Full Text View
Tabular View
No Study Results Posted
Related Studies
Moxifloxacin for the Treatment of Acute Exacerbation of Chronic Bronchitis
This study is currently recruiting participants.
Verified by Bayer, September 2009
First Received: April 4, 2008   Last Updated: September 30, 2009   History of Changes
Sponsor: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00656747
  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
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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:
  • The primary efficacy variable is clinical failure at 8 weeks post therapy. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary efficacy variables are:- clinical efficacy rates at the During Therapy, EOT, and 4 weeks Post therapy [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Bacteriological eradication rates at During Therapy, EOT, 4 weeks Post therapy, and 8 weeks Post therapy visits [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Clinical efficacy rates for subjects with positive sputum culture at enrollment at the During Therapy, EOT, 4 weeks Post therapy, and 8 weeks Post therapy visits [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Weekly mean symptom scores measured by the AECB SS [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Rates and speed of symptom relief measured by the AECB SS [ Time Frame: 18 months ] [ 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: 18 months ] [ Designated as safety issue: No ]
  • Improvement in symptoms burden measured by the AECB SS [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Improvement in health related QoL measured by the SGRQ [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Lung function test will be compared between treatment groups at each assessment visit [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • HCRU related to chronic bronchitis management including rescue medications, concomitant medications, therapeutic adjuncts, diagnostic procedures, [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Other medical care/medical staff requirement, hospitalizations (including ward and duration), and work productivity and activity impairment [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Safety and tolerability of moxifloxacin versus amoxicillin clavulanic acid, with particular attention to rates of diarrhea [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1786
Study Start Date: March 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 2: Active Comparator Drug: Amoxicillin
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.
Arm 1: Experimental 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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients
  • Male or female subjects, >/=60 years old
  • Subject who can be managed with oral antimicrobials
  • FEV1>/=50% predicted at enrollment in addition to a historical record of FEV1 of >/=60% within the past 12 months obtained during a stable infection-free period. A historical record of FEV1 is not required if the enrollment FEV1 is >/=50%.
  • 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
  • Subject must provide a purulent sputum sample by deep expectoration prior to randomization for Gram stain, culture and sensitivity testing. The sputum will be assessed macroscopically by the investigator and graded according to the provided color chart.
  • Current or past cigarette smoker with >/=20 pack year smoking history
  • Subjects must have an infection-free interval of at least 30 days prior to enrollment
