Chronic Obstructive Pulmonary DiseasePhase 4TRANCENCT00495586
Effectiveness of Antibiotic Therapy for Exacerbations of Chronic Obstructive Pulmonary Disease
A Phase 4 study testing Amoxicillin and clavulanic acid in people with Chronic Obstructive Pulmonary Disease, run by Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC) at 13 sites in Spain.
Trial summary
The purpose of this study is to determine the effectiveness of antibiotic therapy for patients with acute exacerbations of mild-to-moderate chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Amoxicillin and clavulanic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 318 participants
- Where
- 13 sitesSpain
- Study dates
- Oct 2007to Jul 2011
- Phase
- Phase 4
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute exacerbations (at least one criterion present: increase of dyspnoea, increase of sputum production and/or increase of purulence) of
- patients older than 40 years old,
- smokers or ex-smokers of more than 10 pack-years,
- with COPD and FEV1 greater than 50%, diagnosed by spirometry and a predicted ratio FEV1/FVC<0.7%.
Who cannot join
- Severe COPD (FEV1<50%)
- Pneumonia
- Active neoplasm
- Tracheotomy
- Criteria for hospitalisation
- Patients previously being on antibiotics
Show all 11Show fewer
- Immunodepressed patients
- History of hypersensitivity to beta-lactams or intolerance to clavulanate
- Enrollment in other clinical trials
- Patients who refuse to take part in this study
- Patients who have not had a spirometry test for the past two years
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Spain13 sites
Hospital Clínic
Barcelona, Catalonia, 08036
Primary Healthcare Center La Marina
Barcelona, Catalonia, 08038
Primary Healthcare Center Figueres
Figueres, Catalonia, 17600
Primary Healthcare Center Montilivi
Girona, Catalonia, 17003
Primary Healthcare Center Girona-4
Girona, Catalonia, 17007
Primary Healthcare Centre Breda-Hostalric
Hostalric, Catalonia, 17450
Primary Healthcare Center Lleida
Lleida, Catalonia, 25001
Primary Healthcare Centre Molins de Rei
Molins de Rey, Catalonia, 08750
Primary Healthcare Centre Olot
Olot, Catalonia, 17800
Primary Healthcare Center Reus-3
Reus, Catalonia, 43203
Primary Healthcare Center Les Muralles
Tarragona, Catalonia, 43003
Primary Healthcare Centre Jaume I
Tarragona, Catalonia, 43005
Primary Healthcare Center Valls Urbà
Valls, Catalonia, 43600
About this study
Official title: Situations That do Not Require Antibiotics for Acute Exacerbations of Mild-to-moderate Chronic Obstructive Pulmonary Disease
The purpose of this study is to determine the effectiveness of antibiotic therapy for patients with acute exacerbations of mild-to-moderate chronic obstructive pulmonary disease.
