Bronchitis, ChronicPhase 3NCT00649831
A Multicentre, Randomised, Open-Label Study To Compare The Efficacy And Safety Of Azithromycin For 5 Days With Those Of Amoxicillin-Clavulanic Acid In Patients With Chronic Bronchitis
A Phase 3 study testing Amoxicillin/clavulinic acid and Azithromycin in people with Bronchitis, Chronic, run by Pfizer at 31 sites in France.
Trial summary
This study compared the clinical efficacy and safety of azithromycin with that of amoxicillin-clavulanic acid, in patients between the ages of 35 and 75 years, presenting with an exacerbation of chronic bronchitis. Read more about this study
- Who is it for?
- Ages 36 to 74 years
- Conditions the study is for
- Bronchitis, Chronic
- What is being tested?
- Amoxicillin/clavulinic acid and Azithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 31 sitesFrance
- Study dates
- Oct 2002to Jun 2003
- 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 36 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients presenting with an exacerbation of chronic bronchitis including: chronic bronchitis with obstructive respiratory disorders documented by a forced expiratory volume of below 80% and higher than 35% of the theoretical value, within the previous 12 months; and thought to be of infectious origin
Who cannot join
- Patient not presenting with the associated signs of an exacerbation
- Patient presenting with clinical signs suggestive of pneumonopathy at inclusion
- Patient requiring hospitalisation in intensive care
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
France31 sites
Pfizer Investigational Site
Anzin, 59410
Pfizer Investigational Site
Avignon, 84 000
Pfizer Investigational Site
Avignon, 84000
Pfizer Investigational Site
Dijon, 21000
Pfizer Investigational Site
Équeurdreville-Hainneville, 50120
Pfizer Investigational Site
Escaudain, 59 124
Pfizer Investigational Site
Le Grand-Quevilly, 76120
Pfizer Investigational Site
Les Lilas, 93 260
Pfizer Investigational Site
Lyon, 69001
Pfizer Investigational Site
Mantes-la-Jolie, 78200
Pfizer Investigational Site
Maromme, 76150
Pfizer Investigational Site
Marseille, 13 008
Pfizer Investigational Site
Maubeuge, 59600
Pfizer Investigational Site
Mont-Saint-Martin, 54350
Pfizer Investigational Site
Nancy, 54000
Pfizer Investigational Site
Paris, 75 016
Pfizer Investigational Site
Paris, 75012
Pfizer Investigational Site
Paris, 75017
Pfizer Investigational Site
Paris, 75020
Pfizer Investigational Site
Saint-Aulaire, 19 130
Pfizer Investigational Site
Savigny, 91600
Pfizer Investigational Site
Soissons, 02 200
Pfizer Investigational Site
Tourcoing, 59200
Pfizer Investigational Site
Tulette, 26 790
Pfizer Investigational Site
Valenton, 94460
Pfizer Investigational Site
VAUX S/ Seine, 78740
Pfizer Investigational Site
Villejuif, 94800
Pfizer Investigational Site
Vincennes, 94300
Pfizer Investigational Site
Vitry, 94 400
Pfizer Investigational Site
Wattrelos, 59150
Pfizer Investigational Site
Yerres, 91330
About this study
Official title: Azithromycin (Zithromax®) 5 Days Versus Amoxicillin-Clavulanic Acid (Augmentin®): Multicentre, Randomised, Open-Label Study To Compare The Clinical Efficacy And Safety Of Azithromycin With Those Of Amoxicillin-Clavulanic Acid In Patients Presenting With An Exacerbation Of Chronic Bronchitis
This study compared the clinical efficacy and safety of azithromycin with that of amoxicillin-clavulanic acid, in patients between the ages of 35 and 75 years, presenting with an exacerbation of chronic bronchitis.
- Conditions
- Bronchitis, Chronic
- Being tested
- Amoxicillin/clavulinic acid, Azithromycin
- Medical subject headings
- Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin/clavulinic acidDrug
amoxicillin/clavulinic acid 500 mg/62.5 mg tablet; take 2 tablets by mouth twice daily (BID) for 10 days
AzithromycinDrug
Azithromycin 250 mg tablet; take 2 tablets by mouth on the first day, then 1 tablet by mouth from Days 2 to 5
| Study group | Role | What they receive |
|---|---|---|
| Group 2 | Active comparator | Not described Receives: Drug: Amoxicillin/clavulinic acid |
| Group 1 | Active comparator | Not described Receives: Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess clinical efficacy (clinical recovery or clinical failure)
Measured: Day 30
Secondary outcomes (2)
Number of exacerbations
Measured: Day 30 to Day 90
Bacteriological monitoring (a descriptive analysis of streptococci in the bacterial flora and their sensitivity to antibiotics at the different collections of sputum)
Measured: continuous
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startOct 2002
- Study completionJun 2003
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
- None (open label)
- Enrolment
- 250 participants (estimated)
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
- NCT00649831
- Sponsor's protocol ID
- A0661045
- Status last verified
- Oct 2008
- First submitted
- 27 Mar 2008
- Last updated
- 21 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azithromycin (Zithromax®) 5 Days Versus Amoxicillin-Clavulanic Acid (Augmentin®): Multicentre, Randomised, Open-Label Study To Compare The Clinical Efficacy And Safety Of Azithromycin With Those Of Amoxicillin-Clavulanic Acid In Patients Presenting With An Exacerbation Of Chronic Bronchitis
- ClinicalTrials.gov ID
- NCT00649831
- Acronym / sponsor ID
- A0661045
- Conditions
- Bronchitis, Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Study completion
- Jun 2003 (actual)
- First posted
- 1 Apr 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 compared the clinical efficacy and safety of azithromycin with that of amoxicillin-clavulanic acid, in patients between the ages of 35 and 75 years, presenting with an exacerbation of chronic bronchitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 2 | Active comparator | Drug: Amoxicillin/clavulinic acid |
| Group 1 | Active comparator | Drug: Azithromycin |
Who may qualify
- Ages
- 36 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Outpatients presenting with an exacerbation of chronic bronchitis including: chronic bronchitis with obstructive respiratory disorders documented by a forced expiratory volume of below 80% and higher than 35% of the theoretical value, within the previous 12 months; and thought to be of infectious origin
Key exclusion criteria (3 listed)
- Patient not presenting with the associated signs of an exacerbation
- Patient presenting with clinical signs suggestive of pneumonopathy at inclusion
- Patient requiring hospitalisation in intensive care
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 |
|---|---|---|
| Amoxicillin/clavulinic acidamoxicillin/clavulinic acid 500 mg/62.5 mg tablet; take 2 tablets by mouth twice daily (BID) for 10 days | Drug | Group 2 |
| AzithromycinAzithromycin 250 mg tablet; take 2 tablets by mouth on the first day, then 1 tablet by mouth from Days 2 to 5 | Drug | Group 1 |
Primary outcome
To assess clinical efficacy (clinical recovery or clinical failure)
Time frame: Day 30
2 secondary outcomes
Number of exacerbations
Time frame: Day 30 to Day 90
Bacteriological monitoring (a descriptive analysis of streptococci in the bacterial flora and their sensitivity to antibiotics at the different collections of sputum)
Time frame: continuous
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 21 Oct 2008.
- 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
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amoxicillin/clavulinic acid and Azithromycin in people with Bronchitis, Chronic, run by Pfizer at 31 sites in France.
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 3 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 21 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in France. 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?
To assess clinical efficacy (clinical recovery or clinical failure) (time frame: Day 30). 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 21 Oct 2008.