Bronchitis, ChronicPhase 4NCT00288223
Telithromycin in Acute Exacerbation of Chronic Bronchitis
A Phase 4 study testing Telithromycin in people with Bronchitis, Chronic, run by Sanofi at 1 site in Turkey (Türkiye).
Trial summary
Study objectives: to document the clinical efficacy of telithromycin(800 mg per day for 5 days) at Test Of the Cure (TOC)visit (D12-D19), in acute exacerbation of chronic bronchitis. to assess the long-term clinical efficacy of telithromycin by telephone at D25-D35 (V3) to assess the safety of telithromycin 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?
- Telithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2006to Jan 2007
- 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
- Outpatients,
- With a documented history of chronic bronchitis defined by one expectoration daily for at least three consecutive months over at least two consecutive years
- Presenting with an evident acute exacerbation of their disease defined by the presence of at least two of Anthonisen's criteria:
- exacerbation of dyspnea,
- increase in the expectoration volume,
- increase in the expectoration purulence,
Who cannot join
- Acute bronchitis,
- Chronic obstructive pulmonary disease, those having FEV1 value <35% (FEV1: Forced Expiratory Volume in 1 second)
- Suspected pneumonia or bronchial pneumonia,
- Paroxysmal asthma or continuous dyspnea in asthma,
- Cystic fibrosis,
- Active tuberculosis,
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- Lung cancer or lung metastasis,
- Severe bronchiectasia,
- Acute respiratory decompensation,
- Chronic respiratory insufficiency associated with resting hypoxemia,
- Patients requiring hospitalization for parenteral antibiotic treatment
- Patients with suspected or known bacterial infection other than study diseases, as well as associated systemic or intra-tracheal antibiotic treatment other than study treatment,
- Participating in another clinical study with any product within 30 days before the inclusion of study
- Known immunosuppression (AIDS and/or CD4+ lymphocytes < 200/mm3, neutropenia <1500/mm3, blood diseases or terminal stage cancer)
- Cardiovasculary, neurologic or other severe diseases interfering with the compliance with study protocol or confusing with results.
- Conditions associated with study medications:
- Hypersensitivity against telithromycin , macrolides or any of the excipients,
- Congenital long QT syndrome or family history of congenital long QT syndrome (this possibility should be excluded with normal ECG) or known acquired QT interval prolongation,
- Treatment with CYP3A4 inducers (rifampicin, carbamazepine, phenytoin, phenobarbital, St-John's-wort) within 2 weeks prior to the study inclusion
- Possibility of treatment with ergot alkaloid derivatives, terfenadine, astemizole, pimozide, cisapride, simvastatin, athorvastatin or lovastatin during studies
- Congenital galactosemia, lactase deficiency glucose or galactose malabsorption syndrome,
- Pregnant or lactating women,
- Women with childbearing potential (e.g. ovulating, pre-menopausal or not surgically sterilized) and do not employ any effective contraception method The patients may not participate to the study more than once. The patients who were treated with study drugs previously may not participate to the study.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Non Comparative Phase IV Study on the Safety and Efficacy of Telithromycin 800 mg Per Day for 5 Days in the Treatment of Acute Exacerbation of Chronic Bronchitis in Adults
Study objectives:
- to document the clinical efficacy of telithromycin(800 mg per day for 5 days) at Test Of the Cure (TOC)visit (D12-D19), in acute exacerbation of chronic bronchitis.
- to assess the long-term clinical efficacy of telithromycin by telephone at D25-D35 (V3)
- to assess the safety of telithromycin
- Conditions
- Bronchitis, Chronic
- 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
one daily intake of 800 mg (i.e. 2 x 400 mg tablets) per os in a single intake with a meal for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | telithromycin Receives: Drug: Telithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of clinical success (cure + improvement) at TOC visit (D12-19),clinical success at TOC visit in at risk sub-populations, clinical success at follow up visit (D25-35), reinfection rates,discontinuation of treatment rates, compliance
Measured: D12-D19 (efficacy assessment) and D25-D35 (telephone follow-up)
Secondary outcomes (1)
Safety assessment of telithromycin (Safety will be assessed on the basis of serious and non serious adverse events)
Measured: At V3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study startJan 2006
- Primary completionJan 2007
- Study completionJan 2007
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 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Edibe Taylan, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288223
- Sponsor's protocol ID
- HMR3647A_4022
- Status last verified
- Dec 2009
- First submitted
- 6 Feb 2006
- Last updated
- 9 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Non Comparative Phase IV Study on the Safety and Efficacy of Telithromycin 800 mg Per Day for 5 Days in the Treatment of Acute Exacerbation of Chronic Bronchitis in Adults
- ClinicalTrials.gov ID
- NCT00288223
- Acronym / sponsor ID
- HMR3647A_4022
- Conditions
- Bronchitis, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 54 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 7 Feb 2006 (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.
Study objectives:
- to document the clinical efficacy of telithromycin(800 mg per day for 5 days) at Test Of the Cure (TOC)visit (D12-D19), in acute exacerbation of chronic bronchitis.
- to assess the long-term clinical efficacy of telithromycin by telephone at D25-D35 (V3)
- to assess the safety of telithromycin
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Telithromycintelithromycin |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Outpatients,
- With a documented history of chronic bronchitis defined by one expectoration daily for at least three consecutive months over at least two consecutive years
- Presenting with an evident acute exacerbation of their disease defined by the presence of at least two of Anthonisen's criteria:
Key exclusion criteria (24 listed)
- Acute bronchitis,
- Chronic obstructive pulmonary disease, those having FEV1 value <35% (FEV1: Forced Expiratory Volume in 1 second)
- Suspected pneumonia or bronchial pneumonia,
- Paroxysmal asthma or continuous dyspnea in asthma,
- 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 |
|---|---|---|
| Telithromycinone daily intake of 800 mg (i.e. 2 x 400 mg tablets) per os in a single intake with a meal for 5 days. | Drug | 1 |
Primary outcome
Percentage of clinical success (cure + improvement) at TOC visit (D12-19),clinical success at TOC visit in at risk sub-populations, clinical success at follow up visit (D25-35), reinfection rates,discontinuation of treatment rates, compliance
Time frame: D12-D19 (efficacy assessment) and D25-D35 (telephone follow-up)
1 secondary outcome
Safety assessment of telithromycin (Safety will be assessed on the basis of serious and non serious adverse events)
Time frame: At V3
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2009.
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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.
Edibe Taylan study director
Sanofi
1 site in 1 country: 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 Bronchitis, Chronic, run by Sanofi at 1 site in Turkey (Türkiye).
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 24 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: stopped early, as of the sponsor's last update on 9 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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 was stopped early. Results are not available in the source record.
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 success (cure + improvement) at TOC visit (D12-19),clinical success at TOC visit in at risk sub-populations, clinical success at follow up visit (D25-35), reinfection rates,discontinuation of treatment rates, compliance (time frame: D12-D19 (efficacy assessment) and D25-D35 (telephone follow-up)). 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 9 Dec 2009.