Bronchitis, ChronicPhase 3NCT00644449
A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Acute Symptoms of Chronic Bronchitis
A Phase 3 study testing azithromycin SR (Zithromax; compound: CP-62,993) and levofloxacin in people with Bronchitis, Chronic, run by Pfizer at 75 sites in 13 countries.
Trial summary
This study was performed to confirm that a single 2.0-g dose of azithromycin SR is at least as effective as 7 days of levofloxacin 500 mg/day in adults with acute exacerbation of chronic bronchitis Secondary objectives: To assess safety and the bacteriologic efficacy of both treatment regimens Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Bronchitis, Chronic
- What is being tested?
- azithromycin SR (Zithromax; compound: CP-62,993) and levofloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 551 participants
- Where
- 75 sitesin 13 countries
- Study dates
- Jan 2003to Mar 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with a history of chronic bronchitis (i.e., chronic cough and sputum production on most days for 3 consecutive months for more than 2 years) and current evidence of an acute bacterial exacerbation of their disease, as demonstrated by production of purulent sputum and the presence of at lest 2 of the following signs and symptoms, were included: increased sputum production, increased dypsnea, increased cough, or increased sputum purulence.
Who cannot join
- Key exclusion criteria were treatment with any systemic antibiotic within the previous 7 days, or the likelihood of receiving other systemic antibiotics during participation in the study; a chest radiograph consistent with pneumonia; and previously diagnosed conditions which tend to mimic or complicate the course and evaluation of the infectious process (e.g., bronchiectasis, lung abscess or empyema, active TB, pulmonary malignancy, cystic fibrosis).
Trial locations and contacts
75 sites in 13 countries.
75 sites in 13 countries
United States29 sites
Pfizer Investigational Site
Allentown, Pennsylvania, 18102
Pfizer Investigational Site
Austell, Georgia, 30106
Pfizer Investigational Site
Birmingham, Alabama, 35215
Pfizer Investigational Site
Birmingham, Alabama, 35233
Pfizer Investigational Site
Columbiana, Alabama, 35051
Pfizer Investigational Site
Columbus, Ohio, 43214
Pfizer Investigational Site
Columbus, Ohio, 43215
Pfizer Investigational Site
Columbus, Ohio, 43222
Pfizer Investigational Site
Daytona Beach, Florida, 32114
Pfizer Investigational Site
Elkhorn, Nebraska, 68022
Pfizer Investigational Site
Evansville, Indiana, 47712
Pfizer Investigational Site
Harrisburg, Pennsylvania, 17011
Pfizer Investigational Site
Harrisburg, Pennsylvania, 17110
Pfizer Investigational Site
Kalamazoo, Michigan, 49009
Pfizer Investigational Site
Madisonville, Kentucky, 42431
Pfizer Investigational Site
Merritt Island, Florida, 32953
Pfizer Investigational Site
Mesa, Arizona, 85201
Pfizer Investigational Site
Milan, Tennessee, 38358
Pfizer Investigational Site
Morrisville, Pennsylvania, 19067
Pfizer Investigational Site
New Orleans, Louisiana, 70115
Pfizer Investigational Site
Olive Branch, Mississippi, 38654
Pfizer Investigational Site
Omaha, Nebraska, 68105
Pfizer Investigational Site
Omaha, Nebraska, 68144
Pfizer Investigational Site
Phoenix, Arizona, 85014
Pfizer Investigational Site
Royal Oak, Michigan, 48073
Pfizer Investigational Site
San Antonio, Texas, 78224
Pfizer Investigational Site
Tallassee, Alabama, 36078
Pfizer Investigational Site
Tempe, Arizona, 85282
Pfizer Investigational Site
Willow Grove, Pennsylvania, 19090
Canada8 sites
Pfizer Investigational Site
Edmonton, Alberta, T5A 4L8
Pfizer Investigational Site
Edmonton, Alberta, T5N 2N8
Pfizer Investigational Site
Hawkesbury, Ontario, K6A 1A1
Pfizer Investigational Site
North Battleford, Saskatchewan, S9A 0V6
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7K 3H3
Pfizer Investigational Site
Ste-Foy, Quebec, G1V 4G5
Pfizer Investigational Site
Sydney, Nova Scotia, B1S 1A9
Pfizer Investigational Site
Toronto, Ontario, M9W 4L6
Brazil6 sites
Pfizer Investigational Site
Curitiba, Paraná, 80060-900
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-002
