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Intermittent Moxifloxacin Therapy For The Prevention Of Acute Exacerbations In Patients With Chronic Bronchitis
This study has been completed.
First Received: May 14, 2007   Last Updated: June 29, 2009   History of Changes
Sponsor: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00473460
  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.

Condition Intervention Phase
Lung Diseases
Bronchitis, Chronic
Drug: Avelox (Moxifloxacin, BAY12-8039)
Drug: Placebo
Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of exacerbations after 48 weeks of intermittent pulse treatment [ Time Frame: After 48 weeks of treatment ]

Secondary Outcome Measures:
  • Impact of treatment on the health related Quality of Life in St. George's Respiratory Questionaire (SGRQ) scores [ Time Frame: At week 48 ]
  • Deterioration in lung function test (PFEV1) [ Time Frame: At week 48 ]
  • Frequency of hospitalisation [ Time Frame: At week 48 ]
  • Mortality rates [ Time Frame: At week 48 ]
  • Time of first exacerbation [ Time Frame: Through to week 48 ]
  • Frequency of acute exacerbation of chronic bronchitis [ Time Frame: At week 24 and 72 (end of follow-up) ]
  • Time to next exacerbation from last pulsed dose [ Time Frame: At week 48 ]
  • Length of exacerbations [ Time Frame: Through to week 48 ]
  • Percentage of exacerbation free time [ Time Frame: Through to week 48 ]

Enrollment: 1402
Study Start Date: October 2004
Study Completion Date: January 2007
Arms Assigned Interventions
Arm 1: Experimental Drug: Avelox (Moxifloxacin, BAY12-8039)
Avelox (Moxifloxacin, BAY12-8039), 400 mg capsules orally once daily for 5 days every 8 weeks
Arm 2: Placebo Comparator Drug: Placebo
Matching placebo capsules orally once daily for 5 days every 8 weeks.

  Eligibility

Ages Eligible for Study:   45 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 months If 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00473460

  Hide Study Locations
Locations
United States, Arizona
Tucson, Arizona, United States, 85723
United States, California
Long Beach, California, United States, 90822-5201
Los Angeles, California, United States, 90073-1003
United States, Florida
Bay Pines, Florida, United States, 33744
United States, Missouri
Kansas City, Missouri, United States, 64128-2295
United States, New York
Buffalo, New York, United States, 14215-1129
United States, Texas
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78284-5799
Dallas, Texas, United States, 75216-7167
Houston, Texas, United States, 77024
United States, Virginia
Richmond, Virginia, United States, 23249-0002
Andorra
Escaldes - Engordany, Andorra
Argentina, Buenos Aires
Florencio Varela, Buenos Aires, Argentina, 1888
Argentina, Capital Federal
Buenos Aires, Capital Federal, Argentina, C1120AAF
Buenos Aires, Capital Federal, Argentina, 1416
Buenos Aires, Capital Federal, Argentina, 1426
Brazil, mg
Juiz de Fora, mg, Brazil, 36036-110
Brazil, RS
Porto Alegre, RS, Brazil, 90610-000
Brazil, SP
Sao Paulo, SP, Brazil, 05403-900
Sao Paulo, SP, Brazil, 04023-900
Chile
Santiago, Chile
Valparaiso, Chile, 236-3058
France
ARRAS, France, 62000
NICE, France, 06000
ORTHEZ, France, 64300
STRASBOURG, France, 67000
ROSIERS D'EGLETONS, France, 19300
MONT-DE-MARSAN, France, 40000
Germany
Berlin, Germany, 10969
Berlin, Germany, 12043
Berlin, Germany, 10717
Hamburg, Germany, 20535
Germany, Bayern
Kaufbeuren, Bayern, Germany, 87600
Germany, Hessen
Gelnhausen, Hessen, Germany, 63571
Germany, Niedersachsen
Rotenburg, Niedersachsen, Germany, 27356
Hannover, Niedersachsen, Germany, 30159
Germany, Nordrhein-Westfalen
Witten, Nordrhein-Westfalen, Germany, 58452
Germany, Rheinland-Pfalz
Neuwied, Rheinland-Pfalz, Germany, 56564
Germany, Schleswig-Holstein
Bad Segeberg, Schleswig-Holstein, Germany, 23795
Greece
Athens, Greece, 11527
Greece, Patras
Rio, Patras, Greece, 265 04
Ireland
Dublin, Ireland, DUBLIN 7
Dublin, Ireland, 8
Israel
Tel Aviv, Israel, 64239
Afula, Israel, 18101
Bat Yam, Israel, 59512
Ashkelon, Israel, 78306
Italy
Pavia, Italy, 27100
Milano, Italy, 20123
Milano, Italy, 20157
Ferrara, Italy, 44100
Mexico
Chihuahua, Mexico, 31350
Mexico, Jalisco
Guadalajara, Jalisco, Mexico, 44280
Mexico, Yucatán
Mérida, Yucatán, Mexico, 97070
Mérida, Yucatán, Mexico, 97001
South Africa, Free State
Bloemfontein, Free State, South Africa, 9301
Bloemfontein, Free State, South Africa, 9300
South Africa, Gauteng
Pretoria, Gauteng, South Africa, 0040
Pretoria, Gauteng, South Africa, 0157
Johannesburg, Gauteng, South Africa, 2057
South Africa, KwaZulu Natal
Durban, KwaZulu Natal, South Africa, 4091
South Africa, Western Cape
Cape Town, Western Cape, South Africa, 7531
Cape Town, Western Cape, South Africa, 7569
Paarl, Western Cape, South Africa, 7646
Spain
Barcelona, Spain, 08036
Madrid, Spain, 28040
Valencia, Spain, 46009
Valladolid, Spain, 47010
Spain, Barcelona
Badalona, Barcelona, Spain, 08916
Spain, Málaga
Ronda, Málaga, Spain, 29400
United Kingdom, Avon
Bristol, Avon, United Kingdom, BS10 5NB
United Kingdom, Greater London
London, Greater London, United Kingdom, E2 9JX
London, Greater London, United Kingdom, SW3 6NP
London, Greater London, United Kingdom, SW17 0QT
London, Greater London, United Kingdom, E1 2AT
London, Greater London, United Kingdom, NW3 2QG
United Kingdom, West Midlands
Birmingham, West Midlands, United Kingdom, B15 2TH
United Kingdom, West Yorkshire
Leeds, West Yorkshire, United Kingdom, LS9 7TF
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer Healthcare Pharmaceuticals Inc. ( Therapeutic Area Head )
Study ID Numbers: 11229, EudraCT No: 2004-000404-40
Study First Received: May 14, 2007
Last Updated: June 29, 2009
ClinicalTrials.gov Identifier: NCT00473460     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Chronic bronchitis
Chronic obstructive pulmonary disease
Acute exacerbation of chronic bronchitis
Prevention therapy
Antibiotics
Fluoroquinolone
Moxifloxacin
AECB

Additional relevant MeSH terms:
Acute Disease
Anti-Infective Agents
Disease Attributes
Bronchial Diseases
Pharmacologic Actions
Bronchitis, Chronic
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Moxifloxacin
Therapeutic Uses
Lung Diseases
Bronchitis
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on November 27, 2009