Clinical trial NCT00254566: A Trial To Evaluate Two Antibiotics For The Treatment Of Acute Exacerbation Of Chronic Bronchitis (AECB)
Official title: A Phase 3B Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial To Evaluate The Efficacy and Safety Of Azithromycin SR (Microspheres Formulation) Versus Moxifloxacin For The Treatment Of Acute Exacerbation Of Chronic Bronchitis (AECB).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Bronchitis
Keywords: Azithromycin SR; Moxifloxacin; Acute exacerbation of chronic bronchitis (AECB)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-11-16
Enrollment: 398
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Percentage of Clinical Cure (Success) at Test of Cure Visit(Clinical Per Protocol Population)
timeFrame: Test of Cure (TOC) Visit (Day 12-19)
Secondary outcomes:
measure: Percentage of Clinical Cure (Success) at Test of Cure Visit (Full Analysis Set)
timeFrame: Test of Cure (TOC) Visit (Day 12-19)
measure: Percentage of Clinical Cure (Success)at Test of Cure Visit(Clinically Eligible Set)
timeFrame: Test of Cure (TOC) Visit (Day 12-19)
measure: Percentage of Bacteriologic Response at Test of Cure Visit
timeFrame: Test of Cure (TOC) Visit (Day 12-19)
measure: Time Taken for First Quartile (25%) of Subjects to Have AECB Recurrence
timeFrame: Number of Days
measure: Change From Baseline in Clinical COPD Questionnaire(CCQ)Total Score
timeFrame: Test of Cure (TOC) Visit (Day 12-19)
measure: Change From Baseline in Clinical COPD Questionnaire(CCQ)Symptoms Score
timeFrame: Test of Cure (TOC) Visit (Day 12-19)
measure: Change From Baseline in Clinical COPD Questionnaire(CCQ)Functional State Score
timeFrame: Test of Cure (TOC) Visit (Day 12-19)
measure: Change From Baseline in Clinical COPD Questionnaire(CCQ)Mental State Score
timeFrame: Test of Cure (TOC) Visit (Day 12-19)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Pfizer Investigational Site
state: Guangdong
city: Shijiazhuang
country: China
facility: Pfizer Investigational Site
state: Hebei
city: Nanjing
country: China
facility: Pfizer Investigational Site
state: Jiangsu
city: Shenyang
country: China
facility: Pfizer Investigational Site
state: Liaoning
city: Xi'an
country: China
facility: Pfizer Investigational Site
state: Shanxi
city: Xi'an
country: China
facility: Pfizer Investigational Site
state: Shanxi
city: Hangzhou
country: China
facility: Pfizer Investigational Site
state: Zhejiang
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Chongqing
country: China
facility: Pfizer Investigational Site
city: Chongqing
country: China
facility: Pfizer Investigational Site
city: Hangzhou
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Cheras
country: Malaysia
facility: Pfizer Investigational Site
state: Kuala Lumpur
city: Lembah Pantai
country: Malaysia
facility: Pfizer Investigational Site
state: Kuala Lumpur
city: Manila
country: Philippines
facility: Pfizer Investigational Site
city: Manila
country: Philippines
facility: Pfizer Investigational Site
city: Quezon City
country: Philippines
facility: Pfizer Investigational Site
city: Quezon City
country: Philippines
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: NeiHu
country: Taiwan
facility: Pfizer Investigational Site
state: Taipei
city: Kuei Shan Hsiang
country: Taiwan
facility: Pfizer Investigational Site
state: Taoyuan Hsien
city: Taichung
country: Taiwan
facility: Pfizer Investigational Site
city: Taichung
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Vachira Dusit
country: Thailand
facility: Pfizer Investigational Site
state: Bangkok
city: Maerim
country: Thailand
facility: Pfizer Investigational Site
state: Chiangmai
city: Bangkok
country: Thailand
facility: Pfizer Investigational Site
city: Bangkok
country: Thailand
facility: Pfizer Investigational Site
city: Chiang Mai
country: Thailand
facility: Pfizer Investigational Site
city: Khon Kaen
country: Thailand
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: