check_circleStudy Completed

Lung Diseases, Bronchitis, Chronic

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

Both

Age

45 - 90 Years
  • - Male or female out-patients >/= 45 years
    - Subjects suffering from chronic bronchitis
    - FEV1 - 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

  • - 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
October 2004 - January 2007
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Hospital Ntra. Sra. de MeritxellEscaldes - Engordany, Andorra
Completed
Hospital das Clínicas da Faculdade de Medicina da USPSao Paulo, 05403-900, Brazil
Completed
Hospital Nacional del TóraxSantiago, Chile
Terminated
DiakoniekrankenhausRotenburg, 27356, Germany
Completed
Tel Aviv Sourasky Medical CenterTel Aviv, 64239, Israel
Completed
Hosp. Municipal de Agudos "Mi Pueblo"Florencio Varela, 1888, Argentina
Completed
Hospital Universitari Germans Trias i PujolBadalona, 08916, Spain
Completed
Cabinet médical - Cronstadt - NiceNICE, 06000, France
Completed
St James' HospitalDublin, 8, Ireland
Completed
Haemek Medical CenterAfula, 18101, Israel
Completed
Ospedale San Giuseppe FbF Polo UniversitarioMilano, 20123, Italy
Completed
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"Guadalajara, 44280, Mexico
Completed
Clinica AvansaludSantiago, Chile
Completed
Cabinet Médical - Madame - OrthezORTHEZ, 64300, France
Completed
Southmead HospitalBristol, BS10 5NB, United Kingdom
Completed
Hospital de Clínicas "José de San Martín"Buenos Aires, C1120AAF, Argentina
Completed
Hospital Clínic i Provincial de BarcelonaBarcelona, 08036, Spain
Completed
Cabinet Médical - Martinon - Mont de MarsanMONT-DE-MARSAN, 40000, France
Terminated
London Chest HospitalLondon, E2 9JX, United Kingdom
Terminated
Mater Misericordiae University HospitalDublin, DUBLIN 7, Ireland
Completed
IRCCS Policlinico San MatteoPavia, 27100, Italy
Completed
Hospital Central UniversitarioChihuahua, 31350, Mexico
Completed
Veterans Affairs Medical CenterHouston, 77030, United States
Completed
WilMed Medical Research ProjectsPretoria, 0040, South Africa
Completed
UNIFESP/EPMSao Paulo, 04023-900, Brazil
Completed
Hospital Carlos van BurenValparaiso, 236-3058, Chile
Completed
Pneumologisches Forschungsinstitut GmbHHamburg, 20535, Germany
Completed
St James' HospitalLeeds, LS9 7TF, United Kingdom
Completed
VA Long Beach Healthcare SystemLong Beach, 90822-5201, United States
Completed
Unitas HospitalPretoria, 0157, South Africa
Completed
Maccabbi Sick FundBat Yam, 59512, Israel
Completed
A.O. Sacco Polo UniversitarioMilano, 20157, Italy
Completed
Southern Arizona Veterans Affairs Health Care SystemTucson, 85723, United States
Completed
Hospital Militar Central "CIR. MY. C. Argerich"Buenos Aires, 1426, Argentina
Completed
Universidade Federal de Juiz de Fora- Hospital UniversitarioJuiz de Fora, 36036-110, Brazil
Completed
Praxis Drs. Westerhausen/Pettenkofer/KlüppelbergBerlin, 10969, Germany
Completed
Hospital Clínico Universitario San CarlosMadrid, 28040, Spain
Completed
Cabinet Médical - Tauler - StrasbourgSTRASBOURG, 67000, France
Terminated
Royal Brompton HospitalLondon, SW3 6NP, United Kingdom
Completed
The Barzilai Medical Center AshkelonAshkelon, 78306, Israel
Completed
South Texas Veterans Health Care SystemSan Antonio, 78284-5799, United States
Completed
Genclin CorporationBloemfontein, 9301, South Africa
Completed
DRK Krankenhaus NeuwiedNeuwied, 56564, Germany
Completed
Hospital del Rio HortegaValladolid, 47010, Spain
Completed
Praxis Hr. Dr. A. ColbergBad Segeberg, 23795, Germany
Completed
Policlínico BancarioBuenos Aires, 1416, Argentina
Completed
Pontificia Universidade Católica - Centro ClínicoPorto Alegre, 90610-000, Brazil
Completed
Praxis Hr. Dr. B. KroemerKaufbeuren, 87600, Germany
Completed
Hospital Universitario La FeValencia, 46009, Spain
Completed
Hospital General Regional N°. 12 "Lic. Benito Juárez" IMSSMérida, 97070, Mexico
Completed
Morningside Clinic Rocherster PlaceJohannesburg, 2057, South Africa
Completed
A.O.U. di FerraraFerrara, 44100, Italy
Completed
Clínica MéridaMérida, 97001, Mexico
Completed
Cabinet Médical - Bourg - Rosiers d'EgletonsROSIERS D'EGLETONS, 19300, France
Completed
St George's HospitalLondon, SW17 0QT, United Kingdom
Completed
Centro Médico de las AméricasMérida, 97001, Mexico
Completed
Kansas City VA Medical CenterKansas City, 64128-2295, United States
Terminated
Parklands Medical Centre - DurbanDurban, 4091, South Africa
Completed
Hospital de la SerraníaRonda, 29400, Spain
Completed
Cabinet Médical - Novembre - ArrasARRAS, 62000, France
Completed
Tiervlei Trial CentreCape Town, 7531, South Africa
Completed
Queen Elizabeth HospitalBirmingham, B15 2TH, United Kingdom
Completed
Praxis Hr. Dr. R. DichmannWitten, 58452, Germany
Completed
Royal Free HospitalLondon, NW3 2QG, United Kingdom
Completed
Universitas HospitalBloemfontein, 9300, South Africa
Completed
Clinical Trial CenterPaarl, 7646, South Africa
Completed
Praxis fü Lungen- und Bronchialheilkunde,Berlin, 10717, Germany
Completed
Praxis Hr. Dr. W. Schröder-BaboGelnhausen, 63571, Germany
Terminated
Office of Dr. F. Adam Kawley, MDHouston, 77024, United States
Completed
Sotiria General State Hospital of Chest DiseasesAthens, 11527, Greece
Completed
University General Hospital of PatrasRio, 265 04, Greece
Completed
Clinical Research CentreLondon, E1 2AT, United Kingdom
Completed
McGuire Veterans Affairs Medical CenterRichmond, 23249-0002, United States
Completed
Praxis Drs. Leonhardt/MolitorHannover, 30159, Germany
Completed
Cabinet Médical - 22 Gounod - NiceNICE, 06000, France
Completed
Bay Pines VA Healthcare SystemBay Pines, 33744, United States
Completed
Kraaifontein Medicross ClinicCape Town, 7569, South Africa
Completed
VA North Texas Healthcare SystemDallas, 75216-7167, United States
Completed
Praxis Hr. Dr. R. GebhardtBerlin, 12043, Germany
Completed
VA Western NY Healthcare SystemBuffalo, 14215-1129, United States
Completed
VA Greater Los Angeles Healthcare SystemLos Angeles, 90073-1003, United States
Completed
Sotiria General State Hospital of Chest DiseasesAthens, 11527, Greece

