COPDPhase 2NCT00323986
Azithromycin Treatment of Patients With Chronic Obstructive Pulmonary Disease (COPD) and Tracheostomy
A Phase 2 study testing azithromycin (drug) in people with COPD and Tracheostomy, run by University of Milan at 3 sites in Italy.
Trial summary
Aims of the study to evaluate the rate of enteric gram negative bacteria colonization in tracheotomised COPD patients to evaluate the effect of azithromycin long-term treatment on Pseudomonas aeruginosa colonization and colony counts, and on reduction of the number of exacerbations/hospitalisations, antibiotic courses… Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- COPD, Tracheostomy
- What is being tested?
- azithromycin (drug)
- How many people
- 30 participants
- Where
- 3 sitesItaly
- Study dates
- Oct 2004to Apr 2006
- Phase
- Phase 2
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 45 years Tracheotomy History of COPD demonstrated by pulmonary function tests Informed Consent
Who cannot join
- Allergy to macrolides Life expectancy < 1 year
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Istituto Nazionale di riposo e cura per anziani (INRCA)
Casatenovo, 23880
Istituto Malattie Respiratorie University of Milan
Milan, 20122
University Hospital Trieste
Trieste, 34100
About this study
Official title: Azithromycin Treatment of Patients With Chronic Obstructive Pulmonary Disease (COPD) and Tracheostomy. Effects on Recurrent Respiratory Infections, Inflammatory Parameters and Bacterial Persistence
Aims of the study
- to evaluate the rate of enteric gram negative bacteria colonization in tracheotomised COPD patients
- to evaluate the effect of azithromycin long-term treatment on Pseudomonas aeruginosa colonization and colony counts, and on reduction of the number of exacerbations/hospitalisations, antibiotic courses and steroid use.
- to evaluate the Quality of Life of patients treated and not treated with azithromycin, using a validate Italian version of St George questionnaire
- to evaluate the rate of chronic colonization with atypical pathogens
- to evaluate the safety and tolerability of a long-term treatment with azithromycin, including a survey on possible bacterial antibiotic resistance pattern variations
Read the detailed description
Methods. Study Design Prospective, randomised, multicentre study. Centers
- Dott. E. Guffanti, IRCCS INRCA Casatenovo, Varese Italy
- Prof. F. Blasi, Università degli Studi di Milano, IRCCS Ospedale Maggiore Milan Italy
- Dott, M. Confalonieri, Ospedale Trieste, Italy Patients
We plan to enrol 30 patients :
Inclusion criteria
- Age > 45 years
- Tracheotomy
- History of COPD demonstrated by pulmonary function tests
- Informed Consent Exclusion criteria
- Allergy to macrolides
- Life expectancy < 1 year
Exhaled breath condensate (EBC) The breath condensate samples is collected using a specially designed condensing chamber (Ecoscreen; Jaeger, Hoechberg, Germany). The exhaled air entered and left the chamber though one-way inlet and outlet valves, thus keeping the chamber closed. The subjects wear noseclips and breathed tidally through a mouthpiece connected to the condenser for ten minutes. Approximately 1 ml of the sampled material is transferred to 2-ml plastic tube and stored at -70°C.
Interleukin-6 assay Interleukin-6 concentrations in the breath condensate will be measured using a specific enzyme immunoassay kit (EIA) (Cayman Chemical, Ann Arbor, USA). The assay is directly validated by means of gas chromatography/mass spectrometry in order to obtain a high correlation (r=0.95) between known amounts of IL-6 and the concentration measured by the EIA. The detection limit of the assay was 1.5 pg/ml after a two-hour development period.
TNF alfa TNF-alfa serum levels will be measured by enzyme immunoassay (Cayman Chemical, Ann Arbor, USA)
Microbiology Quantitative culture of tracheal aspirate will be performed at steady state, every 3 months and at exacerbation. Molecular biology techniques for Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Chlamydia pneumoniae and Mycoplasma pneumoniae identification will be also applied on the same specimens.
Timetable Enrolment: between January 2004 and December 2005 Visits : Every 3 months and on each exacerbation/hospitalization a visit will be performed. Every month a phone call will be performed.
Follow-up: 12 months. End of the study : July 2006
Visit
- Visit 1. A complete history will be recorded. Inclusion and exclusion criteria will be checked. Informed consent will be collected and QoL questionnaire completed. Tracheal aspirate will be performed and divided into two aliquots : one for the local microbiology lab for quantitative cultures, and one for central lab for bacterial detection by PCR (stored at -80°C). Exhaled breath samples will be obtained.
- Follow-up visits. Every 3 months the patients will be recalled at the center and all Visit 1 procedures will be repeated. Number of exacerbations/hospitalisation will be recorded and QoL questionnaire completed.
- Exacerbation/hospitalisation visit. In presence of symptoms deterioration patients will be instructed to contact the center for a visit. All Visit 1 procedures will be repeated.
- End of the study visit. At the end of the 12 month follow-up all Visit 1 procedures will be repeated. Number of exacerbations/hospitalisation will be recorded and QoL questionnaire completed.
Treatment Patients will be randomised to receive usual care or usual care + Azithromycin 500 mg o.d. three day-a-week (Monday, Tuesday, Wednesday) for 6 months.
Outcome measures
- reduction of inflammatory cytokines in EBC
- reduction of colony counts/eradication of bacteria on bronchial aspirates
- reduction of number of exacerbations/hospitalisations
- reduction of steroids and antibiotics use
- Quality of life
- Conditions
- COPD, Tracheostomy
- Being tested
- azithromycin (drug)
- Keywords
- COPD, tracheotomy, azithromycin, exacerbation, hospitalisation, exhaled breath condensate
- 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.
azithromycin (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of number of exacerbations
reduction of number of hospitalisations
Secondary outcomes (3)
reduction of colony counts/eradication of bacteria on bronchial aspirates
reduction of steroids and antibiotics use
reduction of inflammatory cytokines in EBC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2006 (estimated)
- Study startOct 2004
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Francesco Blasi, MD, Principal investigator, Istituto Malattie Respiratorie University of Milan Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00323986
- Sponsor's protocol ID
- 39/2004
- Status last verified
- Apr 2006
- First submitted
- 8 May 2006
- Last updated
- 10 May 2006
- Results posted
- No
Publications
Blasi F, Bonardi D, Aliberti S, Tarsia P, Confalonieri M, Amir O, Carone M, Di Marco F, Centanni S, Guffanti E. Long-term azithromycin use in patients with chronic obstructive pulmonary disease and tracheostomy. Pulm Pharmacol Ther. 2010 Jun;23(3):200-7. doi: 10.1016/j.pupt.2009.12.002. Epub 2009 Dec 16.
PubMed 20025989
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azithromycin Treatment of Patients With Chronic Obstructive Pulmonary Disease (COPD) and Tracheostomy. Effects on Recurrent Respiratory Infections, Inflammatory Parameters and Bacterial Persistence
- ClinicalTrials.gov ID
- NCT00323986
- Acronym / sponsor ID
- 39/2004
- Conditions
- COPD, Tracheostomy
- Keywords
- COPD, tracheotomy, azithromycin, exacerbation, hospitalisation, exhaled breath condensate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants
- Lead sponsor
- University of MilanUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Oct 2004
- Study completion
- Apr 2006
- First posted
- 10 May 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.
Aims of the study
- to evaluate the rate of enteric gram negative bacteria colonization in tracheotomised COPD patients
- to evaluate the effect of azithromycin long-term treatment on Pseudomonas aeruginosa colonization and colony counts, and on reduction of the number of exacerbations/hospitalisations, antibiotic courses and steroid use.
- to evaluate the Quality of Life of patients treated and not treated with azithromycin, using a validate Italian version of St George questionnaire
- to evaluate the rate of chronic colonization with atypical pathogens
- to evaluate the safety and tolerability of a long-term treatment with azithromycin, including a survey on possible bacterial antibiotic resistance pattern variations
Detailed description
Methods. Study Design Prospective, randomised, multicentre study. Centers
- Dott. E. Guffanti, IRCCS INRCA Casatenovo, Varese Italy
- Prof. F. Blasi, Università degli Studi di Milano, IRCCS Ospedale Maggiore Milan Italy
- Dott, M. Confalonieri, Ospedale Trieste, Italy Patients
We plan to enrol 30 patients :
Inclusion criteria
- Age > 45 years
- Tracheotomy
- History of COPD demonstrated by pulmonary function tests
- Informed Consent Exclusion criteria
- Allergy to macrolides
- Life expectancy < 1 year
Exhaled breath condensate (EBC) The breath condensate samples is collected using a specially designed condensing chamber (Ecoscreen; Jaeger, Hoechberg, Germany). The exhaled air entered and left the chamber though one-way inlet and outlet valves, thus keeping the chamber closed. The subjects wear noseclips and breathed tidally through a mouthpiece connected to the condenser for ten minutes. Approximately 1 ml of the sampled material is transferred to 2-ml plastic tube and stored at -70°C.
