Chronic BronchitisPhase 3NCT00254566

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

A Phase 3 study testing Moxifloxacin and Azithromycin SR in people with Chronic Bronchitis, run by Pfizer at 34 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 50 years and older
Conditions the study is for: Chronic Bronchitis
What is being tested?: Moxifloxacin and Azithromycin SR
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 398 participants
Where: 34 sitesin 6 countries
Study dates: Feb 2006to Aug 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

34 sites in 6 countries.

Country

City, postcode or hospital

34 sites in 6 countries

China15 sites

Pfizer Investigational Site
Beijing, 100034
Pfizer Investigational Site
Beijing, 100083
Pfizer Investigational Site
Chongqing, 400016
Pfizer Investigational Site
Chongqing, 400037
Pfizer Investigational Site
Guangzhou, Guangdong, 510080
Pfizer Investigational Site
Hangzhou, Zhejiang, 310009
Pfizer Investigational Site
Hangzhou, 310003
Pfizer Investigational Site
Nanjing, Jiangsu, 210002
Pfizer Investigational Site
Shanghai, 200025
Pfizer Investigational Site
Shanghai, 200040
Pfizer Investigational Site
Shanghai, 200080
Pfizer Investigational Site
Shenyang, Liaoning, 110016
Pfizer Investigational Site
Shijiazhuang, Hebei, 050000
Pfizer Investigational Site
Xi’an, Shanxi, 710032
Pfizer Investigational Site
Xi’an, Shanxi, 710061

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Thailand6 sites

Pfizer Investigational Site
Bangkok, 10110
Pfizer Investigational Site
Bangkok, 10700
Pfizer Investigational Site
Chiang Mai, 50200
Pfizer Investigational Site
Khon Kaen, 40002
Pfizer Investigational Site
Maerim, Chiangmai, 50180
Pfizer Investigational Site
Vachira Dusit, Bangkok, 10330

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Taiwan5 sites

Pfizer Investigational Site
Kuei Shan Hsiang, Taoyuan Hsien, 333
Pfizer Investigational Site
Neihu, Taipei, 114
Pfizer Investigational Site
Taichung, 404
Pfizer Investigational Site
Taichung, 40705
Pfizer Investigational Site
Taipei, 100

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Philippines4 sites

Pfizer Investigational Site
Manila, 1000
Pfizer Investigational Site
Manila, 1008
Pfizer Investigational Site
Quezon City, 1100
Pfizer Investigational Site
Quezon City, 1104

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Malaysia2 sites

Pfizer Investigational Site
Cheras, Kuala Lumpur, 56000
Pfizer Investigational Site
Lembah Pantai, Kuala Lumpur, 50603

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Singapore2 sites

Pfizer Investigational Site
Singapore, Singapore, 169608
Pfizer Investigational Site
Singapore, 308433

Other trials in Singapore

About this 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).

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

Conditions: Chronic Bronchitis
Being tested: Moxifloxacin Placebo, Moxifloxacin, Azithromycin SR Placebo, Azithromycin SR
Keywords: Azithromycin SR; Moxifloxacin; Acute exacerbation of chronic bronchitis (AECB)
Medical subject headings: Bronchitis, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Moxifloxacin PlaceboOther
1 capsule once daily for 5 days
MoxifloxacinDrug
1 X 400mg capsule once daily for 5 days
Azithromycin SR PlaceboOther
single dose, oral.
Azithromycin SRDrug
single dose 2.0 g oral

Study groups in NCT00254566
Study group	Role	What they receive
1	Experimental	Not described Receives: Other: Azithromycin SR Placebo; Drug: Azithromycin SR
2	Active comparator	Not described Receives: Other: Moxifloxacin Placebo; Drug: Moxifloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Clinical Cure (Success) at Test of Cure Visit(Clinical Per Protocol Population)
Cure=Signs\&symptoms(S\&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S\&S of acute infection persisted/worsened,new clinical S\&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub
Measured: Test of Cure (TOC) Visit (Day 12-19)

Secondary outcomes (8)

Percentage of Clinical Cure (Success) at Test of Cure Visit (Full Analysis Set)
Clinical response (Cure vs Failure) at the TOC visit for the Full Analysis Set (FAS), Cure=Signs\&symptoms(S\&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S\&S of acute infection persisted/worsened,new clinical S\&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub
Measured: Test of Cure (TOC) Visit (Day 12-19)
Percentage of Clinical Cure (Success)at Test of Cure Visit(Clinically Eligible Set)
Clinical Response at TOC Visit for clinically Eligible Subjects, Cure=Signs\&symptoms(S\&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S\&S of acute infection persisted/worsened,new clinical S\&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub
Measured: Test of Cure (TOC) Visit (Day 12-19)
Percentage of Bacteriologic Response at Test of Cure Visit
Bacteriogical response assessed on per pathogen basis for Bacteriologic Per Protcol (BPP) set at TOC Visit. If no repeat culture, response is presumed from sponsor assessment of clinical response. Eradication =# of pathogens eradicated at TOC/N; Persistence =# of pathogens persistent at TOC/N; N=# of unique pathogens identified at baseline
Measured: Test of Cure (TOC) Visit (Day 12-19)
Time Taken for First Quartile (25%) of Subjects to Have AECB Recurrence
Subject is considered to have AECB recurrence if they had a clinical response of cure at the TOC visit and then met the definition of AECB during the follow-up period.
Measured: Number of Days
Change From Baseline in Clinical COPD Questionnaire(CCQ)Total Score
CCQ was developed to measure health status of Chronic obstructive pulmonary disease (COPD) subjects. 10 items divided into 3 domains: symtoms, functional state, and mental state. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely symptomatic/totally limited; change=mean score at observation minus mean score at baseline
Measured: Test of Cure (TOC) Visit (Day 12-19)
Change From Baseline in Clinical COPD Questionnaire(CCQ)Symptoms Score
1 of 3 domains that combined into the CCQ Total score. Items 1,2,5,and 6 address symptoms. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely symptomatic; change=mean score at observation minus mean score at baseline
Measured: Test of Cure (TOC) Visit (Day 12-19)
Change From Baseline in Clinical COPD Questionnaire(CCQ)Functional State Score
1 of 3 domains that combined into the CCQ Total score. Items 7,8,9, and 10 address functional state. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely; change=mean score at observation minus mean score at baseline
Measured: Test of Cure (TOC) Visit (Day 12-19)
Change From Baseline in Clinical COPD Questionnaire(CCQ)Mental State Score
1 of 3 domains that combined into the CCQ Total score. Items 3 and 4 address mental state. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely; change=mean score at observation minus mean score at baseline
Measured: Test of Cure (TOC) Visit (Day 12-19)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2006Aug 2008

