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

This study has been completed.

Study NCT00254566 Information provided by Pfizer

First Received on November 14, 2005. Last Updated on November 3, 2009 History of Changes

Results First Received: July 22, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Chronic Bronchitis
Interventions:	Other: Moxifloxacin Placebo Drug: Moxifloxacin Other: Azithromycin SR Placebo Drug: Azithromycin SR

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
398 subjects were enrolled and 396 subjects received treatment. Two subjects who were assigned to moxifloxacin did not receive at least one dose of treatment.

Reporting Groups

	Description
Azithromycin	Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
Moxifloxacin	Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.

Participant Flow: Overall Study

	Azithromycin	Moxifloxacin
STARTED	198	198
COMPLETED	167	172
NOT COMPLETED	31	26
Death	1	0
Adverse Event	5	4
Lack of Efficacy	12	9
Unknown	1	5
Withdrawal by Subject	5	6
Lost to Follow-up	7	2

Baseline Characteristics

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Reporting Groups

	Description
Azithromycin	Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
Moxifloxacin	Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.

Baseline Measures

	Azithromycin	Moxifloxacin	Total
Number of Participants [units: participants]	198	198	396
Age [units: years] Mean ± Standard Deviation	66.7 ± 8.7	67.5 ± 8.5	67.1 ± 8.6
Gender [units: participants]
Female	18	21	39
Male	180	177	357

Outcome Measures

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1. Primary:

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

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2. Secondary:

Percentage of Clinical Cure (Success) at Test of Cure Visit (Full Analysis Set) [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ]

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3. Secondary:

Percentage of Clinical Cure (Success)at Test of Cure Visit(Clinically Eligible Set) [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ]

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4. Secondary:

Percentage of Bacteriologic Response at Test of Cure Visit [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ]

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5. Secondary:

Time Taken for First Quartile (25%) of Subjects to Have AECB Recurrence [ Time Frame: Number of Days ]

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6. Secondary:

Change From Baseline in Clinical COPD Questionnaire(CCQ)Total Score [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ]

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7. Secondary:

Change From Baseline in Clinical COPD Questionnaire(CCQ)Symptoms Score [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ]

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8. Secondary:

Change From Baseline in Clinical COPD Questionnaire(CCQ)Functional State Score [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ]

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9. Secondary:

Change From Baseline in Clinical COPD Questionnaire(CCQ)Mental State Score [ Time Frame: Test of Cure (TOC) Visit (Day 12-19) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00254566 History of Changes
Other Study ID Numbers:	A0661147
Study First Received:	November 14, 2005
Results First Received:	July 22, 2009
Last Updated:	November 3, 2009
Health Authority:	Singapore: Health Sciences Authority