  • Subjects must be willing and able to complete the questionnaires and subject booklet without assistance
  • Subjects with medical conditions and social status at the time of enrollment compatible with study protocol procedures
  • Willing and able to provide written informed consent

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
  • 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
  • Requiring hemodialysis
  • History of a tendon disease/disorder
  • Known history of liver dysfunction, including known elevated transaminases (ALT and/or AST >3 times the upper limit of normal)
  • Known severe renal impairment with glomerular filtration rate of <30mL/min
  • Known neutropenia (neutrophil count <1000/mm3) caused by immunosuppressive therapy or malignancy
  • Known to have AIDS (CD4 count of <200/mm3), or be HIV positive and receiving Highly Active Anti Retroviral Therapy (HAART) (HIV testing is not mandatory)
  • Known bronchial carcinoma, active pulmonary tuberculosis, known diffuse bronchiectasis, cystic fibrosis, chronic asthma (>15% reversibility), 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 (e.g., Pseudomonas aeruginosa, MRSA)
  • 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
  • Requiring intravenous antibiotic therapy for treatment of the current exacerbation
  • Unable to take oral medication
  • Life expectancy of less than 6 months
  • Receiving systemic antibacterial therapy within 30 days prior to study enrollment
  • Requiring concomitant systemic antibacterial agents
  • Use of any investigational drug or device within 30 days of screening, or previously enrolled in this study
  • Requiring home ventilatory support (subjects requiring home/portable oxygen therapy or CPAP for sleep apnea are not excluded) and/or those who have a tracheotomy in situ
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00656747

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

  Hide Study Locations
Locations
Andorra
Recruiting
Escaldes - Engordany, Andorra
Argentina, Buenos Aires
Recruiting
Vicente López, Buenos Aires, Argentina, B1602DOH
Recruiting
Quilmes, Buenos Aires, Argentina
Argentina, Buenos aires
Recruiting
Florencio Varela, Buenos aires, Argentina
Argentina, Capital Federal
Recruiting
Buenos Aires, Capital Federal, Argentina, C1425AWC
Terminated
Buenos Aires, Capital Federal, Argentina
Recruiting
Buenos Aires, Capital Federal, Argentina, 1426
Recruiting
Buenos Aires, Capital Federal, Argentina
Argentina, Tucumán
Recruiting
San Miguel de Tucumán, Tucumán, Argentina, 4000
Recruiting
San Miguel de Tucumán, Tucumán, Argentina
Australia, New South Wales
Not yet recruiting
Sydney, New South Wales, Australia, 2139
Australia, Queensland
Recruiting
Brisbane, Queensland, Australia, 4101
Australia, South Australia
Recruiting
Adelaide, South Australia, Australia, 5011
Recruiting
Adelaide, South Australia, Australia, 5041
Australia, Western Australia
Recruiting
Perth, Western Australia, Australia, 6009
Belgium
Not yet recruiting
YVOIR, Belgium, 5530
Recruiting
AALST, Belgium, 9300
Not yet recruiting
ANTWERPEN, Belgium, 2018
Recruiting
NAMUR, Belgium, 5000
Not yet recruiting
BRUXELLES - BRUSSEL, Belgium, 1020
Brazil, mg
Recruiting
Juiz de Fora, mg, Brazil, 36036-110
Brazil, RS
Recruiting
Porto Alegre, RS, Brazil, 90610-000
Brazil, SP
Not yet recruiting
Sao Paulo, SP, Brazil, 05403-900
Recruiting
Sao Paulo, SP, Brazil, 04023-900
Canada, Alberta
Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Recruiting
Calgary, Alberta, Canada, T2N 4N1
Recruiting
Edmonton, Alberta, Canada, T6L 5X8
Canada, British Columbia
Recruiting
