São JoãoPorto, 4200, Portugal
Completed
Hospital Zonal de Agudos Dr. Antonio CetrángoloVicente López, 1638, Argentina
Terminated
Fund. Asistencia e Inv. Clínica en Enferm. PrevalentesBuenos Aires, Argentina
Completed
Hospital Centro de Salud Zenon SantillanSan Miguel de Tucumán, 4000, Argentina
Completed
Centro de Investigaciones MédicasFlorencio Varela, Argentina
Completed
Clínica del SolBuenos Aires, Argentina
Completed
Centro de Enfermedades RespiratoriasBuenos Aires, C1424BSF, Argentina
Completed
Hospital Gustavo FrickeViña del Mar, Chile
Completed
Hospital Militar CentralSantafe de Bogotá, Colombia
Completed
Centro Médico ImbanacoCali, Colombia
Terminated
Instituto Neumológico de OrienteBucaramanga, Colombia
Completed
Clínica SomaMedellín, Colombia
Completed
Clinica AvansaludSantiago, Chile
Completed
NeumoInvestigacionesBogotá, Colombia
Terminated
Fundación Neumológica ColombianaBogotá, Colombia
Completed
Hospital San Vicente de PaulMedellín, Colombia
Terminated
Fundación Clínica Valle del LiliCali, Colombia
Completed
Clínica MedellínMedellín, Colombia
Completed
University General Hospital of PatrasRio, 265 04, Greece
Completed
University General Hospital of LarissaMezourlo, 41110, Greece
Completed
Evangelismos General Hospital of AthensAthens, 106 76, Greece
Completed
Pontificia Universidade Católica do RS - Centro ClínicoPorto Alegre, 90610-000, Brazil
Completed
Universidade Federal de Juiz de Fora- Hospital UniversitarioJuiz de Fora, 36036-110, Brazil
Completed
Hospital das Clínicas da Faculdade de Medicina da USPSão Paulo, 05403-900, Brazil
Completed
first affiliated hospital of guangzhou medical collegeGuangzhou, 510120, China
Completed
West China Hospital, Sichuan UniversityChengdu, 610041, China
Completed
Centro de Investigación Clínica FOQUSBogotá, Colombia
Completed
Sotiria General State Hospital of Chest DiseasesAthens, 11527, Greece
Completed
Sotiria General State Hospital of Chest DiseasesAthens, 11527, Greece
Completed
General University Hospital of IoanninaIoannina, 45500, Greece
Completed
UNIFESP/EPMSão Paulo, 04032-060, Brazil
Completed
Shanghai Changzheng HospitalShanghai, 200003, China
Completed
Respiratory Diseases Institute, Beijing Chaoyang HospitalBeijing, 100020, China
Completed
Shengjing Hosp. of China Medical Univ.Shengyang, 110004, China
Completed
1st Affiliated Hosp., Guangzhou Univ. TCMGuangzhou, 510405, China
Completed
Dr Soetomo HospitalSurabaya, Indonesia
Completed
Vilnius region outpatient departmentVilnius, LT-06122, Lithuania
Completed
Saules family medicine centerKaunas, LT-50425, Lithuania
Completed
Silainiu family health centerKaunas, Lithuania
Terminated
Praxis Dr. U. HoneggerZürich, 8048, Switzerland
Terminated
Praxis Hr. Dr. T. TothThun, 3600, Switzerland
Completed
The 6th People's Hospital of Shanghai Jiao Tong UniversityShanghai, 200233, China
Completed
Shanghai Huadong HospitalShanghai, 200040, China
Completed
General Hospital, Tianjin Medical UniversityTianjin, 300052, China
Completed
Beijing Friendship Hosp.Beijing, 100050, China
Completed
The First hospital of China Medical UniversityShenyang, 110001, China
Completed
The Third Xiangya Hospital of Central South UniversityChangsha, 410013, China
Completed
Persahabatan HospitalJakarta, 13230, Indonesia
Completed
Immanuel HospitalBandung, Indonesia
Terminated
Seskines outpatient clinicVilnius, LT-07156, Lithuania
Completed
UAB "Mano seimos gydytojas"Klaipeda, LT-94231, Lithuania
Completed
Siauliai County HospitalSiauliai, 76231, Lithuania
Terminated
Praxis Hr. Dr. R. SiebenscheinWettingen, 5430, Switzerland
Completed
Universitätsspital BaselBasel, 4031, Switzerland
Terminated
Praxis Dr. med. P. RuffOberwil, 4104, Switzerland
Terminated
Praxis Dr. med. Martin Anton TschanLaufen, 4242, Switzerland
Terminated
Spital Netz Bern Spital TiefenauBern, 3004, Switzerland
Terminated
Lungenpraxis AarauAarau, 5000, Switzerland
Terminated
Praxis Dr. med. Alexander HaegeliBinningen, 4102, Switzerland
Terminated
Universitätsspital ZürichZürich, 8091, Switzerland
Completed
Clínica San PabloLima, 33, Peru
Terminated
Hospital Alberto Sabogal SologurenCallao, CALLAO 2, Peru
Completed
Hospital Central de la Fuerza Aerea del PerúLima, LIMA 18, Peru
Completed
Clínica InternacionalLima, Peru
Completed
