A Trial To Evaluate Two Antibiotics For The Treatment Of Acute Exacerbation Of Chronic Bronchitis (AECB)

Condition(s) targeted: Chronic Bronchitis

Intervention: Azithromycin SR (Drug); Placebo (Other); Moxifloxacin (Drug); Placebo (Other)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

This trial is a research drug study to compare the effects of two antibiotics for the treatment of acute exacerbation of chronic bronchitis

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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Clinical Response at Test of Cure Visit

Secondary outcome:

Bacteriologic response at Test of cure visit

Time to first recurrence of AECB

Health status documented in the clinical COPD Qestionnaire(CCQ)

Safety and tolerability

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

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:

1. Production of purulent sputum as defined by Gram stained sputum specimen

2. Presence of all of the following:

i. Increased sputum production ii. Increased dyspnea iii. Increased cough

- At least two exacerbations of AECB in the past 12 months

- 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

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Shanghai 200040, China; Active, not recruiting

Pfizer Investigational Site, Shanghai 200080, China; Completed

Pfizer Investigational Site, Shanghai 200025, China; Completed

Pfizer Investigational Site, Beijing 100083, China; Completed

Pfizer Investigational Site, Hangzhou 310003, China; Recruiting

Pfizer Investigational Site, Chongqing 400016, China; Recruiting

Pfizer Investigational Site, Chongqing 400037, China; Recruiting

Pfizer Investigational Site, Beijing 100034, China; Completed

Pfizer Investigational Site, Manila 1000, Philippines; Recruiting

Pfizer Investigational Site, Quezon City 1100, Philippines; Recruiting

Pfizer Investigational Site, Manila 1008, Philippines; Recruiting

Pfizer Investigational Site, Quezon City 1104, Philippines; Recruiting

Pfizer Investigational Site, Singapore 169608, Singapore; Completed

Pfizer Investigational Site, Singapore 308433, Singapore; Active, not recruiting

Pfizer Investigational Site, Taipei 100, Taiwan; Recruiting

Pfizer Investigational Site, Taichung 40705, Taiwan; Recruiting

Pfizer Investigational Site, Taichung 404, Taiwan; Recruiting

Pfizer Investigational Site, Bangkok 10700, Thailand; Completed

Pfizer Investigational Site, Chiang Mai 50200, Thailand; Recruiting

Pfizer Investigational Site, Khon Kaen 40002, Thailand; Recruiting

Pfizer Investigational Site, Bangkok 10110, Thailand; Recruiting

Pfizer Investigational Site, Vachira Dusit, BANGKOK 10330, Thailand; Completed

Pfizer Investigational Site, Maerim, Chiangmai 50180, Thailand; Recruiting

Pfizer Investigational Site, Guangzhou, GUANGDONG 510080, China; Recruiting

Pfizer Investigational Site, Shijiazhuang, Hebei Province 050000, China; Recruiting

Pfizer Investigational Site, Nanjing, Jiangsu 210002, China; Completed

Pfizer Investigational Site, Cheras, Kuala Lumpur 56000, Malaysia; Completed

Pfizer Investigational Site, Lembah Pantai, Kuala Lumpur 50603, Malaysia; Completed

Pfizer Investigational Site, Shenyang, Liaoning 110016, China; Active, not recruiting

Pfizer Investigational Site, Xi'an, Shanxi Province 710061, China; Completed

Pfizer Investigational Site, Xi'an, Shanxi Province 710032, China; Recruiting

Pfizer Investigational Site, NeiHu, Taipei 114, Taiwan; Recruiting

Pfizer Investigational Site, Kuei Shan Hsiang, Taoyuan Hsien 333, Taiwan; Recruiting

Pfizer Investigational Site, Hangzhou, Zhejiang 310009, China; Recruiting

To obtain contact information for a study center near you, click here.

Starting date: February 2006
Ending date: July 2008
Last updated: June 30, 2008