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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00254566
Recruitment Status : Completed
First Posted : November 16, 2005
Results First Posted : September 2, 2009
Last Update Posted : November 11, 2009
Sponsor:
Information provided by:
Pfizer

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

Condition or disease Intervention/treatment Phase
Chronic Bronchitis Other: Moxifloxacin Placebo Drug: Moxifloxacin Other: Azithromycin SR Placebo Drug: Azithromycin SR Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 398 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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).
Study Start Date : February 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Percentage of Clinical Cure (Success) at Test of Cure Visit(Clinical Per Protocol Population) [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ]

Secondary Outcome Measures :
  1. Percentage of Clinical Cure (Success) at Test of Cure Visit (Full Analysis Set) [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ]
  2. Percentage of Clinical Cure (Success)at Test of Cure Visit(Clinically Eligible Set) [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ]
  3. Percentage of Bacteriologic Response at Test of Cure Visit [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ]
  4. Time Taken for First Quartile (25%) of Subjects to Have AECB Recurrence [ Time Frame: Number of Days ]
  5. Change From Baseline in Clinical COPD Questionnaire(CCQ)Total Score [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ]
  6. Change From Baseline in Clinical COPD Questionnaire(CCQ)Symptoms Score [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ]
  7. Change From Baseline in Clinical COPD Questionnaire(CCQ)Functional State Score [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ]
  8. Change From Baseline in Clinical COPD Questionnaire(CCQ)Mental State Score [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00254566


Locations
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China, Guangdong
Pfizer Investigational Site
Guangzhou, Guangdong, China, 510080
China, Hebei
Pfizer Investigational Site
Shijiazhuang, Hebei, China, 050000
China, Jiangsu
Pfizer Investigational Site
Nanjing, Jiangsu, China, 210002
China, Liaoning
Pfizer Investigational Site
Shenyang, Liaoning, China, 110016
China, Shanxi
Pfizer Investigational Site
Xi'an, Shanxi, China, 710032
Pfizer Investigational Site
Xi'an, Shanxi, China, 710061
China, Zhejiang
Pfizer Investigational Site
Hangzhou, Zhejiang, China, 310009
China
Pfizer Investigational Site
Beijing, China, 100034
Pfizer Investigational Site
Beijing, China, 100083
Pfizer Investigational Site
Chongqing, China, 400016
Pfizer Investigational Site
Chongqing, China, 400037
Pfizer Investigational Site
Hangzhou, China, 310003
Pfizer Investigational Site
Shanghai, China, 200025
Pfizer Investigational Site
Shanghai, China, 200040
Pfizer Investigational Site
Shanghai, China, 200080
Malaysia
Pfizer Investigational Site
Cheras, Kuala Lumpur, Malaysia, 56000
Pfizer Investigational Site
Lembah Pantai, Kuala Lumpur, Malaysia, 50603
Philippines
Pfizer Investigational Site
Manila, Philippines, 1000
Pfizer Investigational Site
Manila, Philippines, 1008
Pfizer Investigational Site
Quezon City, Philippines, 1100
Pfizer Investigational Site
Quezon City, Philippines, 1104
Singapore
Pfizer Investigational Site
Singapore, Singapore, 169608
Pfizer Investigational Site
Singapore, Singapore, 308433
Taiwan
Pfizer Investigational Site
NeiHu, Taipei, Taiwan, 114
Pfizer Investigational Site
Kuei Shan Hsiang, Taoyuan Hsien, Taiwan, 333
Pfizer Investigational Site
Taichung, Taiwan, 404
Pfizer Investigational Site
Taichung, Taiwan, 40705
Pfizer Investigational Site
Taipei, Taiwan, 100
Thailand
Pfizer Investigational Site
Vachira Dusit, Bangkok, Thailand, 10330
Pfizer Investigational Site
Maerim, Chiangmai, Thailand, 50180
Pfizer Investigational Site
Bangkok, Thailand, 10110
Pfizer Investigational Site
Bangkok, Thailand, 10700
Pfizer Investigational Site
Chiang Mai, Thailand, 50200
Pfizer Investigational Site
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00254566    
Other Study ID Numbers: A0661147
First Posted: November 16, 2005    Key Record Dates
Results First Posted: September 2, 2009
Last Update Posted: November 11, 2009
Last Verified: November 2009
Keywords provided by Pfizer:
Azithromycin SR; Moxifloxacin; Acute exacerbation of chronic bronchitis (AECB)
Additional relevant MeSH terms:
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Bronchitis
Bronchitis, Chronic
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs