Pulmonary Disease, Chronic ObstructivePhase 4NCT00132860
Prophylactic Antibiotic Treatment of Patients With Chronic Obstructive Lung Disease (COLD)
A Phase 4 study testing azithromycin in people with Pulmonary Disease, Chronic Obstructive, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The purpose of the study is to investigate, in patients with moderate to severe chronic obstructive lung disease, whether intermittent antibiotic treatment leads to: A slower rate of decline in forced expiratory volume in one second (FEV1); A reduction in the frequency and severity of exacerbations; Fewer hospital… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- azithromycin
- How many people
- 800 participants
- Where
- 1 siteDenmark
- Study dates
- May 2001to Dec 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients above 50 years of age, with a current admission for exacerbation of COLD or at least one admission within the previous two years.
- Current or ex-smoker
- Postbronchodilator FEV1 < 60% in stable condition (> 4 weeks after hospitalisation)
- < 300 ml bronchodilator reversibility in FEV1
Who cannot join
- Patients with end-stage COLD, who are not expected to survive for 3 years (typically bedridden patients being dyspnoeic in rest).
- Patients with known other respiratory tract infection, e.g. tuberculosis or aspergillosis, in whom the intervention is known to be inefficient.
- Patients with pulmonary malignancy
- Patients with other pulmonary diseases than COLD.
- Patients with immunodeficiency. However, COLD patients treated with steroids can be included.
- Patients with known hereditary disposition to lung infections such as alfa-1-antitrypsin deficiency, cystic fibrosis or primary ciliary dyskinesia.
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- Patients receiving longterm antibiotic treatment ( e.g. recurrent cystitis).
- Patients with known allergy or intolerance to azithromycin
- Pregnant or breastfeeding women
- Manifest heart, liver or renal insufficiency
- Patients that, for reasons not stated above, are unlikely to be able to participate in a study period of 3 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antibiotic Treatment of Patients With Chronic Obstructive Lung Disease: A Prospective, Randomized, Double-Blind Placebo-Controlled Study of Intermittent, Prophylactic Antibiotic Treatment With Azithromycin
The purpose of the study is to investigate, in patients with moderate to severe chronic obstructive lung disease, whether intermittent antibiotic treatment leads to:
- A slower rate of decline in forced expiratory volume in one second (FEV1);
- A reduction in the frequency and severity of exacerbations;
- Fewer hospital admissions for chronic obstructive pulmonary disease (COPD);
- Lower mortality;
- An improved quality of life as compared to a group of placebo treated patients.
Read the detailed description
Study Population: Patients with moderate to severe chronic obstructive lung disease.
Trial Phase: IV
Study Design: Prospective, randomised, double-blind, placebo- controlled clinical trial.
Study Medicine: Azithromycin.
Drug Administration: Oral.
Drug Dose: 500 mg once daily for 3 days every month.
Duration of Treatment: 3 years
Number of Evaluable Patients: 200 per treatment arm
Number of Included Patients: 400 per treatment arm, 800 patients in total.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- azithromycin
- 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.
azithromycinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
change in postbronchodilator FEV1
Secondary outcomes (7)
number of hospital admissions and number of hospital days
mortality
quality of life
use of medication
prevalence of respiratory pathogens
prevalence of macrolide resistance
inflammatory parameters
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 startMay 2001
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Single group
- Masking
- Double blind
- Enrolment
- 800 participants
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Svend S Pedersen, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132860
- Sponsor's protocol ID
- ProToCOL
- Status last verified
- Aug 2005
- First submitted
- 19 Aug 2005
- Last updated
- 19 Oct 2005
- Results posted
- No
Publications
Sorensen AK, Holmgaard DB, Mygind LH, Johansen J, Pedersen C. Neutrophil-to-lymphocyte ratio, calprotectin and YKL-40 in patients with chronic obstructive pulmonary disease: correlations and 5-year mortality - a cohort study. J Inflamm (Lond). 2015 Mar 18;12:20. doi: 10.1186/s12950-015-0064-5. eCollection 2015.
