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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00473460
• Date of registration: 14/05/2007
• Prospective Registration: No
• Primary sponsor: Bayer
• Public title: Intermittent Moxifloxacin Therapy For The Prevention Of Acute Exacerbations In Patients With Chronic Bronchitis
• Scientific 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.
• Date of first enrolment: October 2004
• Target sample size: 1404
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00473460
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

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)



Age minimum: 45 Years
Age maximum: 90 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Lung Diseases

Bronchitis, Chronic

Intervention(s)

Drug: Placebo

Drug: Avelox (Moxifloxacin, BAY12-8039)

Primary Outcome(s)

Number of exacerbations after 48 weeks of intermittent pulse treatment [Time Frame: After 48 weeks of treatment]

Secondary Outcome(s)

Deterioration in lung function test (PFEV1) [Time Frame: At week 48]

Length of exacerbations [Time Frame: Through to week 48]

Mortality rates [Time Frame: At week 48]

Time to next exacerbation from last pulsed dose [Time Frame: At week 48]

Impact of treatment on the health related Quality of Life in St. George's Respiratory Questionaire (SGRQ) scores [Time Frame: At week 48]

Frequency of hospitalisation [Time Frame: At week 48]

Percentage of exacerbation free time [Time Frame: Through to 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)]

Secondary ID(s)

11229

EudraCT No: 2004-000404-40

Source(s) of Monetary Support

Please refer to primary and secondary sponsors