Trial Condition(s):

Lung Diseases, Bronchitis, Chronic

Intermittent Moxifloxacin Therapy For The Prevention Of Acute Exacerbations In Patients With Chronic Bronchitis

Bayer Identifier:

11229

ClinicalTrials.gov Identifier:

NCT00473460

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial Purpose

Moxifloxacin, is being tested at approximately 60 study centres in 15 countries to determine if this drug, when taken periodically in addition to the patients normal treatment, is effective at reducing the number of flare-ups of chronic bronchitis he has. Approximately 1132 subjects will participate, and it is expected that the study will run for 2 years in order to reach that goal. The patients individual involvement in the study will be 17 months. Moxifloxacin will be compared to a placebo drug (no active ingredients). The study medication (moxifloxacin or placebo) will be taken in addition to the patients normal medication for chronic bronchitis. In addition to the first clinic visit, called a screening visit, the patient will be required to come back to the clinic for ten more study visits, every 8 weeks. At the first visit the study co-ordinator will provide him with the dates for all the visits. Over a period of 48 weeks the patient will return to the clinic on 6 occasions where he will receive the study medication which he will take for five days, in addition to his normal treatment for chronic bronchitis. After this time the patient will enter a follow up period for 24 weeks, where he will come to the clinic for assessments and continue to take his normal medication but not receive the study drug. A complete medical history will be taken at the first visit, including the patients past and current smoking habit. A breath test will be performed to assess how well his lungs are functioning. In addition, he will also be asked to provide a sputum sample for a microbiological examination to identify any bacteria present in the sample. The patient must be able to provide a sputum sample at the screening visit. If the patient meets all the inclusion / exclusion criteria for the study, he will be allocated randomly to one of the following treatment groups at the second visit.- Treatment group 1: Receives moxifloxacin orally once daily for five days.- Treatment group 2: Receives a matching placebo once daily for five days.In between each visit (four weeks after your clinic visit), the study site co-ordinator will contact the patient to check on his well being. If the patient or the doctor decides to stop the patients participation in the trial for any reason, the patient will be required to return to the clinic for a physical examination, take a breath test, provide a sputum sample (if possible) and have a blood sample taken.

Inclusion Criteria
- Male or female out-patients >/= 45 years
 - Subjects suffering from chronic bronchitis
 - FEV1</= 70% and FEV1/FVC </= 70% predicted from age, height and sex
 - No documented episode of AECB (requiring treatment) within 6 weeks of randomization and not experiencing an exacerbation at the time of screening
 - Sputum production on most days, even when exacerbation free
 - Subjects presented with at least two documented (i.e. requiring antibiotics and/or systemic steroid administration) acute exacerbation episodes during the last 12 monthsIf receiving chronic therapy with inhaled long acting bronchodilators and/or inhaled or systemic steroids, the treatment must have remained stable for the preceding 6 weeks prior to screening
 - Smoking history of at least 20 pack-years
 - Subjects willing and able to give fully informed written consent
Exclusion Criteria
- Subjects with contra-indications to moxifloxacin- Known bronchial carcinoma, pulmonary tuberculosis, cystic fibrosis, documented chronic bronchial asthma or diffuse bronchiectasis- Subjects who are actively participating in intensive pulmonary rehabilitation programs
 - Subjects with a known history of chronic colonization of pathogenic organisms resistant to moxifloxacin, e.g. Pseudomonas spp, MRSA
 - No systemic or inhaled antibiotic therapy during the 6 weeks prior to screening and any long term antibiotic usage
 - Subjects requiring home ventilatory support for COPD and those who have a tracheostomy in situ (subjects requiring home/potable oxygen therapy or CPAP for sleep apnea can be included)

Trial Summary

Enrollment Goal
1404
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
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Hospital Ntra. Sra. de Meritxell

Escaldes - Engordany, Andorra

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Hospital das Clínicas da Faculdade de Medicina da USP

Sao Paulo, Brazil, 05403-900

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Hospital Nacional del Tórax

Santiago, Chile

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Diakoniekrankenhaus

Rotenburg, Germany, 27356

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Tel Aviv Sourasky Medical Center

Tel Aviv, Israel, 64239

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Hosp. Municipal de Agudos "Mi Pueblo"

Florencio Varela, Argentina, 1888

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Hospital Universitari Germans Trias i Pujol

Badalona, Spain, 08916

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Cabinet médical - Cronstadt - Nice

NICE, France, 06000

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St James' Hospital

Dublin, Ireland, 8

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Haemek Medical Center

Afula, Israel, 18101

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Ospedale San Giuseppe FbF Polo Universitario

Milano, Italy, 20123

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Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Guadalajara, Mexico, 44280

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Clinica Avansalud

Santiago, Chile

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Cabinet Médical - Madame - Orthez

ORTHEZ, France, 64300

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Southmead Hospital

Bristol, United Kingdom, BS10 5NB

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Hospital de Clínicas "José de San Martín"

Buenos Aires, Argentina, C1120AAF

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Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

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Cabinet Médical - Martinon - Mont de Marsan

