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

Sponsored by:	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: Placebo Drug: Moxifloxacin Drug: Azithromycin SR	Phase III

MedlinePlus related topics: Antibiotics Bronchitis

Drug Information available for: Azithromycin Moxifloxacin Moxifloxacin hydrochloride

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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).

Further study details as provided by Pfizer:

Primary Outcome Measures:

Clinical Response at Test of Cure Visit [ Time Frame: Day12-19 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Bacteriologic response at Test of cure visit [ Time Frame: Day12-19 ] [ Designated as safety issue: No ]
Time to first recurrence of AECB [ Time Frame: recurrence date ] [ Designated as safety issue: No ]
Health status documented in the clinical COPD Questionnaire(CCQ) [ Time Frame: day1-7, TOC, first follow-up visit ] [ Designated as safety issue: No ]
Safety and tolerability [ Time Frame: during the whole study ] [ Designated as safety issue: Yes ]

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

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
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

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0661147
Study First Received:	November 14, 2005
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00254566
Health Authority:	Singapore: Health Sciences Authority

Keywords provided by Pfizer:

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

Study placed in the following topic categories:

Acute Disease
Bronchitis, Chronic
Lung Diseases, Obstructive
Respiratory Tract Infections
Respiratory Tract Diseases

Moxifloxacin
Azithromycin
Lung Diseases
Bronchitis
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Disease Attributes
Pathologic Processes

Bronchial Diseases
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009