Chronic BronchitisPhase 4NCT00132938
PERSPECTIVE: Telithromycin - Acute Exacerbation of Chronic Bronchitis
A Phase 4 study testing telithromycin in people with Chronic Bronchitis, run by Sanofi at 8 sites in 8 countries.
Trial summary
Primary Objective: The primary objective of the study is to demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in the reduction of Streptococcus pneumoniae (Sp) strains resistant to beta-lactams or macrolides at the Test of Cure (TOC) visit in the sputum of patients with Sp… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Chronic Bronchitis
- What is being tested?
- telithromycin
- How many people
- 5,660 participants
- Where
- 8 sitesin 8 countries
- Study dates
- Jan 2004to May 2006
- Phase
- Phase 4
- 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
- Patients meeting all of the following criteria will be considered for enrollment into the study:
- Outpatients, male or female, aged 35 years or older
- Patients with a documented history of chronic bronchitis, characterized by cough and excessive sputum production for most days of at least three months for 2 consecutive years
- Patients with a clinical diagnosis of acute exacerbation of chronic bronchitis (AECB), presumed due to bacterial infection based on increased sputum purulence with either increased dyspnea or sputum volume
- Patients producing spontaneous sputum
- Patients with three or less AECB in the previous 12 months
Who cannot join
- Patients presenting with any of the following will not be included in the study:
- Patients with a known diagnosis of bronchiectasis; cystic fibrosis; lung cancer or lung metastases; active pulmonary tuberculosis; or with suspected pneumonia.
- Patients with present acute respiratory failure or patients requiring aggressive airway management
- Hospitalized patients and patients from institutional care facilities
- Patients treated with antibiotics within 14 days prior to enrollment
- Patients who are receiving other medications, including systemic antimicrobial agents; or who have other disease conditions or infections that could interfere with the evaluation of drug efficacy or safety.
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- Patients with a concomitant condition (including clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease) making either implementation of the protocol or interpretation of the study results difficult
- Patients with a progressively fatal disease, or life expectancy ≤ three months
- Patients who have received any other investigational drug within 1 month prior to study entry, or have such treatment planned for the study period
- Patients with a recent (within the previous three months) history of alcohol or drug abuse
- Immunocompromised patients including, but not limited to: patients with known HIV infection (CD4 + <200/mm3); known neutropenia (<1500 neutrophils/mm3); chronic corticosteroid therapy (≥ 10mg/day prednisolone equivalent during at least three months); immunodepressant treatment within the previous six months; splenectomized patients or patients with known hyposplenia or asplenia.
- Patients with mental conditions rendering them unable to understand the nature, scope, and possible consequences of the study
- Patients unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and are unlikely to complete the study
- Patients having received anti-pneumococcal immunization in the previous six months before study entry
- Patients with suspected or known hypersensitivity to, or suspected serious adverse reactions to the study medication, or to ß-lactams or macrolide classes of antibiotics
- Patients diagnosed with myasthenia gravis
- Women who are breast-feeding or who are pregnant
- Women who are of childbearing potential who do not agree to use an approved contraceptive method during the study
- Patients with galactose intolerance, lactase deficiency or glucose-galactose malabsorption
- Patients with a known history of long QTc syndrome (e.g., personal or family history of syncope or arrhythmia)
- Patients treated within 2 weeks prior to study entry, or requiring treatment during study medication, with CYP3A4 inducers such as rifampicin, phenytoin, carbamazepine, phenobarbital, and St John's wort
- Patients requiring treatment during the study period with drugs not permitted by the clinical study protocol
- Patients known to have impaired hepatic function
- Patients known to have impaired renal function
- Patients already enrolled in this study
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
About this study
Official title: An Open-label, Randomized, Multicenter, Clinical Study to Compare the Effects of Telithromycin, Azithromycin and Cefuroxime Axetil on the Penicillin or Macrolide Resistance of Streptococcus Pneumoniae in Patients With Acute Exacerbation of Chronic Bronchitis
Primary Objective:
- The primary objective of the study is to demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in the reduction of Streptococcus pneumoniae (Sp) strains resistant to beta-lactams or macrolides at the Test of Cure (TOC) visit in the sputum of patients with Sp detected at the start of the study (Visit 1).
Read more
Secondary Objectives:
The secondary objectives of the study are:
- To demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in achieving clinical cure and Sp eradication success at the Test of Cure visit in patients with Sp detected in sputum specimen at the start of the study (Visit 1);
- To compare the clinical cure rates achieved by each treatment group in the penicillin or erythromycin resistant Sp (PERSp) population with the cure rates in the sensitive Sp (SSp) population at the End of Therapy (EOT) and Test of Cure visits;
- To compare the effect of telithromycin, azithromycin and cefuroxime axetil at the End of Therapy visit on the presence of Streptococcus pneumoniae strains resistant to beta-lactams or macrolides in the sputum of patients with Sp detected at the start of the study (Visit 1);
- To compare the clinical efficacy at the End of Therapy visit and safety at the Test of Cure visit of telithromycin, azithromycin and cefuroxime axetil in the "global" randomized population.
