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

NCT ID: NCT00254566

Last Updated: 2009-11-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

398 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-08-31

Brief Summary

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

Detailed Description

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Conditions

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Chronic Bronchitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

Azithromycin SR Placebo

Intervention Type OTHER

single dose, oral.

Azithromycin SR

Intervention Type DRUG

single dose 2.0 g oral

2

Group Type ACTIVE_COMPARATOR

Moxifloxacin Placebo

Intervention Type OTHER

1 capsule once daily for 5 days

Moxifloxacin

Intervention Type DRUG

1 X 400mg capsule once daily for 5 days

Interventions

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Moxifloxacin Placebo

1 capsule once daily for 5 days

Intervention Type OTHER

Moxifloxacin

1 X 400mg capsule once daily for 5 days

Intervention Type DRUG

Azithromycin SR Placebo

single dose, oral.

Intervention Type OTHER

Azithromycin SR

single dose 2.0 g oral

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Guangzhou, Guangdong, China

Site Status

Pfizer Investigational Site

Shijiazhuang, Hebei, China

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Nanjing, Jiangsu, China

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Shenyang, Liaoning, China

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Xi’an, Shanxi, China

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Xi’an, Shanxi, China

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Hangzhou, Zhejiang, China

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Beijing, , China

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Beijing, , China

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Chongqing, , China

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Chongqing, , China

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Hangzhou, , China

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Shanghai, , China

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Shanghai, , China

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Shanghai, , China

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Cheras, Kuala Lumpur, Malaysia

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Lembah Pantai, Kuala Lumpur, Malaysia

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Manila, , Philippines

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Manila, , Philippines

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Quezon City, , Philippines

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Quezon City, , Philippines

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Singapore, Singapore, Singapore

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Singapore, , Singapore

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Neihu, Taipei, Taiwan

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Kuei Shan Hsiang, Taoyuan Hsien, Taiwan

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Taichung, , Taiwan

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Taichung, , Taiwan

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Taipei, , Taiwan

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Vachira Dusit, Bangkok, Thailand

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Maerim, Chiangmai, Thailand

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Bangkok, , Thailand

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Bangkok, , Thailand

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Chiang Mai, , Thailand

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Khon Kaen, , Thailand

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Countries

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China Malaysia Philippines Singapore Taiwan Thailand

Related Links

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Other Identifiers

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A0661147

Identifier Type: -

Identifier Source: org_study_id

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