check_circleStudy Completed
Lung Diseases, Bronchitis, Chronic
Bayer Identifier:
11229
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Intermittent Moxifloxacin Therapy For The Prevention Of Acute Exacerbations In Patients With Chronic Bronchitis
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.
Key Participants Requirements
Sex
BothAge
45 - 90 YearsTrial summary
Enrollment Goal
1404Trial Dates
October 2004 - January 2007Phase
Phase 3Could I Receive a placebo
YesProducts
Avelox (Moxifloxacin hydrochloride, BAY12-8039)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Hospital Ntra. Sra. de Meritxell | Escaldes - Engordany, Andorra |
Completed | Hospital das Clínicas da Faculdade de Medicina da USP | Sao Paulo, 05403-900, Brazil |
Completed | Hospital Nacional del Tórax | Santiago, Chile |
Terminated | Diakoniekrankenhaus | Rotenburg, 27356, Germany |
Completed | Tel Aviv Sourasky Medical Center | Tel Aviv, 64239, Israel |
Completed | Hosp. Municipal de Agudos "Mi Pueblo" | Florencio Varela, 1888, Argentina |
Completed | Hospital Universitari Germans Trias i Pujol | Badalona, 08916, Spain |
Completed | Cabinet médical - Cronstadt - Nice | NICE, 06000, France |
Completed | St James' Hospital | Dublin, 8, Ireland |
Completed | Haemek Medical Center | Afula, 18101, Israel |
Completed | Ospedale San Giuseppe FbF Polo Universitario | Milano, 20123, Italy |
Completed | Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde" | Guadalajara, 44280, Mexico |
Completed | Clinica Avansalud | Santiago, Chile |
Completed | Cabinet Médical - Madame - Orthez | ORTHEZ, 64300, France |
Completed | Southmead Hospital | Bristol, BS10 5NB, United Kingdom |
Completed | Hospital de Clínicas "José de San Martín" | Buenos Aires, C1120AAF, Argentina |
Completed | Hospital Clínic i Provincial de Barcelona | Barcelona, 08036, Spain |
Completed | Cabinet Médical - Martinon - Mont de Marsan | MONT-DE-MARSAN, 40000, France |
Terminated | London Chest Hospital | London, E2 9JX, United Kingdom |
Terminated | Mater Misericordiae University Hospital | Dublin, DUBLIN 7, Ireland |
Completed | IRCCS Policlinico San Matteo | Pavia, 27100, Italy |
Completed | Hospital Central Universitario | Chihuahua, 31350, Mexico |
Completed | Veterans Affairs Medical Center | Houston, 77030, United States |
Completed | WilMed Medical Research Projects | Pretoria, 0040, South Africa |
Completed | UNIFESP/EPM | Sao Paulo, 04023-900, Brazil |
Completed | Hospital Carlos van Buren | Valparaiso, 236-3058, Chile |
Completed | Pneumologisches Forschungsinstitut GmbH | Hamburg, 20535, Germany |
Completed | St James' Hospital | Leeds, LS9 7TF, United Kingdom |
Completed | VA Long Beach Healthcare System | Long Beach, 90822-5201, United States |
Completed | Unitas Hospital | Pretoria, 0157, South Africa |
Completed | Maccabbi Sick Fund | Bat Yam, 59512, Israel |
Completed | A.O. Sacco Polo Universitario | Milano, 20157, Italy |
Completed | Southern Arizona Veterans Affairs Health Care System | Tucson, 85723, United States |
Completed | Hospital Militar Central "CIR. MY. C. Argerich" | Buenos Aires, 1426, Argentina |
Completed | Universidade Federal de Juiz de Fora- Hospital Universitario | Juiz de Fora, 36036-110, Brazil |
Completed | Praxis Drs. Westerhausen/Pettenkofer/Klüppelberg | Berlin, 10969, Germany |
Completed | Hospital Clínico Universitario San Carlos | Madrid, 28040, Spain |
Completed | Cabinet Médical - Tauler - Strasbourg | STRASBOURG, 67000, France |
Terminated | Royal Brompton Hospital | London, SW3 6NP, United Kingdom |
Completed | The Barzilai Medical Center Ashkelon | Ashkelon, 78306, Israel |
Completed | South Texas Veterans Health Care System | San Antonio, 78284-5799, United States |
Completed | Genclin Corporation | Bloemfontein, 9301, South Africa |
Completed | DRK Krankenhaus Neuwied | Neuwied, 56564, Germany |
Completed | Hospital del Rio Hortega | Valladolid, 47010, Spain |
Completed | Praxis Hr. Dr. A. Colberg | Bad Segeberg, 23795, Germany |
Completed | Policlínico Bancario | Buenos Aires, 1416, Argentina |
Completed | Pontificia Universidade Católica - Centro Clínico | Porto Alegre, 90610-000, Brazil |
