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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Chronic Bronchitis

Treatments: Other: Azithromycin SR Placebo; Drug: Moxifloxacin; Drug: Azithromycin SR; Other: Moxifloxacin Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00254566

A0661147

Details and patient eligibility

About

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

Enrollment: 398 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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398 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Azithromycin SR

Other: Azithromycin SR Placebo

2

Active Comparator group

Treatment:

Other: Moxifloxacin Placebo

Drug: Moxifloxacin