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

NCT ID: NCT00473460

Last Updated: 2014-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1404 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2007-01-31

Brief 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.

Conditions

Lung Diseases; Bronchitis, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Avelox (Moxifloxacin, BAY12-8039)

Intervention Type: DRUG

Avelox (Moxifloxacin, BAY12-8039), 400 mg capsules orally once daily for 5 days every 8 weeks

Arm 2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo capsules orally once daily for 5 days every 8 weeks.

Interventions

Avelox (Moxifloxacin, BAY12-8039)

Avelox (Moxifloxacin, BAY12-8039), 400 mg capsules orally once daily for 5 days every 8 weeks

Intervention Type: DRUG

Placebo

Matching placebo capsules orally once daily for 5 days every 8 weeks.

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Tucson, Arizona, United States

Long Beach, California, United States

Los Angeles, California, United States

Bay Pines, Florida, United States

Kansas City, Missouri, United States

Buffalo, New York, United States

Dallas, Texas, United States

Houston, Texas, United States

Houston, Texas, United States

San Antonio, Texas, United States

Richmond, Virginia, United States

Les Escaldes, , Andorra

San Juan Bautista, Buenos Aires, Argentina

Buenos Aires, Buenos Aires F.D., Argentina

Buenos Aires, Buenos Aires F.D., Argentina

Buenos Aires, Buenos Aires F.D., Argentina

Juiz de Fora, Minas Gerais, Brazil

Porto Alegre, Rio Grande do Sul, Brazil

São Paulo, São Paulo, Brazil

São Paulo, São Paulo, Brazil

Santiago, , Chile

Valparaíso, , Chile

Arras, , France

Mont-de-Marsan, , France

Nice, , France

Orthez, , France

Rosiers-d'Égletons, , France

Strasbourg, , France

Kaufbeuren, Bavaria, Germany

Hamburg, City state of Hamburg, Germany

Gelnhausen, Hesse, Germany

Hanover, Lower Saxony, Germany

Rotenburg (Wümme), Lower Saxony, Germany

Witten, North Rhine-Westphalia, Germany

Neuwied, Rhineland-Palatinate, Germany

Bad Segeberg, Schleswig-Holstein, Germany

Berlin, State of Berlin, Germany

Berlin, State of Berlin, Germany

Berlin, State of Berlin, Germany

Rio, Patras, Greece

Athens, , Greece

Dublin, Dublin, Ireland

Dublin, , Ireland

Afula, Israel, Israel

Ashkelon, Israel, Israel

Bat Yam, Israel, Israel

Tel Aviv, Israel, Israel

Ferrara, , Italy

Milan, , Italy

Milan, , Italy

Pavia, , Italy

Chihuahua City, Chihuahua, Mexico

Guadalajara, Jalisco, Mexico

Mérida, Yucatán, Mexico

Mérida, Yucatán, Mexico

Bloemfontein, Free State, South Africa

Bloemfontein, Free State, South Africa

Johannesburg, Gauteng, South Africa

Pretoria, Gauteng, South Africa

Pretoria, Gauteng, South Africa

Durban, KwaZulu-Natal, South Africa

Cape Town, Western Cape, South Africa

Cape Town, Western Cape, South Africa

Paarl, Western Cape, South Africa

Badalona, Barcelona, Spain

Barcelona, Barcelona, Spain

Madrid, Madrid, Spain

Ronda, Málaga, Spain

Valencia, Valencia, Spain

Valladolid, Valladolid, Spain

Bristol, Avon, United Kingdom

London, Greater London, United Kingdom

London, Greater London, United Kingdom

London, Greater London, United Kingdom

London, Greater London, United Kingdom

London, Greater London, United Kingdom

Birmingham, West Midlands, United Kingdom

Leeds, West Yorkshire, United Kingdom

Countries

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

References

Sethi S, Jones PW, Theron MS, Miravitlles M, Rubinstein E, Wedzicha JA, Wilson R; PULSE Study group. Pulsed moxifloxacin for the prevention of exacerbations of chronic obstructive pulmonary disease: a randomized controlled trial. Respir Res. 2010 Jan 28;11(1):10. doi: 10.1186/1465-9921-11-10.

Reference Type: DERIVED

PMID: 20109213 (View on PubMed)

Related Links

http://www.clinicaltrialsregister.eu

Click here and search for information on EMA

Other Identifiers

EudraCT No: 2004-000404-40

Identifier Type: -

Identifier Source: secondary_id

11229

Identifier Type: -

Identifier Source: org_study_id