Clinical trial NCT00473460: Intermittent Moxifloxacin Therapy For The Prevention Of Acute Exacerbations In Patients With Chronic Bronchitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Diseases
Bronchitis, Chronic
Keywords: Chronic bronchitis
Chronic obstructive pulmonary disease
Acute exacerbation of chronic bronchitis
Prevention therapy
Antibiotics
Fluoroquinolone
Moxifloxacin
AECB
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-05-15
Enrollment: 1404
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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)

Primary outcomes:
measure: Number of exacerbations after 48 weeks of intermittent pulse treatment
timeFrame: After 48 weeks of treatment
Secondary outcomes:
measure: Impact of treatment on the health related Quality of Life in St. George's Respiratory Questionaire (SGRQ) scores
timeFrame: At week 48
measure: Deterioration in lung function test (PFEV1)
timeFrame: At week 48
measure: Frequency of hospitalisation
timeFrame: At week 48
measure: Mortality rates
timeFrame: At week 48
measure: Time of first exacerbation
timeFrame: Through to week 48
measure: Frequency of acute exacerbation of chronic bronchitis
timeFrame: At week 24 and 72 (end of follow-up)
measure: Time to next exacerbation from last pulsed dose
timeFrame: At week 48
measure: Length of exacerbations
timeFrame: Through to week 48
measure: Percentage of exacerbation free time
timeFrame: Through to week 48
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Bay Pines
country: United States
state: Florida
city: Kansas City
country: United States
state: Missouri
city: Buffalo
country: United States
state: New York
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Escaldes - Engordany
country: Andorra
city: Florencio Varela
country: Argentina
state: Buenos Aires
city: Buenos Aires
country: Argentina
state: Capital Federal
city: Buenos Aires
country: Argentina
state: Capital Federal
city: Buenos Aires
country: Argentina
state: Capital Federal
city: Juiz de Fora
country: Brazil
state: MG
city: Porto Alegre
country: Brazil
state: RS
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Santiago
country: Chile
city: Valparaiso
country: Chile
city: Arras
country: France
city: Mont-de-marsan
country: France
city: Nice
country: France
city: Orthez
country: France
city: Rosiers D'egletons
country: France
city: Strasbourg
country: France
city: Kaufbeuren
country: Germany
state: Bayern
city: Gelnhausen
country: Germany
state: Hessen
city: Hannover
country: Germany
state: Niedersachsen
city: Rotenburg
country: Germany
state: Niedersachsen
city: Witten
country: Germany
state: Nordrhein-Westfalen
city: Neuwied
country: Germany
state: Rheinland-Pfalz
city: Bad Segeberg
country: Germany
state: Schleswig-Holstein
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Rio
country: Greece
state: Patras
city: Athens
country: Greece
city: Dublin
country: Ireland
city: Dublin
country: Ireland
city: Afula
country: Israel
city: Ashkelon
country: Israel
city: Bat Yam
country: Israel
city: Tel Aviv
country: Israel
city: Ferrara
country: Italy
city: Milano
country: Italy
city: Milano
country: Italy
city: Pavia
country: Italy
city: Guadalajara
country: Mexico
state: Jalisco
city: Mérida
country: Mexico
state: Yucatán
city: Mérida
country: Mexico
state: Yucatán
city: Chihuahua
country: Mexico
city: Bloemfontein
country: South Africa
state: Free State
city: Bloemfontein
country: South Africa
state: Free State
city: Johannesburg
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Durban
country: South Africa
state: KwaZulu Natal
city: Cape Town
country: South Africa
state: Western Cape
city: Cape Town
country: South Africa
state: Western Cape
city: Paarl
country: South Africa
state: Western Cape
city: Badalona
country: Spain
state: Barcelona
city: Ronda
country: Spain
state: Málaga
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Valencia
country: Spain
city: Valladolid
country: Spain
city: Bristol
country: United Kingdom
state: Avon
city: London
country: United Kingdom
state: Greater London
city: London
country: United Kingdom
state: Greater London
city: London
country: United Kingdom
state: Greater London
city: London
country: United Kingdom
state: Greater London
city: London
country: United Kingdom
state: Greater London
city: Birmingham
country: United Kingdom
state: West Midlands
city: Leeds
country: United Kingdom
state: West Yorkshire
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.