Hospital Nacional Cayetano HerediaLima, 31, Peru
Completed
Tuen Mun HospitalHongKong, Hong Kong
Completed
Manila Doctors HospitalManila, Philippines
Completed
Lung Center of the PhilippinesQuezon City, Philippines
Terminated
Latvian Postdiploma Education Institute Ambulatory partRiga, 1011, Latvia
Terminated
Dr E Tirans Private PracticeRiga, 1009, Latvia
Terminated
Dr Harasimjukas private practiceValmiera, 4201, Latvia
Completed
Ltd "BINI" (SIA "BINI")Ventspils, LV-3601, Latvia
Completed
Klinika za plucne bolesti JordanovacZagreb, 10000, Croatia
Completed
Clínica El GolfLima, LIMA 27, Peru
Completed
Princess Margaret HospitalKowloon, Hong Kong
Completed
Chest Disease InstituteNonthaburi, 11000, Thailand
Completed
Maharaj Nakorn Chiang Mai HospitalChiang Mai, 50200, Thailand
Completed
King Chulalongkorn Memorial HospitalBangkok, 10330, Thailand
Completed
Hospital Ntra. Sra. de MeritxellEscaldes - Engordany, Andorra
Completed
Gimenes Arstu prakseRiga, 1050, Latvia
Completed
SIA Talsi veselibas centrerTalsu, 3201, Latvia
Completed
Kraslavas hospitalKraslava, 5601, Latvia
Completed
KBC RijekaRijeka, 510 00, Croatia
Completed
OB dr. Ivo PedisicPetrinja, 44 250, Croatia
Terminated
Gorey Medical CentreGorey, Ireland
Completed
Farranfore Medical CentreKillarney, Ireland
Terminated
The PalmsGorey, Ireland
Terminated
Longford CentreLongford, Ireland
Terminated
Klinika za plucne bolesti JordanovacZagreb, 10000, Croatia
Terminated
KB OsijekOsijek, 310 00, Croatia
Completed
Klinicka bolnica DubravaZagreb, 10000, Croatia
Terminated
Townhall ClinicBray, Ireland
Completed
Jinnah Postgraduate Medical CentreKarachi, 75500, Pakistan
Terminated
Liaquat National HospitalKarachi, 74800, Pakistan
Terminated
Shifa International Hospitals LimitedIslamabad, Pakistan
Terminated
Praxis Hr. Dr. C. KellerFrankfurt, 60389, Germany
Completed
Slaney Medical CentreEnniscorthy, Ireland

Primary Outcome

  • Clinical failure at 8 weeks post therapy
    date_rangeTime Frame:
    At day 63
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Clinical failure rates
    date_rangeTime Frame:
    Through to day 35
    enhanced_encryption
    Safety Issue:
    no
  • Bacteriological eradication rates
    date_rangeTime Frame:
    Through to day 63
    enhanced_encryption
    Safety Issue:
    no
  • Clinical failure rates for subjects with positive sputum culture at enrollment
    date_rangeTime Frame:
    Through to day 63
    enhanced_encryption
    Safety Issue:
    no
  • Weekly mean symptom scores measured by the AECB SS
    date_rangeTime Frame:
    Through to day 63
    enhanced_encryption
    Safety Issue:
    no
  • Rates and speed of symptom relief measured by the AECB SS
    date_rangeTime Frame:
    Through to day 63
    enhanced_encryption
    Safety Issue:
    no
  • Clinical failure rates for subjects with co-administration of systemic corticosteroids (stratum 1)
    date_rangeTime Frame:
    Through to day 63
    enhanced_encryption
    Safety Issue:
    no
  • Clinical failure rates for subjects without co-administration of systemic corticosteroids (stratum 2)
    date_rangeTime Frame:
    Through to day 63
    enhanced_encryption
    Safety Issue:
    no
  • Need for any change in dosage or additional respiratory medication such as bronchodilators and inhaled steroids, excluding short acting bronchodilators
    date_rangeTime Frame:
    Through to day 63
    enhanced_encryption
    Safety Issue:
    no
  • Improvement in symptoms burden measured by the AECB SS
    date_rangeTime Frame:
    Through to day 63
    enhanced_encryption
    Safety Issue:
    no
  • Improvement in health related QoL measured by the SGRQ
    date_rangeTime Frame:
    Through to day 63
    enhanced_encryption
    Safety Issue:
    no
  • spirometry tests will be compared between treatment groups
    date_rangeTime Frame:
    Through to day 63
    enhanced_encryption
    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
    date_rangeTime Frame:
    Through to day 63
    enhanced_encryption
    Safety Issue:
    no
  • Safety and tolerability of moxifloxacin versus amoxicillin clavulanic acid, with particular attention to rates of diarrhea
    date_rangeTime Frame:
    Through to day 63
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2