Kelowna, British Columbia, Canada, V1Y 9L8
Recruiting
Vancouver, British Columbia, Canada, V5Z 4E1
Canada, Manitoba
Recruiting
Winnipeg, Manitoba, Canada, R3C 0N2
Terminated
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, New Brunswick
Terminated
St. John, New Brunswick, Canada, E2M 3W5
Not yet recruiting
St. John, New Brunswick, Canada, E2K 2T8
Canada, Nova Scotia
Recruiting
Antigonish, Nova Scotia, Canada, B2G 2C2
Recruiting
Sydney Mines, Nova Scotia, Canada, B1V 2Y5
Canada, Ontario
Not yet recruiting
London, Ontario, Canada, N6A 4V2
Not yet recruiting
Hamilton, Ontario, Canada, L8N 4A6
Not yet recruiting
Toronto, Ontario, Canada, M6H 3M2
Not yet recruiting
London, Ontario, Canada, N6A 5R9
Not yet recruiting
Burlington, Ontario, Canada, L7R 2H3
Canada, Quebec
Recruiting
Montreal, Quebec, Canada, H2L 4M1
Not yet recruiting
Sherbrooke, Quebec, Canada, JIH 4J6
Terminated
Longueuil, Quebec, Canada, J4N 1E1
Chile
Recruiting
Viña del Mar, Chile
Recruiting
Santiago, Chile
Recruiting
Valparaiso, Chile, 236-3058
Not yet recruiting
Santiago, Chile
Chile, V Region
Not yet recruiting
Viña del Mar, V Region, Chile
China
Recruiting
Shanghai, China, 200233
Recruiting
Shanghai, China, 200003
Recruiting
Shanghai, China, 200040
Recruiting
Tianjin, China, 300052
Recruiting
beijing, China, 100020
Recruiting
Beijing, China, 100050
China, Guangdong
Recruiting
Guangzhou, Guangdong, China, 510120
China, Liaoning
Recruiting
Shenyang, Liaoning, China, 11000
Recruiting
Shenyang, Liaoning, China, 110003
China, Sichuan
Recruiting
Chengdu, Sichuan, China, 610041
Colombia
Recruiting
Bogotá, Colombia
Not yet recruiting
Bogotá, Colombia
Not yet recruiting
Medellín, Colombia
Recruiting
Cali, Colombia
Not yet recruiting
Bucaramanga, Colombia
Recruiting
Medellín, Colombia
Colombia, Valle del Cauca
Not yet recruiting
Cali, Valle del Cauca, Colombia
Croatia
Not yet recruiting
Zagreb, Croatia, 10000
Not yet recruiting
Rijeka, Croatia, 510 00
Not yet recruiting
Petrinja, Croatia, 44 250
Not yet recruiting
Osijek, Croatia, 310 00
Czech Republic
Not yet recruiting
Praha - Malesice, Czech Republic, 108 00
Not yet recruiting
Kyjov, Czech Republic, 697 01
Not yet recruiting
Lovosice, Czech Republic, 410 02
Not yet recruiting
Neratovice, Czech Republic, 227 11
Not yet recruiting
Praha - Troja, Czech Republic, 182 00
Not yet recruiting
Pardubice - Trnova, Czech Republic, 530 09
France
Terminated
PERPIGNAN, France, 66025
Terminated
NICE, France, 06000
Terminated
MARSEILLE, France, 13009
Terminated
MONT-DE-MARSAN, France, 40000
Germany
Recruiting
Berlin, Germany, 10717
Terminated
Berlin, Germany, 12043
Recruiting
Berlin, Germany, 12203
Recruiting
Berlin, Germany, 10969
Recruiting
Hamburg, Germany, 20354
Not yet recruiting
Berlin, Germany, 13597
Recruiting
Berlin, Germany, 14059
Germany, Baden-Württemberg
Recruiting
Bad Dürrheim, Baden-Württemberg, Germany, 78073
Germany, Bayern
Terminated
Augsburg, Bayern, Germany, 86150
Germany, Brandenburg
Not yet recruiting
Rüdersdorf, Brandenburg, Germany, 15562
Recruiting
Cottbus, Brandenburg, Germany, 03050
Recruiting
Zossen, Brandenburg, Germany, 15806
Germany, Hessen
Recruiting
Fulda, Hessen, Germany, 36039
Terminated
Frankfurt, Hessen, Germany, 60318
Germany, Mecklenburg-Vorpommern
Terminated
Neubrandenburg, Mecklenburg-Vorpommern, Germany, 17033
Germany, Nordrhein-Westfalen
Recruiting
Lüdenscheid, Nordrhein-Westfalen, Germany, 58515
Germany, Rheinland-Pfalz
Not yet recruiting
Neuwied, Rheinland-Pfalz, Germany, 56564
Germany, Sachsen
Recruiting
Leipzig, Sachsen, Germany, 04357
Not yet recruiting
Dresden, Sachsen, Germany, 01307
Terminated
