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

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
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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
Status
LocationsStatus
Locations

Hospital Ntra. Sra. de Meritxell

Escaldes - Engordany, Andorra

Status
Completed
 
Locations

Hospital das Clínicas da Faculdade de Medicina da USP

Sao Paulo, Brazil, 05403-900

Status
Completed
 
Locations

Hospital Nacional del Tórax

Santiago, Chile

Status
Completed
 
Locations

Diakoniekrankenhaus

Rotenburg, Germany, 27356

Status
Terminated
 
Locations

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel, 64239

Status
Completed
 
Locations

Hosp. Municipal de Agudos "Mi Pueblo"

Florencio Varela, Argentina, 1888

Status
Completed
 
Locations

Hospital Universitari Germans Trias i Pujol

Badalona, Spain, 08916

Status
Completed
 
Locations

Cabinet médical - Cronstadt - Nice

NICE, France, 06000

Status
Completed
 
Locations

St James' Hospital

Dublin, Ireland, 8

Status
Completed
 
Locations

Haemek Medical Center

Afula, Israel, 18101

Status
Completed
 
Locations

Ospedale San Giuseppe FbF Polo Universitario

Milano, Italy, 20123

Status
Completed
 
Locations

Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Guadalajara, Mexico, 44280

Status
Completed
 
Locations

Clinica Avansalud

Santiago, Chile

Status
Completed
 
Locations

Cabinet Médical - Madame - Orthez

ORTHEZ, France, 64300

Status
Completed
 
Locations

Southmead Hospital

Bristol, United Kingdom, BS10 5NB

Status
Completed
 
Locations

Hospital de Clínicas "José de San Martín"