Read the detailed description
Antibiotics are usually prescribed for acute exacerbations of chronic obstructive pulmonary disease (COPD) even though their benefit in mild-to-moderate COPD is not demonstrated. The aim of this study is to assess the effectiveness of antibiotic therapy for exacerbations of COPD, what clinical variables are associated with an improved clinical response with antibiotic therapy with respect to placebo and to identify which patients might recover from an acute exacerbation without antibiotic therapy. Methodology: prospective, randomised, double blind, placebo-controlled clinical trial, in which exacerbations (at least one criterion present: increase of dyspnoea, increase of sputum production and/or increase of purulence) of patients older than 40 yr., smokers or ex-smokers of more than 10 pack-years, with COPD and FEV1 greater than 50%, diagnosed by spirometry and a predicted ratio FEV1/FVC<0.7%. Exclusion criteria: severe COPD (FEV1<50%), active neoplasm, tracheotomy, pneumonia, hospitalization criteria, patients previously being on antibiotics, immunodepressed, history of hypersensitivity to beta-lactams or intolerance to clavulanate, enrollment in other clinical trials, patients who refuse to take part in this study, and patients who have not had a spirometry test for the past two years. Sample size: 677 patients. Interventions: first visit: the patient will be given details of the clinical trial and will be asked to sign informed consent; other data: sputum color, chest X-ray ordered to rule out pneumonia, C-reactive protein levels, and peak flow measurement. The patient will be randomised to receive amoxicillin plus clavulanate or placebo and will be scheduled to return for a 2nd follow-up visit after 3 or 4 days to assess the clinical response and peak flow measurements and to rule out any worsening of the condition. Third visit: scheduled after 9-11 days to assess the clinical response, drug-compliance and peak flow measurement. Fourth visit after 15-20 days for clinical assessment and to observe whether any relapses have occurred. Date of the following exacerbation will be recorded.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Placebo, Amoxicillin and clavulanic acid
- Keywords
- COPD, Antibiotics
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called It's placebo
One pill to be taken every eight hours for 8 days
Amoxicillin and clavulanic acidDrug
Also called Augmentine 500-125 mg 24 pills
500-125 mg to be taken every eight hours for 8 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo pills t.i.d. for 8 days Receives: Drug: Placebo |
| Amoxycillin and clavulanic acid | Active comparator | Amoxycillin and clavulanate t.i.d. for 8 days Receives: Drug: Amoxicillin and clavulanic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Were Cured
Cure defined as the disappearance of the acute signs and symptoms related to the infection, with complete return to the previous situation of stability
Measured: Day 9-11
Secondary outcomes (1)
Number of Days Till the Next Exacerbation
For the assessment of the time till next exacerbation patients were monitored over a period of 365 days on a three-monthly basis. Patients were instructed to contact their physician immediately if there was any change in their health status. Diagnosis of a new exacerbation was based on the same clinical criteria described previously. For the calculation of time to the next exacerbation, all clinical failures occurring during therapy were counted as zero exacerbation-free interval days.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2007 (estimated)
- Study startOct 2007
- Primary completionJul 2010
- Study completionJul 2011
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria
- Responsible party
- Principal investigator, Carl Llor, Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)
- Investigators
- Carl Llor, Doctor, Principal investigator, Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)Marc Miravitlles, Doctor, Study director, Hospital ClinicAna Moragas, Family doc., Study director, Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00495586
- Sponsor's protocol ID
- P06/31
- Acronym
- TRANCE
- Status last verified
- Mar 2012
- First submitted
- 2 Jul 2007
- Last updated
- 13 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Miravitlles M, Moragas A, Hernandez S, Bayona C, Llor C. Is it possible to identify exacerbations of mild to moderate COPD that do not require antibiotic treatment? Chest. 2013 Nov;144(5):1571-1577. doi: 10.1378/chest.13-0518.
PubMed 23807094Llor C, Moragas A, Hernandez S, Bayona C, Miravitlles M. Efficacy of antibiotic therapy for acute exacerbations of mild to moderate chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2012 Oct 15;186(8):716-23. doi: 10.1164/rccm.201206-0996OC. Epub 2012 Aug 23.
PubMed 22923662
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Situations That do Not Require Antibiotics for Acute Exacerbations of Mild-to-moderate Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00495586
- Acronym / sponsor ID
- TRANCE / P06/31
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Antibiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)University, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria
- Study start
- Oct 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 3 Jul 2007 (estimated)
- Results
- Posted 13 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness of antibiotic therapy for patients with acute exacerbations of mild-to-moderate chronic obstructive pulmonary disease.
