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