MONT-DE-MARSAN, France, 40000

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London Chest Hospital

London, United Kingdom, E2 9JX

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Mater Misericordiae University Hospital

Dublin, Ireland, DUBLIN 7

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IRCCS Policlinico San Matteo

Pavia, Italy, 27100

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Hospital Central Universitario

Chihuahua, Mexico, 31350

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Veterans Affairs Medical Center

Houston, United States, 77030

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WilMed Medical Research Projects

Pretoria, South Africa, 0040

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UNIFESP/EPM

Sao Paulo, Brazil, 04023-900

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Hospital Carlos van Buren

Valparaiso, Chile, 236-3058

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Pneumologisches Forschungsinstitut GmbH

Hamburg, Germany, 20535

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St James' Hospital

Leeds, United Kingdom, LS9 7TF

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VA Long Beach Healthcare System

Long Beach, United States, 90822-5201

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Unitas Hospital

Pretoria, South Africa, 0157

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Maccabbi Sick Fund

Bat Yam, Israel, 59512

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A.O. Sacco Polo Universitario

Milano, Italy, 20157

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Southern Arizona Veterans Affairs Health Care System

Tucson, United States, 85723

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Hospital Militar Central "CIR. MY. C. Argerich"

Buenos Aires, Argentina, 1426

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Universidade Federal de Juiz de Fora- Hospital Universitario

Juiz de Fora, Brazil, 36036-110

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Praxis Drs. Westerhausen/Pettenkofer/Klüppelberg

Berlin, Germany, 10969

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Hospital Clínico Universitario San Carlos

Madrid, Spain, 28040

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Cabinet Médical - Tauler - Strasbourg

STRASBOURG, France, 67000

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Royal Brompton Hospital

London, United Kingdom, SW3 6NP

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The Barzilai Medical Center Ashkelon

Ashkelon, Israel, 78306

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South Texas Veterans Health Care System

San Antonio, United States, 78284-5799

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Genclin Corporation

Bloemfontein, South Africa, 9301

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DRK Krankenhaus Neuwied

Neuwied, Germany, 56564

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Hospital del Rio Hortega

Valladolid, Spain, 47010

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Praxis Hr. Dr. A. Colberg

Bad Segeberg, Germany, 23795

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Policlínico Bancario

Buenos Aires, Argentina, 1416

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Pontificia Universidade Católica - Centro Clínico

Porto Alegre, Brazil, 90610-000

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Praxis Hr. Dr. B. Kroemer

Kaufbeuren, Germany, 87600

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Hospital Universitario La Fe

Valencia, Spain, 46009

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Hospital General Regional N°. 12 "Lic. Benito Juárez" IMSS

Mérida, Mexico, 97070

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Morningside Clinic Rocherster Place

Johannesburg, South Africa, 2057

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A.O.U. di Ferrara

Ferrara, Italy, 44100

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Clínica Mérida

Mérida, Mexico, 97001

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Cabinet Médical - Bourg - Rosiers d'Egletons

ROSIERS D'EGLETONS, France, 19300

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St George's Hospital

London, United Kingdom, SW17 0QT

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Centro Médico de las Américas

Mérida, Mexico, 97001

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Kansas City VA Medical Center

Kansas City, United States, 64128-2295

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Parklands Medical Centre - Durban

Durban, South Africa, 4091

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Hospital de la Serranía

Ronda, Spain, 29400

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Cabinet Médical - Novembre - Arras

ARRAS, France, 62000

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Tiervlei Trial Centre

Cape Town, South Africa, 7531

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Queen Elizabeth Hospital

Birmingham, United Kingdom, B15 2TH

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Praxis Hr. Dr. R. Dichmann

Witten, Germany, 58452

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Royal Free Hospital

London, United Kingdom, NW3 2QG

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Universitas Hospital

Bloemfontein, South Africa, 9300

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Clinical Trial Center

Paarl, South Africa, 7646

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Praxis fü Lungen- und Bronchialheilkunde,

Berlin, Germany, 10717

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Praxis Hr. Dr. W. Schröder-Babo

Gelnhausen, Germany, 63571

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Office of Dr. F. Adam Kawley, MD

Houston, United States, 77024

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Sotiria General State Hospital of Chest Diseases

Athens, Greece, 11527

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University General Hospital of Patras

Rio, Greece, 265 04

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Clinical Research Centre

London, United Kingdom, E1 2AT

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McGuire Veterans Affairs Medical Center

Richmond, United States, 23249-0002

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Praxis Drs. Leonhardt/Molitor

Hannover, Germany, 30159

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Cabinet Médical - 22 Gounod - Nice

NICE, France, 06000

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Bay Pines VA Healthcare System

Bay Pines, United States, 33744

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Kraaifontein Medicross Clinic

Cape Town, South Africa, 7569

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VA North Texas Healthcare System

Dallas, United States, 75216-7167

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Praxis Hr. Dr. R. Gebhardt

Berlin, Germany, 12043

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VA Western NY Healthcare System

Buffalo, United States, 14215-1129

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VA Greater Los Angeles Healthcare System

Los Angeles, United States, 90073-1003

Trial Design