Detailed description
Antibiotics are usually prescribed for acute exacerbations of chronic obstructive pulmonary disease (COPD) even though their benefit in mild-to-moderate COPD is not demonstrated. The aim of this study is to assess the effectiveness of antibiotic therapy for exacerbations of COPD, what clinical variables are associated with an improved clinical response with antibiotic therapy with respect to placebo and to identify which patients might recover from an acute exacerbation without antibiotic therapy. Methodology: prospective, randomised, double blind, placebo-controlled clinical trial, in which exacerbations (at least one criterion present: increase of dyspnoea, increase of sputum production and/or increase of purulence) of patients older than 40 yr., smokers or ex-smokers of more than 10 pack-years, with COPD and FEV1 greater than 50%, diagnosed by spirometry and a predicted ratio FEV1/FVC<0.7%. Exclusion criteria: severe COPD (FEV1<50%), active neoplasm, tracheotomy, pneumonia, hospitalization criteria, patients previously being on antibiotics, immunodepressed, history of hypersensitivity to beta-lactams or intolerance to clavulanate, enrollment in other clinical trials, patients who refuse to take part in this study, and patients who have not had a spirometry test for the past two years. Sample size: 677 patients. Interventions: first visit: the patient will be given details of the clinical trial and will be asked to sign informed consent; other data: sputum color, chest X-ray ordered to rule out pneumonia, C-reactive protein levels, and peak flow measurement. The patient will be randomised to receive amoxicillin plus clavulanate or placebo and will be scheduled to return for a 2nd follow-up visit after 3 or 4 days to assess the clinical response and peak flow measurements and to rule out any worsening of the condition. Third visit: scheduled after 9-11 days to assess the clinical response, drug-compliance and peak flow measurement. Fourth visit after 15-20 days for clinical assessment and to observe whether any relapses have occurred. Date of the following exacerbation will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo pills t.i.d. for 8 days |
| Amoxycillin and clavulanic acid | Active comparator | Drug: Amoxicillin and clavulanic acidAmoxycillin and clavulanate t.i.d. for 8 days |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Acute exacerbations (at least one criterion present: increase of dyspnoea, increase of sputum production and/or increase of purulence) of
- patients older than 40 years old,
- smokers or ex-smokers of more than 10 pack-years,
- with COPD and FEV1 greater than 50%, diagnosed by spirometry and a predicted ratio FEV1/FVC<0.7%.
Key exclusion criteria (11 listed)
- Severe COPD (FEV1<50%)
- Pneumonia
- Active neoplasm
- Tracheotomy
- Criteria for hospitalisation
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 |
|---|---|---|
| PlaceboAlso: It's placeboOne pill to be taken every eight hours for 8 days | Drug | Placebo |
| Amoxicillin and clavulanic acidAlso: Augmentine 500-125 mg 24 pills500-125 mg to be taken every eight hours for 8 days | Drug | Amoxycillin and clavulanic acid |
Primary outcome
Number of Patients Who Were Cured
Time frame: Day 9-11
Cure defined as the disappearance of the acute signs and symptoms related to the infection, with complete return to the previous situation of stability
1 secondary outcome
Number of Days Till the Next Exacerbation
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23807094Miravitlles M, Moragas A, Hernandez S, Bayona C, Llor C. Is it possible to identify exacerbations of mild to moderate COPD that do not require antibiotic treatment? Chest. 2013 Nov;144(5):1571-1577. doi: 10.1378/chest.13-0518.
- Derived from this study: PubMed 22923662Llor C, Moragas A, Hernandez S, Bayona C, Miravitlles M. Efficacy of antibiotic therapy for acute exacerbations of mild to moderate chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2012 Oct 15;186(8):716-23. doi: 10.1164/rccm.201206-0996OC. Epub 2012 Aug 23.
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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.
Carl Llor, Doctor principal investigator
Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)
Marc Miravitlles, Doctor study director
Hospital Clinic
Ana Moragas, Family doc. study director
Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amoxicillin and clavulanic acid in people with Chronic Obstructive Pulmonary Disease, run by Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC) at 13 sites in Spain.
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 4 inclusion and 11 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 13 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Spain. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 13 Mar 2012). 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?
Number of Patients Who Were Cured (time frame: Day 9-11). 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 NCT00495586, which also lists 2 linked publications.
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 13 Mar 2012.