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

Lung Diseases Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00473460
• Other study ID #: 11229
• Secondary ID: EudraCT No: 2004
• Status: Completed
• Phase: Phase 3
• First received: May 14, 2007
• Last updated: October 27, 2014
• Start date: October 2004
• Est. completion date: January 2007

Study information

• Verified date: October 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1404
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 90 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Disease
• Bronchitis
• Bronchitis, Chronic
• Lung Diseases

Intervention

Drug:
• Avelox (Moxifloxacin, BAY12-8039)
Avelox (Moxifloxacin, BAY12-8039), 400 mg capsules orally once daily for 5 days every 8 weeks
• Placebo
Matching placebo capsules orally once daily for 5 days every 8 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Andorra,  Argentina,  Brazil,  Chile,  France,  Germany,  Greece,  Ireland,  Israel,  Italy,  Mexico,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of exacerbations after 48 weeks of intermittent pulse treatment		After 48 weeks of treatment
Secondary	Impact of treatment on the health related Quality of Life in St. George's Respiratory Questionaire (SGRQ) scores		At week 48
Secondary	Deterioration in lung function test (PFEV1)		At week 48
Secondary	Frequency of hospitalisation		At week 48
Secondary	Mortality rates		At week 48
Secondary	Time of first exacerbation		Through to week 48
Secondary	Frequency of acute exacerbation of chronic bronchitis		At week 24 and 72 (end of follow-up)
Secondary	Time to next exacerbation from last pulsed dose		At week 48
Secondary	Length of exacerbations		Through to week 48
Secondary	Percentage of exacerbation free time		Through to week 48

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