A Trial To Evaluate Two Antibiotics For The Treatment Of Acute Exacerbation Of Chronic Bronchitis (AECB)
NCT ID: NCT00254566
Last Updated: 2009-11-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
398 participants
INTERVENTIONAL
2006-02-28
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Azithromycin SR Placebo
single dose, oral.
Azithromycin SR
single dose 2.0 g oral
2
Moxifloxacin Placebo
1 capsule once daily for 5 days
Moxifloxacin
1 X 400mg capsule once daily for 5 days
Interventions
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Moxifloxacin Placebo
1 capsule once daily for 5 days
Moxifloxacin
1 X 400mg capsule once daily for 5 days
Azithromycin SR Placebo
single dose, oral.
Azithromycin SR
single dose 2.0 g oral
Eligibility Criteria
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Inclusion Criteria
* Production of purulent sputum as defined by Gram stained sputum specimen
* Presence of all of the following:
* Increased sputum production
* Increased dyspnea
* Increased cough
* At least two exacerbations of AECB in the past 12 months
* Documented FEV1 less than 80% of predicted
Exclusion Criteria
* Treatment with any systemic antibiotic within the twenty-one days prior to study entry or those with a chance of receiving other systemic antibiotics during study participation
50 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Guangzhou, Guangdong, China
Pfizer Investigational Site
Shijiazhuang, Hebei, China
Pfizer Investigational Site
Nanjing, Jiangsu, China
Pfizer Investigational Site
Shenyang, Liaoning, China
Pfizer Investigational Site
Xi’an, Shanxi, China
Pfizer Investigational Site
Xi’an, Shanxi, China
Pfizer Investigational Site
Hangzhou, Zhejiang, China
Pfizer Investigational Site
Beijing, , China
Pfizer Investigational Site
Beijing, , China
Pfizer Investigational Site
Chongqing, , China
Pfizer Investigational Site
Chongqing, , China
Pfizer Investigational Site
Hangzhou, , China
Pfizer Investigational Site
Shanghai, , China
Pfizer Investigational Site
Shanghai, , China
Pfizer Investigational Site
Shanghai, , China
Pfizer Investigational Site
Cheras, Kuala Lumpur, Malaysia
Pfizer Investigational Site
Lembah Pantai, Kuala Lumpur, Malaysia
Pfizer Investigational Site
Manila, , Philippines
Pfizer Investigational Site
Manila, , Philippines
Pfizer Investigational Site
Quezon City, , Philippines
Pfizer Investigational Site
Quezon City, , Philippines
Pfizer Investigational Site
Singapore, Singapore, Singapore
Pfizer Investigational Site
Singapore, , Singapore
Pfizer Investigational Site
Neihu, Taipei, Taiwan
Pfizer Investigational Site
Kuei Shan Hsiang, Taoyuan Hsien, Taiwan
Pfizer Investigational Site
Taichung, , Taiwan
Pfizer Investigational Site
Taichung, , Taiwan
Pfizer Investigational Site
Taipei, , Taiwan
Pfizer Investigational Site
Vachira Dusit, Bangkok, Thailand
Pfizer Investigational Site
Maerim, Chiangmai, Thailand
Pfizer Investigational Site
Bangkok, , Thailand
Pfizer Investigational Site
Bangkok, , Thailand
Pfizer Investigational Site
Chiang Mai, , Thailand
Pfizer Investigational Site
Khon Kaen, , Thailand
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A0661147
Identifier Type: -
Identifier Source: org_study_id
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