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

October 27, 2014 updated by: Bayer

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1404

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Andorra
      • Escaldes - Engordany, Andorra
  • Argentina
    • Buenos Aires
      • Florencio Varela, Buenos Aires, Argentina, 1888
    • 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
    • RS
      • Porto Alegre, RS, Brazil, 90610-000
    • SP
      • Sao Paulo, SP, Brazil, 04023-900
      • Sao Paulo, SP, Brazil, 05403-900
  • Chile
      • Santiago, Chile
      • Valparaiso, Chile, 236-3058
  • France
      • Arras, France, 62000
      • Mont-de-marsan, France, 40000
      • Nice, France, 06000
      • Orthez, France, 64300
      • Rosiers D'egletons, France, 19300
      • Strasbourg, France, 67000
  • Germany
      • Berlin, Germany, 10969
      • Berlin, Germany, 10717
      • Berlin, Germany, 12043
      • Hamburg, Germany, 20535
    • Bayern
      • Kaufbeuren, Bayern, Germany, 87600
    • Hessen
      • Gelnhausen, Hessen, Germany, 63571
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30159
      • Rotenburg, Niedersachsen, Germany, 27356
    • Nordrhein-Westfalen
      • Witten, Nordrhein-Westfalen, Germany, 58452
    • Rheinland-Pfalz
      • Neuwied, Rheinland-Pfalz, Germany, 56564
    • Schleswig-Holstein
      • Bad Segeberg, Schleswig-Holstein, Germany, 23795
  • Greece
      • Athens, Greece, 11527
    • Patras
      • Rio, Patras, Greece, 265 04
  • Ireland
      • Dublin, Ireland, DUBLIN 7
      • Dublin, Ireland, 8
  • Israel
      • Afula, Israel, 18101
      • Ashkelon, Israel, 78306
      • Bat Yam, Israel, 59512
      • Tel Aviv, Israel, 64239
  • Italy
      • Ferrara, Italy, 44100
      • Milano, Italy, 20157
      • Milano, Italy, 20123
      • Pavia, Italy, 27100
  • Mexico
      • Chihuahua, Mexico, 31350
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
    • Yucatán
      • Mérida, Yucatán, Mexico, 97001
      • Mérida, Yucatán, Mexico, 97070
  • South Africa
    • Free State
      • Bloemfontein, Free State, South Africa, 9300
      • Bloemfontein, Free State, South Africa, 9301
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2057
      • Pretoria, Gauteng, South Africa, 0040
      • Pretoria, Gauteng, South Africa, 0157
    • KwaZulu Natal
      • Durban, KwaZulu Natal, South Africa, 4091
    • 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
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
    • Málaga
      • Ronda, Málaga, Spain, 29400
  • United Kingdom
    • Avon
      • Bristol, Avon, United Kingdom, BS10 5NB
    • Greater London
      • London, Greater London, United Kingdom, NW3 2QG
      • London, Greater London, United Kingdom, SW17 0QT
      • London, Greater London, United Kingdom, E1 2AT
      • London, Greater London, United Kingdom, E2 9JX
      • London, Greater London, United Kingdom, SW3 6NP
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TH
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS9 7TF
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85723
    • California
      • Long Beach, California, United States, 90822-5201
      • Los Angeles, California, United States, 90073-1003
    • Florida
      • Bay Pines, Florida, United States, 33744
    • Missouri
      • Kansas City, Missouri, United States, 64128-2295
    • New York
      • Buffalo, New York, United States, 14215-1129
    • Texas
      • Dallas, Texas, United States, 75216-7167
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77024
      • San Antonio, Texas, United States, 78284-5799
    • Virginia
      • Richmond, Virginia, United States, 23249-0002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of exacerbations after 48 weeks of intermittent pulse treatment
Time Frame: After 48 weeks of treatment
After 48 weeks of treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

May 14, 2007

First Submitted That Met QC Criteria

May 14, 2007

First Posted (Estimate)

May 15, 2007

Study Record Updates

Last Update Posted (Estimate)

October 28, 2014

Last Update Submitted That Met QC Criteria

October 27, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11229
  • EudraCT No: 2004-000404-40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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