Intermittent Moxifloxacin Therapy For The Prevention Of Acute Exacerbations In Patients With Chronic Bronchitis
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.
2 other identifiers
interventional
1,404
15 countries
78
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2004
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 14, 2007
CompletedFirst Posted
Study publicly available on registry
May 15, 2007
CompletedOctober 28, 2014
October 1, 2014
2.3 years
May 14, 2007
October 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of exacerbations after 48 weeks of intermittent pulse treatment
After 48 weeks of treatment
Secondary Outcomes (9)
Impact of treatment on the health related Quality of Life in St. George's Respiratory Questionaire (SGRQ) scores
At week 48
Deterioration in lung function test (PFEV1)
At week 48
Frequency of hospitalisation
At week 48
Mortality rates
At week 48
Time of first exacerbation
Through to week 48
- +4 more secondary outcomes
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
PLACEBO COMPARATORInterventions
Avelox (Moxifloxacin, BAY12-8039), 400 mg capsules orally once daily for 5 days every 8 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (78)
Unknown Facility
Tucson, Arizona, 85723, United States
Unknown Facility
Long Beach, California, 90822-5201, United States
Unknown Facility
Los Angeles, California, 90073-1003, United States
Unknown Facility
Bay Pines, Florida, 33744, United States
Unknown Facility
Kansas City, Missouri, 64128-2295, United States
Unknown Facility
Buffalo, New York, 14215-1129, United States
Unknown Facility
Dallas, Texas, 75216-7167, United States
Unknown Facility
Houston, Texas, 77024, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
San Antonio, Texas, 78284-5799, United States
Unknown Facility
Richmond, Virginia, 23249-0002, United States
Unknown Facility
Les Escaldes, Andorra
Unknown Facility
San Juan Bautista, Buenos Aires, 1888, Argentina
Unknown Facility
Buenos Aires, Buenos Aires F.D., 1416, Argentina
Unknown Facility
Buenos Aires, Buenos Aires F.D., 1426, Argentina
Unknown Facility
Buenos Aires, Buenos Aires F.D., C1120AAF, Argentina
Unknown Facility
Juiz de Fora, Minas Gerais, 36036-110, Brazil
Unknown Facility
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Unknown Facility
São Paulo, São Paulo, 04023-900, Brazil
Unknown Facility
São Paulo, São Paulo, 05403-900, Brazil
Unknown Facility
Santiago, Chile
Unknown Facility
Valparaíso, 236-3058, Chile
Unknown Facility
Arras, 62000, France
Unknown Facility
Mont-de-Marsan, 40000, France
Unknown Facility
Nice, 06000, France
Unknown Facility
Orthez, 64300, France
Unknown Facility
Rosiers-d'Égletons, 19300, France
Unknown Facility
Strasbourg, 67000, France
Unknown Facility
Kaufbeuren, Bavaria, 87600, Germany
Unknown Facility
Hamburg, Hamburg, 20535, Germany
Unknown Facility
Gelnhausen, Hesse, 63571, Germany
Unknown Facility
Hanover, Lower Saxony, 30159, Germany
Unknown Facility
Rotenburg (Wümme), Lower Saxony, 27356, Germany
Unknown Facility
Witten, North Rhine-Westphalia, 58452, Germany
Unknown Facility
Neuwied, Rhineland-Palatinate, 56564, Germany
Unknown Facility
Bad Segeberg, Schleswig-Holstein, 23795, Germany
Unknown Facility
Berlin, State of Berlin, 10717, Germany
Unknown Facility
Berlin, State of Berlin, 10969, Germany
Unknown Facility
Berlin, State of Berlin, 12043, Germany
Unknown Facility
Rio, Patras, 265 04, Greece
Unknown Facility
Athens, 11527, Greece
Unknown Facility
Dublin, Dublin, 8, Ireland
Unknown Facility
Dublin, DUBLIN 7, Ireland
Unknown Facility
Afula, Israel, 18101, Israel
Unknown Facility
Ashkelon, Israel, 78306, Israel
Unknown Facility
Bat Yam, Israel, 59512, Israel
Unknown Facility
Tel Aviv, Israel, 64239, Israel
Unknown Facility
Ferrara, 44100, Italy
Unknown Facility
Milan, 20123, Italy
Unknown Facility
Milan, 20157, Italy
Unknown Facility
Pavia, 27100, Italy
Unknown Facility
Chihuahua City, Chihuahua, 31350, Mexico
Unknown Facility
Guadalajara, Jalisco, 44280, Mexico
Unknown Facility
Mérida, Yucatán, 97001, Mexico
Unknown Facility
Mérida, Yucatán, 97070, Mexico
Unknown Facility
Bloemfontein, Free State, 9300, South Africa
Unknown Facility
Bloemfontein, Free State, 9301, South Africa
Unknown Facility
Johannesburg, Gauteng, 2057, South Africa
Unknown Facility
Pretoria, Gauteng, 0040, South Africa
Unknown Facility
Pretoria, Gauteng, 0157, South Africa
Unknown Facility
Durban, KwaZulu-Natal, 4091, South Africa
Unknown Facility
Cape Town, Western Cape, 7531, South Africa
Unknown Facility
Cape Town, Western Cape, 7569, South Africa
Unknown Facility
Paarl, Western Cape, 7646, South Africa
Unknown Facility
Badalona, Barcelona, 08916, Spain
Unknown Facility
Barcelona, Barcelona, 08036, Spain
Unknown Facility
Madrid, Madrid, 28040, Spain
Unknown Facility
Ronda, Málaga, 29400, Spain
Unknown Facility
Valencia, Valencia, 46009, Spain
Unknown Facility
Valladolid, Valladolid, 47010, Spain
Unknown Facility
Bristol, Avon, BS10 5NB, United Kingdom
Unknown Facility
London, Greater London, E1 2AT, United Kingdom
Unknown Facility
London, Greater London, E2 9JX, United Kingdom
Unknown Facility
London, Greater London, NW3 2QG, United Kingdom
Unknown Facility
London, Greater London, SW17 0QT, United Kingdom
Unknown Facility
London, Greater London, SW3 6NP, United Kingdom
Unknown Facility
Birmingham, West Midlands, B15 2TH, United Kingdom
Unknown Facility
Leeds, West Yorkshire, LS9 7TF, United Kingdom
Related Publications (1)
Sethi S, Jones PW, Theron MS, Miravitlles M, Rubinstein E, Wedzicha JA, Wilson R; PULSE Study group. Pulsed moxifloxacin for the prevention of exacerbations of chronic obstructive pulmonary disease: a randomized controlled trial. Respir Res. 2010 Jan 28;11(1):10. doi: 10.1186/1465-9921-11-10.
PMID: 20109213DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2007
First Posted
May 15, 2007
Study Start
October 1, 2004
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
October 28, 2014
Record last verified: 2014-10