Leipzig, Sachsen, Germany, 04275
Not yet recruiting
Leipzig, Sachsen, Germany, 04207
Not yet recruiting
Delitzsch, Sachsen, Germany, 04509
Germany, Schleswig-Holstein
Recruiting
Bad Segeberg, Schleswig-Holstein, Germany, 23795
Recruiting
Lübeck, Schleswig-Holstein, Germany, 23552
Greece
Recruiting
Athens, Greece, 11527
Greece, Attica
Recruiting
Athens, Attica, Greece, 106 76
Greece, Ioannina
Recruiting
Dourouti-Ioannina, Ioannina, Greece, 45500
Greece, Larissa
Recruiting
Mezourlo, Larissa, Greece, 41110
Greece, Patras
Recruiting
Rio, Patras, Greece, 265 04
Hong Kong
Recruiting
New Territories, Hong Kong
Recruiting
Kowloon, Hong Kong
Indonesia
Recruiting
Jakarta, Indonesia
Recruiting
Bandung, Indonesia
Recruiting
Surabaya, Indonesia
Ireland, Co Kerry
Not yet recruiting
Killarney, Co Kerry, Ireland
Ireland, Co Longford
Not yet recruiting
Longford, Co Longford, Ireland
Ireland, Co Wexford
Terminated
Gorey, Co Wexford, Ireland
Recruiting
Enniscorthy, Co Wexford, Ireland
Not yet recruiting
Gorey, Co Wexford, Ireland
Ireland, Dublin
Not yet recruiting
Rathmines, Dublin, Ireland
Ireland, Wicklow
Not yet recruiting
Bray, Wicklow, Ireland
Italy
Recruiting
Chieti, Italy, 66100
Not yet recruiting
Milano, Italy, 20157
Recruiting
Ancona, Italy, 60100
Terminated
Perugia, Italy, 06156
Not yet recruiting
Catania, Italy, 95123
Italy, Salerno
Recruiting
Nocera Inferiore, Salerno, Italy, 84014
Italy, Varese
Recruiting
Busto Arsizio, Varese, Italy, 21052
Italy, Verona
Not yet recruiting
Bussolengo, Verona, Italy, 37012
Latvia
Not yet recruiting
Riga, Latvia, 1011
Terminated
Riga, Latvia, 1009
Not yet recruiting
Valmiera, Latvia, 4201
Recruiting
Ventspils, Latvia
Lithuania
Not yet recruiting
Vilnius, Lithuania, LT-07156
Recruiting
Vilnius, Lithuania, LT-06122
Recruiting
Kaunas, Lithuania, LT-50425
Recruiting
Kaunas, Lithuania
Recruiting
Klaipeda, Lithuania, LT-94231
Not yet recruiting
Siauliai, Lithuania, 76231
Mexico
Not yet recruiting
Chihuahua, Mexico, 31350
Not yet recruiting
Zacatecas, Mexico, 98608
Mexico, Edo. de Mexico
Not yet recruiting
Huixquilucan, Edo. de Mexico, Mexico, CP 52763
Mexico, Jalisco
Recruiting
Guadalajara, Jalisco, Mexico, 44280
Mexico, Nuevo León
Not yet recruiting
Monterrey, Nuevo León, Mexico, 66480
Not yet recruiting
Monterrey, Nuevo León, Mexico, 64718
Mexico, Yucatán
Not yet recruiting
Mérida, Yucatán, Mexico, 97001
Recruiting
Mérida, Yucatán, Mexico, 97001
Netherlands
Recruiting
HEERLEN, Netherlands, 6419 PC
Not yet recruiting
HOOFDDORP, Netherlands, 2134 TM
Not yet recruiting
MEPPEL, Netherlands, 7943 KA
Not yet recruiting
UTRECHT, Netherlands, 3582 KE
Netherlands, Noord Brabant
Recruiting
EINDHOVEN, Noord Brabant, Netherlands, 5623 EJ
Pakistan
Recruiting
Karachi, Pakistan, 75500
Terminated
Islamabad, Pakistan
Pakistan, Sindh
Terminated
Karachi, Sindh, Pakistan, 74800
Peru
Recruiting
Lima, Peru, 33
Not yet recruiting
Callao, Peru, CALLAO 2
Recruiting
Lima, Peru
Recruiting
Lima, Peru, LIMA 27
Not yet recruiting
Lima, Peru, 31
Not yet recruiting
Lima, Peru, LIMA 18
Philippines
Recruiting
Manila, Philippines, 1000
Recruiting
Quezon City, Philippines
Portugal
Terminated
Lisboa, Portugal, 1649-035
Not yet recruiting
Vila Nova de Gaia, Portugal, 4434-506
Not yet recruiting
Lisboa, Portugal, 1169-024
Terminated
Coimbra, Portugal, 3000-075
Not yet recruiting
Santarém, Portugal, 2005-177
Not yet recruiting
Torres Vedras, Portugal, 2560-324
Portugal, Coimbra
Not yet recruiting
S. Martinho do Bispo, Coimbra, Portugal, 3041-856
South Africa, Free State
Recruiting
Bloemfontein, Free State, South Africa, 9324
South Africa, Gauteng
Recruiting