Completed | Praxis Hr. Dr. B. Kroemer | Kaufbeuren, 87600, Germany |
Completed | Hospital Universitario La Fe | Valencia, 46009, Spain |
Completed | Hospital General Regional N°. 12 "Lic. Benito Juárez" IMSS | Mérida, 97070, Mexico |
Completed | Morningside Clinic Rocherster Place | Johannesburg, 2057, South Africa |
Completed | A.O.U. di Ferrara | Ferrara, 44100, Italy |
Completed | Clínica Mérida | Mérida, 97001, Mexico |
Completed | Cabinet Médical - Bourg - Rosiers d'Egletons | ROSIERS D'EGLETONS, 19300, France |
Completed | St George's Hospital | London, SW17 0QT, United Kingdom |
Completed | Centro Médico de las Américas | Mérida, 97001, Mexico |
Completed | Kansas City VA Medical Center | Kansas City, 64128-2295, United States |
Terminated | Parklands Medical Centre - Durban | Durban, 4091, South Africa |
Completed | Hospital de la Serranía | Ronda, 29400, Spain |
Completed | Cabinet Médical - Novembre - Arras | ARRAS, 62000, France |
Completed | Tiervlei Trial Centre | Cape Town, 7531, South Africa |
Completed | Queen Elizabeth Hospital | Birmingham, B15 2TH, United Kingdom |
Completed | Praxis Hr. Dr. R. Dichmann | Witten, 58452, Germany |
Completed | Royal Free Hospital | London, NW3 2QG, United Kingdom |
Completed | Universitas Hospital | Bloemfontein, 9300, South Africa |
Completed | Clinical Trial Center | Paarl, 7646, South Africa |
Completed | Praxis fü Lungen- und Bronchialheilkunde, | Berlin, 10717, Germany |
Completed | Praxis Hr. Dr. W. Schröder-Babo | Gelnhausen, 63571, Germany |
Terminated | Office of Dr. F. Adam Kawley, MD | Houston, 77024, United States |
Completed | Sotiria General State Hospital of Chest Diseases | Athens, 11527, Greece |
Completed | University General Hospital of Patras | Rio, 265 04, Greece |
Completed | Clinical Research Centre | London, E1 2AT, United Kingdom |
Completed | McGuire Veterans Affairs Medical Center | Richmond, 23249-0002, United States |
Completed | Praxis Drs. Leonhardt/Molitor | Hannover, 30159, Germany |
Completed | Cabinet Médical - 22 Gounod - Nice | NICE, 06000, France |
Completed | Bay Pines VA Healthcare System | Bay Pines, 33744, United States |
Completed | Kraaifontein Medicross Clinic | Cape Town, 7569, South Africa |
Completed | VA North Texas Healthcare System | Dallas, 75216-7167, United States |
Completed | Praxis Hr. Dr. R. Gebhardt | Berlin, 12043, Germany |
Completed | VA Western NY Healthcare System | Buffalo, 14215-1129, United States |
Completed | VA Greater Los Angeles Healthcare System | Los Angeles, 90073-1003, United States |
Completed | Sotiria General State Hospital of Chest Diseases | Athens, 11527, Greece |
Primary Outcome
- Number of exacerbations after 48 weeks of intermittent pulse treatmentdate_rangeTime Frame:After 48 weeks of treatmentenhanced_encryptionNoneSafety Issue:
Secondary Outcome
- Impact of treatment on the health related Quality of Life in St. George's Respiratory Questionaire (SGRQ) scoresdate_rangeTime Frame:At week 48enhanced_encryptionNoneSafety Issue:
- Deterioration in lung function test (PFEV1)date_rangeTime Frame:At week 48enhanced_encryptionNoneSafety Issue:
- Frequency of hospitalisationdate_rangeTime Frame:At week 48enhanced_encryptionNoneSafety Issue:
- Mortality ratesdate_rangeTime Frame:At week 48enhanced_encryptionNoneSafety Issue:
- Time of first exacerbationdate_rangeTime Frame:Through to week 48enhanced_encryptionNoneSafety Issue:
- Frequency of acute exacerbation of chronic bronchitisdate_rangeTime Frame:At week 24 and 72 (end of follow-up)enhanced_encryptionNoneSafety Issue:
- Time to next exacerbation from last pulsed dosedate_rangeTime Frame:At week 48enhanced_encryptionNoneSafety Issue:
- Length of exacerbationsdate_rangeTime Frame:Through to week 48enhanced_encryptionNoneSafety Issue:
- Percentage of exacerbation free timedate_rangeTime Frame:Through to week 48enhanced_encryptionNoneSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
PreventionAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2Additional Information
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