Primary Outcome

  • Number of exacerbations after 48 weeks of intermittent pulse treatment
    date_rangeTime Frame:
    After 48 weeks of treatment
    enhanced_encryption
    Safety Issue:
    None

Secondary Outcome

  • Impact of treatment on the health related Quality of Life in St. George's Respiratory Questionaire (SGRQ) scores
    date_rangeTime Frame:
    At week 48
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    Safety Issue:
    None
  • Deterioration in lung function test (PFEV1)
    date_rangeTime Frame:
    At week 48
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    Safety Issue:
    None
  • Frequency of hospitalisation
    date_rangeTime Frame:
    At week 48
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    Safety Issue:
    None
  • Mortality rates
    date_rangeTime Frame:
    At week 48
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    Safety Issue:
    None
  • Time of first exacerbation
    date_rangeTime Frame:
    Through to week 48
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    Safety Issue:
    None
  • Frequency of acute exacerbation of chronic bronchitis
    date_rangeTime Frame:
    At week 24 and 72 (end of follow-up)
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    Safety Issue:
    None
  • Time to next exacerbation from last pulsed dose
    date_rangeTime Frame:
    At week 48
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    Safety Issue:
    None
  • Length of exacerbations
    date_rangeTime Frame:
    Through to week 48
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    Safety Issue:
    None
  • Percentage of exacerbation free time
    date_rangeTime Frame:
    Through to week 48
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    Safety Issue:
    None

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