Benoni, Gauteng, South Africa, 1500
Recruiting
Kempton Park, Gauteng, South Africa, 1610
Recruiting
Centurion, Gauteng, South Africa, 0140
Recruiting
Pretoria, Gauteng, South Africa
South Africa, KwaZulu Natal
Recruiting
Durban, KwaZulu Natal, South Africa, 4091
Not yet recruiting
Durban, KwaZulu Natal, South Africa, 4037
South Africa, Limpopo
Not yet recruiting
Thabazimbi, Limpopo, South Africa, 0380
South Africa, Mpumalanga
Recruiting
Witbank, Mpumalanga, South Africa, 1035
South Africa, Port Elizabert
Not yet recruiting
Korsten, Port Elizabert, South Africa, 6014
South Africa, Pretoria
Recruiting
Eloffsdal, Pretoria, South Africa, 0084
Not yet recruiting
Sunnyside, Pretoria, South Africa, 0002
South Africa, Western Cape
Recruiting
Paarl, Western Cape, South Africa, 7647
Recruiting
Cape Town, Western Cape, South Africa, 7505
Recruiting
Somerset West, Western Cape, South Africa, 7130
Spain
Not yet recruiting
Barcelona, Spain, 08034
Not yet recruiting
Barcelona, Spain, 08036
Terminated
Guadalajara, Spain, 19002
Not yet recruiting
Madrid, Spain, 28040
Recruiting
Palma de Mallorca, Spain, 07014
Spain, Barcelona
Recruiting
Badalona, Barcelona, Spain, 08916
Not yet recruiting
Sant Boi de Llobregat, Barcelona, Spain, 08830
Spain, Valencia
Recruiting
Requena, Valencia, Spain, 46340
Switzerland
Not yet recruiting
Wettingen, Switzerland, 5430
Not yet recruiting
Thun, Switzerland, 3600
Recruiting
Basel, Switzerland, 4031
Not yet recruiting
Zürich, Switzerland, 8048
Not yet recruiting
Zürich, Switzerland, 8091
Switzerland, Aargau
Not yet recruiting
Aarau, Aargau, Switzerland, 5000
Switzerland, Basel-Land
Terminated
Oberwil, Basel-Land, Switzerland, 4104
Switzerland, Basel-Landschaft
Terminated
Laufen, Basel-Landschaft, Switzerland, 4242
Switzerland, Basel-Stadt
Terminated
Binningen, Basel-Stadt, Switzerland, 4102
Thailand
Recruiting
Bangkok, Thailand, 10330
Recruiting
Chiangmai, Thailand, 50200
Recruiting
Nonthaburi, Thailand, 11000
United Kingdom, Strathclyde
Recruiting
Glasgow, Strathclyde, United Kingdom, G69 7AD
Terminated
Glasgow, Strathclyde, United Kingdom, G3 8YJ
Terminated
Glasgow, Strathclyde, United Kingdom
Recruiting
Glasgow, Strathclyde, United Kingdom, G46 8NY
Not yet recruiting
Glasgow, Strathclyde, United Kingdom, G45 9AW
United Kingdom, Warwickshire
Terminated
Coventry, Warwickshire, United Kingdom, CV7 8LA
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer HealthCare AG ( Medical Affairs Therapeutic Area Head )
Study ID Numbers: 11980, EudraCT: 2007-006096-37
Study First Received: April 4, 2008
Last Updated: September 30, 2009
ClinicalTrials.gov Identifier: NCT00656747     History of Changes
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: State Food and Drug Administration;   Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos;   Czech Republic: State Institute for Drug Control;   France: Afssaps - French Health Products Safety Agency;   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:
Acute Exacerbation of Chronic Bronchitis (AECB),
Chronic Bronchitis (CB),
Chronic Obstructive Pulmonary Disease (COPD)

Additional relevant MeSH terms:
Acute Disease
Anti-Infective Agents
Disease Attributes
Amoxicillin
Molecular Mechanisms of Pharmacological Action
Bronchial Diseases
Clavulanic Acids
Enzyme Inhibitors
Amoxicillin-Potassium Clavulanate Combination
Pharmacologic Actions
Anti-Bacterial Agents
Bronchitis, Chronic
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Moxifloxacin
Therapeutic Uses
Clavulanic Acid
Lung Diseases
Bronchitis
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on November 27, 2009