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

Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Disease; Bronchitis, Chronic

Intervention: Avelox (Moxifloxacin, BAY12-8039) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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.

Clinical Details

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.

Study design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Number of exacerbations after 48 weeks of intermittent pulse treatment

Secondary outcome:

Impact of treatment on the health related Quality of Life in St. George's Respiratory Questionaire (SGRQ) scores

Deterioration in lung function test (PFEV1)

Frequency of hospitalisation

Mortality rates

Time of first exacerbation

Frequency of acute exacerbation of chronic bronchitis

Time to next exacerbation from last pulsed dose

Length of exacerbations

Percentage of exacerbation free time

Eligibility

Minimum age: 45 Years. Maximum age: 90 Years. Gender(s): Both.

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 months If 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)

Locations and Contacts

Escaldes - Engordany, Andorra

Santiago, Chile

Valparaiso, Chile

MONT-DE-MARSAN 40000, France

NICE 06000, France

ORTHEZ 64300, France

STRASBOURG 67000, France

ROSIERS D'EGLETONS 19300, France

ARRAS 62000, France

Athens 11527, Greece

Dublin 8, Ireland

Tel Aviv 64239, Israel

Afula 18101, Israel

Bat Yam 59512, Israel

Ashkelon 78306, Israel

Pavia 27100, Italy

Milano 20123, Italy

Milano 20157, Italy

Ferrara 44100, Italy

Chihuahua 31350, Mexico

Barcelona 08036, Spain

Madrid 28040, Spain

Valencia 46009, Spain

Tucson, Arizona 85723, United States

Bristol, Avon BS10 5NB, United Kingdom

Badalona, Barcelona 08916, Spain

Kaufbeuren, Bayern / 280 87600, Germany

Berlin, Berlin / 285 10969, Germany

Berlin, Berlin / 285 12043, Germany

Berlin, Berlin / 285 10717, Germany

Florencio Varela, Buenos Aires 1888, Argentina

Long Beach, California 90822-5201, United States

Los Angeles, California 90073-1003, United States

Buenos Aires, Capital Federal C1120AAF, Argentina

Buenos Aires, Capital Federal 1416, Argentina

Buenos Aires, Capital Federal 1426, Argentina

Valladolid, Castilla y León 47010, Spain

Bay Pines, Florida 33744, United States

Bloemfontein, Free State 9301, South Africa

Bloemfontein, Free State 9300, South Africa

Pretoria, Gauteng 0040, South Africa

Pretoria, Gauteng 0157, South Africa

Johannesburg, Gauteng 2057, South Africa

London, Greater London SW17 0QT, United Kingdom

London, Greater London E1 2AT, United Kingdom

London, Greater London NW3 2QG, United Kingdom

Hamburg, Hamburg / 287 20535, Germany

Gelnhausen, Hessen / 307 63571, Germany

Guadalajara, Jalisco 44280, Mexico

Kansas City, Missouri 64128-2295, United States

Ronda, Málaga 29400, Spain

Buffalo, New York 14215-1129, United States

Hannover, Niedersachsen / 291 30159, Germany

Witten, Nordrhein-Westfalen / 361 58452, Germany

Rio, Patras 265 00, Greece

Porto Alegre, RS 90610-000, Brazil

Neuwied, Rheinland-Pfalz / 381 56564, Germany

Sao Paulo, SP 05403-900, Brazil

Sao Paulo, SP 04023-900, Brazil

Bad Segeberg, Schleswig-Holstein / 306 23795, Germany

Houston, Texas 77030-4298, United States

San Antonio, Texas 78284-5799, United States

Dallas, Texas 75216-7167, United States

Richmond, Virginia 23249-0002, United States

Birmingham, West Midlands B15 2TH, United Kingdom

Leeds, West Yorkshire LS9 7TF, United Kingdom

Cape Town, Western Cape 7531, South Africa

Cape Town, Western Cape 7569, South Africa

Paarl, Western Cape 7646, South Africa

Mérida, Yucatán 97070, Mexico

Mérida, Yucatán 97001, Mexico

Juiz de Fora, mg 36036-110, Brazil

Additional Information

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Starting date: October 2004
Ending date: January 2007
Last updated: April 29, 2008

Page last updated: June 20, 2008

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