First posted16 Nov 2005 (estimated)
Study startFeb 2006
Primary completionAug 2008
Study completionAug 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic BronchitisStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 398 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00254566
Sponsor's protocol ID: A0661147
Status last verified: Nov 2009
First submitted: 14 Nov 2005
Last updated: 11 Nov 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Bronchitis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

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).
ClinicalTrials.gov ID: NCT00254566
Acronym / sponsor ID: A0661147
Conditions: Chronic Bronchitis
Keywords: Azithromycin SR; Moxifloxacin; Acute exacerbation of chronic bronchitis (AECB)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 398 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Feb 2006
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 16 Nov 2005 (estimated)
Results: Posted 2 Sep 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Other: Azithromycin SR Placebo, Drug: Azithromycin SR
2	Active comparator	Other: Moxifloxacin Placebo, Drug: Moxifloxacin

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Moxifloxacin Placebo1 capsule once daily for 5 days	Other	2
Moxifloxacin1 X 400mg capsule once daily for 5 days	Drug	2
Azithromycin SR Placebosingle dose, oral.	Other	1
Azithromycin SRsingle dose 2.0 g oral	Drug	1

Primary outcome

Percentage of Clinical Cure (Success) at Test of Cure Visit(Clinical Per Protocol Population)
Time frame: Test of Cure (TOC) Visit (Day 12-19)
Cure=Signs\&symptoms(S\&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S\&S of acute infection persisted/worsened,new clinical S\&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub

8 secondary outcomes

Percentage of Clinical Cure (Success) at Test of Cure Visit (Full Analysis Set)
Time frame: Test of Cure (TOC) Visit (Day 12-19)
Percentage of Clinical Cure (Success)at Test of Cure Visit(Clinically Eligible Set)
Time frame: Test of Cure (TOC) Visit (Day 12-19)
Percentage of Bacteriologic Response at Test of Cure Visit
Time frame: Test of Cure (TOC) Visit (Day 12-19)
Time Taken for First Quartile (25%) of Subjects to Have AECB Recurrence
Time frame: Number of Days
Change From Baseline in Clinical COPD Questionnaire(CCQ)Total Score
Time frame: Test of Cure (TOC) Visit (Day 12-19)
Change From Baseline in Clinical COPD Questionnaire(CCQ)Symptoms Score
Time frame: Test of Cure (TOC) Visit (Day 12-19)
Change From Baseline in Clinical COPD Questionnaire(CCQ)Functional State Score
Time frame: Test of Cure (TOC) Visit (Day 12-19)
Change From Baseline in Clinical COPD Questionnaire(CCQ)Mental State Score
Time frame: Test of Cure (TOC) Visit (Day 12-19)

Results and safety

Results posted to the registry on 2 Sep 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Azithromycin	198	167
Moxifloxacin	198	172

Primary outcome: Percentage of Clinical Cure (Success) at Test of Cure Visit(Clinical Per Protocol Population)

Time frame: Test of Cure (TOC) Visit (Day 12-19). Number. Unit: percent

Measure	Azithromycin n = 187	Moxifloxacin n = 191
Cure	93.0	94.2
Failure	7.0	5.8

Azithromycin vs Moxifloxacin: Risk Difference (RD): -0.9 (95% CI -5.8 to 3.9)

Population analysed: Clinical Per Protocol-all randomized subjects who were clinically eligible; received at least 80% of study med; no concomitant systemic antibiotics with activity against Acute Exacerbation of Chronic Bronchitis (AECB) pathogens, assessment made in appropriate visit window.

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Azithromycin	4 of ?	32 of ?	Not reported
Moxifloxacin	9 of ?	19 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Chronic Bronchitis

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Study Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis
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Recruiting
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

34 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Moxifloxacin and Azithromycin SR in people with Chronic Bronchitis, run by Pfizer at 34 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in China, Thailand, Taiwan, Philippines, Malaysia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Clinical Cure (Success) at Test of Cure Visit(Clinical Per Protocol Population) (time frame: Test of Cure (TOC) Visit (Day 12-19)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00254566.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2009.