Intermittent Moxifloxacin Therapy For The Prevention Of Acute Exacerbations In Patients With Chronic Bronchitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00473460
First received: May 14, 2007
Last updated: October 18, 2013
Last verified: October 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Avelox (Moxifloxacin, BAY12-8039)
Avelox (Moxifloxacin, BAY12-8039), 400 mg capsules orally once daily for 5 days every 8 weeks
Placebo Comparator: Arm 2 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 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00473460

  Show 78 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00473460     History of Changes
Other Study ID Numbers: 11229, EudraCT No: 2004-000404-40
Study First Received: May 14, 2007
Last Updated: October 18, 2013
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:
Bronchitis
Bronchitis, Chronic
Pulmonary Disease, Chronic Obstructive
Acute Disease
Lung Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014