Status:
COMPLETED
A Trial To Evaluate Two Antibiotics For The Treatment Of Acute Exacerbation Of Chronic Bronchitis (AECB)
Lead Sponsor:
Pfizer
Conditions:
Chronic Bronchitis
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
This trial is a research drug study to compare the effects of two antibiotics for the treatment of acute exacerbation of chronic bronchitis
Eligibility Criteria
Inclusion
- Diagnosis of chronic bronchitis (chronic cough and sputum production on most days for three consecutive months for more than two consecutive years) and clinical evidence of AECB as demonstrated by both the following symptoms:
- 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
- A chest radiograph consistent with pneumonia
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
398 Patients enrolled
Trial Details
Trial ID
NCT00254566
Start Date
February 1 2006
End Date
August 1 2008
Last Update
November 11 2009
Active Locations (34)
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1
Pfizer Investigational Site
Guangzhou, Guangdong, China, 510080
2
Pfizer Investigational Site
Shijiazhuang, Hebei, China, 050000
3
Pfizer Investigational Site
Nanjing, Jiangsu, China, 210002
4
Pfizer Investigational Site
Shenyang, Liaoning, China, 110016