Buenos Aires, Argentina, C1120AAF

Status
Completed
 
Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

Status
Completed
 
Locations

Cabinet Médical - Martinon - Mont de Marsan

MONT-DE-MARSAN, France, 40000

Status
Completed
 
Locations

London Chest Hospital

London, United Kingdom, E2 9JX

Status
Terminated
 
Locations

Mater Misericordiae University Hospital

Dublin, Ireland, DUBLIN 7

Status
Terminated
 
Locations

IRCCS Policlinico San Matteo

Pavia, Italy, 27100

Status
Completed
 
Locations

Hospital Central Universitario

Chihuahua, Mexico, 31350

Status
Completed
 
Locations

Veterans Affairs Medical Center

Houston, United States, 77030

Status
Completed
 
Locations

WilMed Medical Research Projects

Pretoria, South Africa, 0040

Status
Completed
 
Locations

UNIFESP/EPM

Sao Paulo, Brazil, 04023-900

Status
Completed
 
Locations

Hospital Carlos van Buren

Valparaiso, Chile, 236-3058

Status
Completed
 
Locations

Pneumologisches Forschungsinstitut GmbH

Hamburg, Germany, 20535

Status
Completed
 
Locations

St James' Hospital

Leeds, United Kingdom, LS9 7TF

Status
Completed
 
Locations

VA Long Beach Healthcare System

Long Beach, United States, 90822-5201

Status
Completed
 
Locations

Unitas Hospital

Pretoria, South Africa, 0157

Status
Completed
 
Locations

Maccabbi Sick Fund

Bat Yam, Israel, 59512

Status
Completed
 
Locations

A.O. Sacco Polo Universitario

Milano, Italy, 20157

Status
Completed
 
Locations

Southern Arizona Veterans Affairs Health Care System

Tucson, United States, 85723

Status
Completed
 
Locations

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

Buenos Aires, Argentina, 1426

Status
Completed
 
Locations

Universidade Federal de Juiz de Fora- Hospital Universitario

Juiz de Fora, Brazil, 36036-110

Status
Completed
 
Locations

Praxis Drs. Westerhausen/Pettenkofer/Klüppelberg

Berlin, Germany, 10969

Status
Completed
 
Locations

Hospital Clínico Universitario San Carlos

Madrid, Spain, 28040

Status
Completed
 
Locations

Cabinet Médical - Tauler - Strasbourg

STRASBOURG, France, 67000

Status
Completed
 
Locations

Royal Brompton Hospital

London, United Kingdom, SW3 6NP

Status
Terminated
 
Locations

The Barzilai Medical Center Ashkelon

Ashkelon, Israel, 78306

Status
Completed
 
Locations

South Texas Veterans Health Care System

San Antonio, United States, 78284-5799

Status
Completed
 
Locations

Genclin Corporation

Bloemfontein, South Africa, 9301

Status
Completed
 
Locations

DRK Krankenhaus Neuwied

Neuwied, Germany, 56564

Status
Completed
 
Locations

Hospital del Rio Hortega

Valladolid, Spain, 47010

Status
Completed
 
Locations

Praxis Hr. Dr. A. Colberg

Bad Segeberg, Germany, 23795

Status
Completed
 
Locations

Policlínico Bancario

Buenos Aires, Argentina, 1416

Status
Completed
 
Locations

Pontificia Universidade Católica - Centro Clínico

Porto Alegre, Brazil, 90610-000

Status
Completed
 
Locations

Praxis Hr. Dr. B. Kroemer

Kaufbeuren, Germany, 87600

Status
Completed
 
Locations

Hospital Universitario La Fe

Valencia, Spain, 46009

Status
Completed
 
Locations

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

Mérida, Mexico, 97070

Status
Completed
 
Locations

Morningside Clinic Rocherster Place

Johannesburg, South Africa, 2057

Status
Completed
 
Locations

A.O.U. di Ferrara

Ferrara, Italy, 44100

Status
Completed
 
Locations

Clínica Mérida

Mérida, Mexico, 97001

Status
Completed
 
Locations

Cabinet Médical - Bourg - Rosiers d'Egletons

ROSIERS D'EGLETONS, France, 19300

Status
Completed
 
Locations

St George's Hospital

London, United Kingdom, SW17 0QT

Status
Completed
 
Locations

Centro Médico de las Américas

Mérida, Mexico, 97001

Status
Completed
 
Locations

Kansas City VA Medical Center

Kansas City, United States, 64128-2295

Status
Completed
 
Locations

Parklands Medical Centre - Durban

Durban, South Africa, 4091

Status
Terminated
 
Locations

Hospital de la Serranía

Ronda, Spain, 29400

Status
Completed
 
Locations

Cabinet Médical - Novembre - Arras

ARRAS, France, 62000

Status
Completed
 
Locations

Tiervlei Trial Centre

Cape Town, South Africa, 7531

Status
Completed
 
Locations

Queen Elizabeth Hospital

Birmingham, United Kingdom, B15 2TH

Status
Completed
 
Locations

Praxis Hr. Dr. R. Dichmann

Witten, Germany, 58452

Status
Completed
 
Locations

Royal Free Hospital

London, United Kingdom, NW3 2QG

Status
Completed
 
Locations

Universitas Hospital

Bloemfontein, South Africa, 9300

Status
Completed
 
Locations

Clinical Trial Center

Paarl, South Africa, 7646

Status
Completed
 
Locations

Praxis fü Lungen- und Bronchialheilkunde,

Berlin, Germany, 10717

Status
Completed
 
Locations

Praxis Hr. Dr. W. Schröder-Babo

Gelnhausen, Germany, 63571

Status
Completed
 
Locations

Office of Dr. F. Adam Kawley, MD

Houston, United States, 77024

Status
Terminated
 
Locations

Sotiria General State Hospital of Chest Diseases

Athens, Greece, 11527

Status
Completed
 
Locations

University General Hospital of Patras

Rio, Greece, 265 04

Status
Completed
 
Locations

Clinical Research Centre

London, United Kingdom, E1 2AT

Status
Completed
 
Locations

McGuire Veterans Affairs Medical Center

Richmond, United States, 23249-0002

Status
Completed
 
Locations

Praxis Drs. Leonhardt/Molitor

Hannover, Germany, 30159

Status
Completed
 
Locations

Cabinet Médical - 22 Gounod - Nice

NICE, France, 06000

Status
Completed
 
Locations

Bay Pines VA Healthcare System

Bay Pines, United States, 33744

Status
Completed
 
Locations

Kraaifontein Medicross Clinic

Cape Town, South Africa, 7569

Status
Completed
 
Locations

VA North Texas Healthcare System

Dallas, United States, 75216-7167

Status
Completed
 
Locations

Praxis Hr. Dr. R. Gebhardt

Berlin, Germany, 12043

Status
Completed
 
Locations

VA Western NY Healthcare System

Buffalo, United States, 14215-1129

Status
Completed
 
Locations

VA Greater Los Angeles Healthcare System

Los Angeles, United States, 90073-1003

Status
Completed
 

Trial Design