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

NCT00254566 | Completed Phase 3 Results

• 1 other identifier: A0661147
• Study Type: interventional
• Target: 398
• Locations: 6 countries
• Sites: 34

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

Conditions

Chronic Bronchitis

Keywords

Azithromycin SR; Moxifloxacin; Acute exacerbation of chronic bronchitis (AECB)

Outcome Measures

Primary Outcomes (1)

• Percentage of Clinical Cure (Success) at Test of Cure Visit(Clinical Per Protocol Population)

  Cure=Signs\&symptoms(S\&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S\&S of acute infection persisted/worsened,new clinical S\&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub

  Test of Cure (TOC) Visit (Day 12-19)

Secondary Outcomes (8)

• Percentage of Clinical Cure (Success) at Test of Cure Visit (Full Analysis Set)

  Test of Cure (TOC) Visit (Day 12-19)

• Percentage of Clinical Cure (Success)at Test of Cure Visit(Clinically Eligible Set)

  Test of Cure (TOC) Visit (Day 12-19)

• Percentage of Bacteriologic Response at Test of Cure Visit

  Test of Cure (TOC) Visit (Day 12-19)

• Time Taken for First Quartile (25%) of Subjects to Have AECB Recurrence

  Number of Days

• Change From Baseline in Clinical COPD Questionnaire(CCQ)Total Score

  Test of Cure (TOC) Visit (Day 12-19)

Study Arms (2)

1

EXPERIMENTAL

Other: Azithromycin SR Placebo; Drug: Azithromycin SR

2

ACTIVE COMPARATOR

Other: Moxifloxacin Placebo; Drug: Moxifloxacin

Interventions

Moxifloxacin Placebo OTHER

1 capsule once daily for 5 days

2

Moxifloxacin DRUG

1 X 400mg capsule once daily for 5 days

2

Azithromycin SR Placebo OTHER

single dose, oral.

1

Azithromycin SR DRUG

single dose 2.0 g oral

1

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (34)

Pfizer Investigational Site

Guangzhou, Guangdong, 510080, China

Location

Pfizer Investigational Site

Shijiazhuang, Hebei, 050000, China

Location

Pfizer Investigational Site

Nanjing, Jiangsu, 210002, China

Location

Pfizer Investigational Site

Shenyang, Liaoning, 110016, China

Location

Pfizer Investigational Site

Xi’an, Shanxi, 710032, China

Location

Pfizer Investigational Site

Xi’an, Shanxi, 710061, China

Location

Pfizer Investigational Site

Hangzhou, Zhejiang, 310009, China

Location

Pfizer Investigational Site

Beijing, 100034, China

Location

Pfizer Investigational Site

Beijing, 100083, China

Location

Pfizer Investigational Site

Chongqing, 400016, China

Location

Pfizer Investigational Site

Chongqing, 400037, China

Location

Pfizer Investigational Site

Hangzhou, 310003, China

Location

Pfizer Investigational Site

Shanghai, 200025, China

Location

Pfizer Investigational Site

Shanghai, 200040, China

Location

Pfizer Investigational Site

Shanghai, 200080, China

Location

Pfizer Investigational Site

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Pfizer Investigational Site

Lembah Pantai, Kuala Lumpur, 50603, Malaysia

Location

Pfizer Investigational Site

Manila, 1000, Philippines

Location

Pfizer Investigational Site

Manila, 1008, Philippines

Location

Pfizer Investigational Site

Quezon City, 1100, Philippines

Location

Pfizer Investigational Site

Quezon City, 1104, Philippines

Location

Pfizer Investigational Site

Singapore, Singapore, 169608, Singapore

Location

Pfizer Investigational Site

Singapore, 308433, Singapore

Location

Pfizer Investigational Site

Neihu, Taipei, 114, Taiwan

Location

Pfizer Investigational Site

Kuei Shan Hsiang, Taoyuan Hsien, 333, Taiwan

Location

Pfizer Investigational Site

Taichung, 404, Taiwan

Location

Pfizer Investigational Site

Taichung, 40705, Taiwan

Location

Pfizer Investigational Site

Taipei, 100, Taiwan

Location

Pfizer Investigational Site

Vachira Dusit, Bangkok, 10330, Thailand

Location

Pfizer Investigational Site

Maerim, Chiangmai, 50180, Thailand

Location

Pfizer Investigational Site

Bangkok, 10110, Thailand

Location

Pfizer Investigational Site

Bangkok, 10700, Thailand

Location

Pfizer Investigational Site

Chiang Mai, 50200, Thailand

Location

Pfizer Investigational Site

Khon Kaen, 40002, Thailand

Location

Related Links

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

MeSH Terms

Conditions

Bronchitis, Chronic

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 14, 2005
• First Posted: November 16, 2005
• Study Start: February 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: November 11, 2009
• Results First Posted: September 2, 2009

Record last verified: 2009-11

Locations

SG (2); MY (2); TH (6); PH (4); CN (15); TW (5)