PubMed 25908927Holmgaard DB, Mygind LH, Titlestad IL, Madsen H, Pedersen SS, Johansen JS, Pedersen C. Plasma YKL-40 and all-cause mortality in patients with chronic obstructive pulmonary disease. BMC Pulm Med. 2013 Dec 30;13:77. doi: 10.1186/1471-2466-13-77.
PubMed 24373580
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Treatment of Patients With Chronic Obstructive Lung Disease: A Prospective, Randomized, Double-Blind Placebo-Controlled Study of Intermittent, Prophylactic Antibiotic Treatment With Azithromycin
- ClinicalTrials.gov ID
- NCT00132860
- Acronym / sponsor ID
- ProToCOL
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- May 2001
- Study completion
- Dec 2007
- 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.
The purpose of the study is to investigate, in patients with moderate to severe chronic obstructive lung disease, whether intermittent antibiotic treatment leads to:
- A slower rate of decline in forced expiratory volume in one second (FEV1);
- A reduction in the frequency and severity of exacerbations;
- Fewer hospital admissions for chronic obstructive pulmonary disease (COPD);
- Lower mortality;
- An improved quality of life as compared to a group of placebo treated patients.
Detailed description
Study Population: Patients with moderate to severe chronic obstructive lung disease.
Trial Phase: IV
Study Design: Prospective, randomised, double-blind, placebo- controlled clinical trial.
Study Medicine: Azithromycin.
Drug Administration: Oral.
Drug Dose: 500 mg once daily for 3 days every month.
Duration of Treatment: 3 years
Number of Evaluable Patients: 200 per treatment arm
Number of Included Patients: 400 per treatment arm, 800 patients in total.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients above 50 years of age, with a current admission for exacerbation of COLD or at least one admission within the previous two years.
- Current or ex-smoker
- Postbronchodilator FEV1 < 60% in stable condition (> 4 weeks after hospitalisation)
- < 300 ml bronchodilator reversibility in FEV1
Key exclusion criteria (11 listed)
- Patients with end-stage COLD, who are not expected to survive for 3 years (typically bedridden patients being dyspnoeic in rest).
- Patients with known other respiratory tract infection, e.g. tuberculosis or aspergillosis, in whom the intervention is known to be inefficient.
- Patients with pulmonary malignancy
- Patients with other pulmonary diseases than COLD.
- Patients with immunodeficiency. However, COLD patients treated with steroids can be included.
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 | – |
Primary outcome
change in postbronchodilator FEV1
7 secondary outcomes
number of hospital admissions and number of hospital days
mortality
quality of life
use of medication
prevalence of respiratory pathogens
prevalence of macrolide resistance
inflammatory parameters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2005.
- Derived from this study: PubMed 25908927Sorensen AK, Holmgaard DB, Mygind LH, Johansen J, Pedersen C. Neutrophil-to-lymphocyte ratio, calprotectin and YKL-40 in patients with chronic obstructive pulmonary disease: correlations and 5-year mortality - a cohort study. J Inflamm (Lond). 2015 Mar 18;12:20. doi: 10.1186/s12950-015-0064-5. eCollection 2015.
- Derived from this study: PubMed 24373580Holmgaard DB, Mygind LH, Titlestad IL, Madsen H, Pedersen SS, Johansen JS, Pedersen C. Plasma YKL-40 and all-cause mortality in patients with chronic obstructive pulmonary disease. BMC Pulm Med. 2013 Dec 30;13:77. doi: 10.1186/1471-2466-13-77.
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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.
Svend S Pedersen principal investigator
Odense University Hospital
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 azithromycin in people with Pulmonary Disease, Chronic Obstructive, run by Odense University Hospital at 1 site in Denmark.
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: status not confirmed, as of the sponsor's last update on 19 Oct 2005. 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 Denmark. 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?
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?
change in postbronchodilator FEV1. 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 NCT00132860, 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 19 Oct 2005.