- Conditions
- Chronic Bronchitis
- Being tested
- telithromycin
- Medical subject headings
- Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telithromycinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of PERSp in sputum of patients at the TOC visit in each treatment group and who were Sp positive in sputum at Visit 1.
Secondary outcomes (1)
Assessment of clinical signs and symptoms of AECB at EOT visit for the global efficacy analysis population & at TOC visit for patients who were Sp positive in sputum at visit 1.Bacteriological data at EOT and TOC visits. Assessment of safety...
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study startJan 2004
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic BronchitisStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,660 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gilles Perdriset, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132938
- Sponsor's protocol ID
- HMR3647A_4020
- Other IDs
- EudraCT # :2004-001412-30
- Status last verified
- Jun 2011
- First submitted
- 18 Aug 2005
- Last updated
- 8 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Multicenter, Clinical Study to Compare the Effects of Telithromycin, Azithromycin and Cefuroxime Axetil on the Penicillin or Macrolide Resistance of Streptococcus Pneumoniae in Patients With Acute Exacerbation of Chronic Bronchitis
- ClinicalTrials.gov ID
- NCT00132938
- Acronym / sponsor ID
- HMR3647A_4020
- Conditions
- Chronic Bronchitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,660 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 22 Aug 2005 (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.
Primary Objective:
- The primary objective of the study is to demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in the reduction of Streptococcus pneumoniae (Sp) strains resistant to beta-lactams or macrolides at the Test of Cure (TOC) visit in the sputum of patients with Sp detected at the start of the study (Visit 1).
Secondary Objectives:
The secondary objectives of the study are:
- To demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in achieving clinical cure and Sp eradication success at the Test of Cure visit in patients with Sp detected in sputum specimen at the start of the study (Visit 1);
- To compare the clinical cure rates achieved by each treatment group in the penicillin or erythromycin resistant Sp (PERSp) population with the cure rates in the sensitive Sp (SSp) population at the End of Therapy (EOT) and Test of Cure visits;
- To compare the effect of telithromycin, azithromycin and cefuroxime axetil at the End of Therapy visit on the presence of Streptococcus pneumoniae strains resistant to beta-lactams or macrolides in the sputum of patients with Sp detected at the start of the study (Visit 1);
- To compare the clinical efficacy at the End of Therapy visit and safety at the Test of Cure visit of telithromycin, azithromycin and cefuroxime axetil in the "global" randomized population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients meeting all of the following criteria will be considered for enrollment into the study:
- Outpatients, male or female, aged 35 years or older
- Patients with a documented history of chronic bronchitis, characterized by cough and excessive sputum production for most days of at least three months for 2 consecutive years
- Patients with a clinical diagnosis of acute exacerbation of chronic bronchitis (AECB), presumed due to bacterial infection based on increased sputum purulence with either increased dyspnea or sputum volume
- Patients producing spontaneous sputum
Key exclusion criteria (25 listed)
- Patients with a known diagnosis of bronchiectasis; cystic fibrosis; lung cancer or lung metastases; active pulmonary tuberculosis; or with suspected pneumonia.
- Patients with present acute respiratory failure or patients requiring aggressive airway management
- Hospitalized patients and patients from institutional care facilities
- Patients treated with antibiotics within 14 days prior to enrollment
- Patients who are receiving other medications, including systemic antimicrobial agents; or who have other disease conditions or infections that could interfere with the evaluation of drug efficacy or safety.
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 |
|---|---|---|
| telithromycin | Drug | – |
Primary outcome
Presence of PERSp in sputum of patients at the TOC visit in each treatment group and who were Sp positive in sputum at Visit 1.
1 secondary outcome
Assessment of clinical signs and symptoms of AECB at EOT visit for the global efficacy analysis population & at TOC visit for patients who were Sp positive in sputum at visit 1.Bacteriological data at EOT and TOC visits. Assessment of safety...
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 8 Jun 2011.
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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.
Gilles Perdriset, MD study director
Sanofi
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing telithromycin in people with Chronic Bronchitis, run by Sanofi at 8 sites in 8 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 6 inclusion and 25 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 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Belgium, France, Hungary, Morocco and 3 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Presence of PERSp in sputum of patients at the TOC visit in each treatment group and who were Sp positive in sputum at Visit 1.. 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 8 Jun 2011.