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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00254566

Purpose

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

Condition	Intervention	Phase
Chronic Bronchitis	Other: Moxifloxacin Placebo Drug: Moxifloxacin Other: Azithromycin SR Placebo Drug: Azithromycin SR	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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).

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Chronic Bronchitis

Drug Information available for: Azithromycin Azithromycin dihydrate Azithromycin monohydrate Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Percentage of Clinical Cure (Success) at Test of Cure Visit(Clinical Per Protocol Population) [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of Clinical Cure (Success) at Test of Cure Visit (Full Analysis Set) [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ] [ Designated as safety issue: No ]
Percentage of Clinical Cure (Success)at Test of Cure Visit(Clinically Eligible Set) [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ] [ Designated as safety issue: No ]
Percentage of Bacteriologic Response at Test of Cure Visit [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ] [ Designated as safety issue: No ]
Time Taken for First Quartile (25%) of Subjects to Have AECB Recurrence [ Time Frame: Number of Days ] [ Designated as safety issue: No ]
Change From Baseline in Clinical COPD Questionnaire(CCQ)Total Score [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ] [ Designated as safety issue: No ]
Change From Baseline in Clinical COPD Questionnaire(CCQ)Symptoms Score [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ] [ Designated as safety issue: No ]
Change From Baseline in Clinical COPD Questionnaire(CCQ)Functional State Score [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ] [ Designated as safety issue: No ]
Change From Baseline in Clinical COPD Questionnaire(CCQ)Mental State Score [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ] [ Designated as safety issue: No ]

Enrollment:	398
Study Start Date:	February 2006
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Other: Azithromycin SR Placebo single dose, oral. Drug: Azithromycin SR single dose 2.0 g oral
Active Comparator: 2	Other: Moxifloxacin Placebo 1 capsule once daily for 5 days Drug: Moxifloxacin 1 X 400mg capsule once daily for 5 days

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254566

Show 34 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00254566 History of Changes
Other Study ID Numbers:	A0661147
Study First Received:	November 14, 2005
Results First Received:	July 22, 2009
Last Updated:	November 3, 2009
Health Authority:	Singapore: Health Sciences Authority

Keywords provided by Pfizer:

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

Additional relevant MeSH terms:

Bronchitis
Acute Disease
Bronchitis, Chronic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Azithromycin

Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 24, 2012