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-003
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-074
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90610-000
Pfizer Investigational Site
Santo André, São Paulo, 09060-650
Costa Rica6 sites
Pfizer Investigational Site
Desamparados, Provincia de San José
Pfizer Investigational Site
Guadalupe, Provincia de San José
Pfizer Investigational Site
Pavas, Provincia de San José
Pfizer Investigational Site
Pinares de Curridabat, Provincia de San José
Pfizer Investigational Site
San José, Provincia de San José
Pfizer Investigational Site
Uruca, Provincia de San José
India6 sites
Pfizer Investigational Site
Bangalore, Karnataka, 560 034
Pfizer Investigational Site
Coimbatore, Tamil Nadu, 641022
Pfizer Investigational Site
Elamakkara, Cochin, Kerala, 682 026
Pfizer Investigational Site
Indore, Madhya Pradesh, 452 001
Pfizer Investigational Site
Ludhiana, Punjab, 141 001
Pfizer Investigational Site
Pune, Maharashtra, 411 053
Russia6 sites
Pfizer Investigational Site
Moscow, 105077
Pfizer Investigational Site
Moscow, 105229
Pfizer Investigational Site
Moscow, 107066
Pfizer Investigational Site
Moscow, 119048
Pfizer Investigational Site
Moscow
Pfizer Investigational Site
Smolensk, 214019
Lithuania3 sites
Pfizer Investigational Site
Alytus, LT-4580
Pfizer Investigational Site
Klaipėda, LT-5800
Pfizer Investigational Site
Vilnius, LT-2010
Spain3 sites
Pfizer Investigational Site
Madrid, 28006
Pfizer Investigational Site
Madrid, 28007
Pfizer Investigational Site
Málaga, 29010
United Kingdom3 sites
Pfizer Investigational Site
Atherstone, Warwickshire, CV9 1EU
Pfizer Investigational Site
Glasgow, G45 9AW
Pfizer Investigational Site
Leeds, West Yorkshire, LS12 1JE
Germany2 sites
Pfizer Investigational Site
Berlin, 10965
Pfizer Investigational Site
Rathenow, 14712
About this study
Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Levofloxacin for the Treatment of Acute Exacerbation of Chronic Bronchitis (AECB)
This study was performed to confirm that a single 2.0-g dose of azithromycin SR is at least as effective as 7 days of levofloxacin 500 mg/day in adults with acute exacerbation of chronic bronchitis Secondary objectives: To assess safety and the bacteriologic efficacy of both treatment regimens
- Conditions
- Bronchitis, Chronic
- Being tested
- placebo, azithromycin SR (Zithromax; compound: CP-62,993), levofloxacin
- Medical subject headings
- Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
placebo
azithromycin SR (Zithromax; compound: CP-62,993)Drug
azithromycin 2.0 g by mouth in the form of a slurry for 1 dose
placeboOther
placebo
levofloxacinDrug
500 mg (two 250 mg capsules) by mouth once daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Other: placebo; Drug: azithromycin SR (Zithromax; compound: CP-62,993) |
| 2 | Experimental | Not described Receives: Other: placebo; Drug: levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
sponsor assessment of clinical response in the Clinical Per Protocol population
Measured: Test of Cure (TOC) visit (Day 14-21)
Secondary outcomes (9)
investigator assessment of clinical response in the Clinical Per Protocol population
Measured: TOC visit
bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population
Measured: TOC visit
sponsor assessment of clinical response in the Clinical Per Protocol population
Measured: Long-Term Follow-Up (LTFU) visit (Day 28-35)
Summary of baseline susceptibilities
Measured: Study Endpoint
adverse events
Measured: Continuous
clinical laboratory tests
Measured: Baseline and EOT visit
sponsor assessment of clinical response in the Clinical Per Protocol population
Measured: End of Treatment (EOT) visit (Day 8-11)
sponsor assessment of clinical response in the remaining study populations
Measured: TOC visit
sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population
Measured: EOT visit and TOC visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startJan 2003
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchitis, ChronicStudies 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