Interleukin-6 assay Interleukin-6 concentrations in the breath condensate will be measured using a specific enzyme immunoassay kit (EIA) (Cayman Chemical, Ann Arbor, USA). The assay is directly validated by means of gas chromatography/mass spectrometry in order to obtain a high correlation (r=0.95) between known amounts of IL-6 and the concentration measured by the EIA. The detection limit of the assay was 1.5 pg/ml after a two-hour development period.
TNF alfa TNF-alfa serum levels will be measured by enzyme immunoassay (Cayman Chemical, Ann Arbor, USA)
Microbiology Quantitative culture of tracheal aspirate will be performed at steady state, every 3 months and at exacerbation. Molecular biology techniques for Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Chlamydia pneumoniae and Mycoplasma pneumoniae identification will be also applied on the same specimens.
Timetable Enrolment: between January 2004 and December 2005 Visits : Every 3 months and on each exacerbation/hospitalization a visit will be performed. Every month a phone call will be performed.
Follow-up: 12 months. End of the study : July 2006
Visit
- Visit 1. A complete history will be recorded. Inclusion and exclusion criteria will be checked. Informed consent will be collected and QoL questionnaire completed. Tracheal aspirate will be performed and divided into two aliquots : one for the local microbiology lab for quantitative cultures, and one for central lab for bacterial detection by PCR (stored at -80°C). Exhaled breath samples will be obtained.
- Follow-up visits. Every 3 months the patients will be recalled at the center and all Visit 1 procedures will be repeated. Number of exacerbations/hospitalisation will be recorded and QoL questionnaire completed.
- Exacerbation/hospitalisation visit. In presence of symptoms deterioration patients will be instructed to contact the center for a visit. All Visit 1 procedures will be repeated.
- End of the study visit. At the end of the 12 month follow-up all Visit 1 procedures will be repeated. Number of exacerbations/hospitalisation will be recorded and QoL questionnaire completed.
Treatment Patients will be randomised to receive usual care or usual care + Azithromycin 500 mg o.d. three day-a-week (Monday, Tuesday, Wednesday) for 6 months.
Outcome measures
- reduction of inflammatory cytokines in EBC
- reduction of colony counts/eradication of bacteria on bronchial aspirates
- reduction of number of exacerbations/hospitalisations
- reduction of steroids and antibiotics use
- Quality of life
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age > 45 years Tracheotomy History of COPD demonstrated by pulmonary function tests Informed Consent
Key exclusion criteria (1 listed)
- Allergy to macrolides Life expectancy < 1 year
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 |
|---|---|---|
| azithromycin (drug) | Drug | – |
Primary outcome
reduction of number of exacerbations
reduction of number of hospitalisations
3 secondary outcomes
reduction of colony counts/eradication of bacteria on bronchial aspirates
reduction of steroids and antibiotics use
reduction of inflammatory cytokines in EBC
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 10 May 2006.
- Derived from this study: PubMed 20025989Blasi F, Bonardi D, Aliberti S, Tarsia P, Confalonieri M, Amir O, Carone M, Di Marco F, Centanni S, Guffanti E. Long-term azithromycin use in patients with chronic obstructive pulmonary disease and tracheostomy. Pulm Pharmacol Ther. 2010 Jun;23(3):200-7. doi: 10.1016/j.pupt.2009.12.002. Epub 2009 Dec 16.
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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.
Francesco Blasi, MD principal investigator
Istituto Malattie Respiratorie University of Milan Italy
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing azithromycin (drug) in people with COPD and Tracheostomy, run by University of Milan at 3 sites in Italy.
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: stopped early, as of the sponsor's last update on 10 May 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
reduction of number of exacerbations. The study lists 2 primary outcomes in all. 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 NCT00323986, which also lists 1 linked publication.
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 10 May 2006.