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A Trial To Evaluate Two Antibiotics For The Treatment Of Acute Exacerbation Of Chronic Bronchitis - Article


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Indomethacin SR

Indocin SR 




Clinical Trial: A Trial To Evaluate Two Antibiotics For The Treatment Of Acute Exacerbation Of Chronic Bronchitis

This study is not yet open for patient recruitment.
Verified by Pfizer December 2005

Sponsors and Collaborators: Pfizer
Pfizer Global Pharmaceuticals, NY
Pfizer Global Pharmaceuticals, Asia Regional
Pfizer Global Pharmaceuticals, China
Pfizer Global Pharmaceuticals, Singapore
Pfizer Global Pharmaceuticals, Taiwan, ROC
Pfizer Global Pharmaceuticals, Philippines
Pfizer Global Pharmaceuticals, Thailand
Pfizer Global Pharmaceutials, Malaysia
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
Bronchitis, Chronic
 Drug: Azithromycin SR
 Drug: Moxifloxacin
Phase III

MedlinePlus related topics:  Bronchitis

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, 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 Outcomes: Clinical Response at Test of Cure Visit
Secondary Outcomes: Bacteriologic response at Test of cure visit Time to first recurrence of AECB Health status Safety and tolerability
Expected Total Enrollment:  416

Study start: January 2006

Eligibility

Ages Eligible for Study:  50 Years and above,  Genders Eligible for Study:  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

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00254566


Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

More Information

Study ID Numbers:  A0661147
Last Updated:  January 3, 2006
Record first received:  November 14, 2005
ClinicalTrials.gov Identifier:  NCT00254566
Health Authority: Singapore: Health Sciences Authority
ClinicalTrials.gov processed this record on 2006-01-10

Resources



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Page Updated: June 1, 2005
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