- 551 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644449
- Sponsor's protocol ID
- A0661102
- Status last verified
- May 2011
- First submitted
- 19 Mar 2008
- Last updated
- 16 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Levofloxacin for the Treatment of Acute Exacerbation of Chronic Bronchitis (AECB)
- ClinicalTrials.gov ID
- NCT00644449
- Acronym / sponsor ID
- A0661102
- Conditions
- Bronchitis, Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 551 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Study completion
- Mar 2004 (actual)
- First posted
- 26 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was performed to confirm that a single 2.0-g dose of azithromycin SR is at least as effective as 7 days of levofloxacin 500 mg/day in adults with acute exacerbation of chronic bronchitis Secondary objectives: To assess safety and the bacteriologic efficacy of both treatment regimens
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: placebo, Drug: azithromycin SR (Zithromax; compound: CP-62,993) |
| 2 | Experimental | Other: placebo, Drug: levofloxacin |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with a history of chronic bronchitis (i.e., chronic cough and sputum production on most days for 3 consecutive months for more than 2 years) and current evidence of an acute bacterial exacerbation of their disease, as demonstrated by production of purulent sputum and the presence of at lest 2 of the following signs and symptoms, were included: increased sputum production, increased dypsnea, increased cough, or increased sputum purulence.
Key exclusion criteria (1 listed)
- Key exclusion criteria were treatment with any systemic antibiotic within the previous 7 days, or the likelihood of receiving other systemic antibiotics during participation in the study; a chest radiograph consistent with pneumonia; and previously diagnosed conditions which tend to mimic or complicate the course and evaluation of the infectious process (e.g., bronchiectasis, lung abscess or empyema, active TB, pulmonary malignancy, cystic fibrosis).
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 |
|---|---|---|
| placeboplacebo | Other | 1 |
| azithromycin SR (Zithromax; compound: CP-62,993)azithromycin 2.0 g by mouth in the form of a slurry for 1 dose | Drug | 1 |
| placeboplacebo | Other | 2 |
| levofloxacin500 mg (two 250 mg capsules) by mouth once daily for 7 days | Drug | 2 |
Primary outcome
sponsor assessment of clinical response in the Clinical Per Protocol population
Time frame: Test of Cure (TOC) visit (Day 14-21)
9 secondary outcomes
investigator assessment of clinical response in the Clinical Per Protocol population
Time frame: TOC visit
bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population
Time frame: TOC visit
sponsor assessment of clinical response in the Clinical Per Protocol population
Time frame: Long-Term Follow-Up (LTFU) visit (Day 28-35)
Summary of baseline susceptibilities
Time frame: Study Endpoint
adverse events
Time frame: Continuous
clinical laboratory tests
Time frame: Baseline and EOT visit
sponsor assessment of clinical response in the Clinical Per Protocol population
Time frame: End of Treatment (EOT) visit (Day 8-11)
sponsor assessment of clinical response in the remaining study populations
Time frame: TOC visit
sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population
Time frame: EOT visit and TOC visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
75 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing azithromycin SR (Zithromax; compound: CP-62,993) and levofloxacin in people with Bronchitis, Chronic, run by Pfizer at 75 sites in 13 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 1 inclusion and 1 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 16 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in United States, Canada, Brazil, Costa Rica, India and 8 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
sponsor assessment of clinical response in the Clinical Per Protocol population (time frame: Test of Cure (TOC) visit (Day 14-21)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2011.