Chronic Obstructive Pulmonary DiseaseNCT02092675
Endothelial Dysfunction and Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease and Endothelial Dysfunction, run by Andrea Vukic Dugac at 1 site in Croatia.
Trial summary
The purpose of this study is to investigate the role of endothelial dysfunction in chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Endothelial Dysfunction
- How many people
- 117 participants
- Where
- 1 siteCroatia
- Study dates
- Mar 2013to May 2014
- Phase
- Observational
- 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 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient with COPD, smokers and former smokers recruited in an ambulatory basis.
Who may be able to join
- COPD patients in stable condition ( without exacerbation min 1 months ago)
- Over 40 years
- History of at least 10 py
Who cannot join
- acute exacerbation of COPD
- active malignancy
- autoimmune disease
- acute myocardial infarction
- diabetes mellitus with late complications
- congestive heart failure
- women of childbearing potential
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endothelial Dysfunction and Frequent Exacerbator Phenotype in Patient With Chronic Obstructive Pulmonary Disease
The purpose of this study is to investigate the role of endothelial dysfunction in chronic obstructive pulmonary disease.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is one of the leading causes of death in developed countries. Acute exacerbations and cardiovascular diseases are the major causes of morbidity and mortality in COPD patients. According to the frequency of exacerbations, phenotype "frequent exacerbator" is defined and characterised with severe clinical course and was recognised as an increased risk for cardiovascular mortality. Recent studies considered that systemic inflammation plays a key role in the pathogenesis of COPD and endothelial dysfunction is a suspected link between increased cardiovascular mortality and systemic inflammation in COPD patients. Endothelial dysfunction is assessed by determining flow mediated dilatation index (FMD index) or plasma markers. Previous studies have suggested the presence of endothelial dysfunction in COPD patients, as well as the deterioration of endothelial function during exacerbations of COPD. This study will, for the first time, systematically explore endothelial dysfunction in two phenotypically distinct groups of COPD patients with simultaneous assessment of endothelial function flow mediated dilatation index (FMD index) and plasma markers.
- Keywords
- Chronic obstructive pulmonary disease, frequent exacerbator, endothelial dysfunction, Flow mediated dilatation, Systemic inflammation
- 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.
| Study group | Role | What they receive |
|---|---|---|
| COPD patients - frequent exacerbator | COPD patients with 2 and more exacerbation in one year | |
| COPD patients - non frequent exacerbator | COPD patients with less than 2 exacerbation during one year | |
| control group - healthy smokers | healthy smokers, they do not have COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in endothelial dysfunction
Evidence of difference in endothelial dysfunction between COPD frequent exacerbator phenotype group and COPD non frequent exacerbator phenotype group
Measured: 6 months
Secondary outcomes (1)
difference in pulmonary functional tests
Difference in pulmonary functional test between COPD frequent exacerbator phenotype group and COPD non frequent exacerbator phenotype group
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startMar 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrea Vukic Dugac
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrea Vukic Dugac, Clinical Hospital Centre Zagreb
- Investigators
- Andrea Vukic Dugac, Principal investigator, University Hospital Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092675
- Sponsor's protocol ID
- ED-1971-HR
- Other IDs
- ED-1971-UHCZ
- Status last verified
- Dec 2014
- First submitted
- 17 Mar 2014
- Last updated
- 24 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Dysfunction and Frequent Exacerbator Phenotype in Patient With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02092675
- Acronym / sponsor ID
- ED-1971-HR
- Keywords
- Chronic obstructive pulmonary disease, frequent exacerbator, endothelial dysfunction, Flow mediated dilatation, Systemic inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Andrea Vukic DugacUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 20 Mar 2014 (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 this study is to investigate the role of endothelial dysfunction in chronic obstructive pulmonary disease.
Detailed description
Chronic obstructive pulmonary disease (COPD) is one of the leading causes of death in developed countries. Acute exacerbations and cardiovascular diseases are the major causes of morbidity and mortality in COPD patients. According to the frequency of exacerbations, phenotype "frequent exacerbator" is defined and characterised with severe clinical course and was recognised as an increased risk for cardiovascular mortality. Recent studies considered that systemic inflammation plays a key role in the pathogenesis of COPD and endothelial dysfunction is a suspected link between increased cardiovascular mortality and systemic inflammation in COPD patients. Endothelial dysfunction is assessed by determining flow mediated dilatation index (FMD index) or plasma markers. Previous studies have suggested the presence of endothelial dysfunction in COPD patients, as well as the deterioration of endothelial function during exacerbations of COPD. This study will, for the first time, systematically explore endothelial dysfunction in two phenotypically distinct groups of COPD patients with simultaneous assessment of endothelial function flow mediated dilatation index (FMD index) and plasma markers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COPD patients - frequent exacerbator | – | –COPD patients with 2 and more exacerbation in one year |
| COPD patients - non frequent exacerbator | – | –COPD patients with less than 2 exacerbation during one year |
| control group - healthy smokers | – | –healthy smokers, they do not have COPD |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with COPD, smokers and former smokers recruited in an ambulatory basis.
Key inclusion criteria (3 listed)
- COPD patients in stable condition ( without exacerbation min 1 months ago)
- Over 40 years
- History of at least 10 py
Key exclusion criteria (7 listed)
- acute exacerbation of COPD
- active malignancy
- autoimmune disease
- acute myocardial infarction
- diabetes mellitus with late complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
difference in endothelial dysfunction
Time frame: 6 months
Evidence of difference in endothelial dysfunction between COPD frequent exacerbator phenotype group and COPD non frequent exacerbator phenotype group
1 secondary outcome
difference in pulmonary functional tests
Time frame: 6 months
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 24 Dec 2014.
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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.
Andrea Vukic Dugac principal investigator
University Hospital Zagreb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Endothelial Dysfunction, run by Andrea Vukic Dugac at 1 site in Croatia.
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 3 inclusion and 7 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 24 Dec 2014. 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 Croatia. 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.
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?
difference in endothelial dysfunction (time frame: 6 months). 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 24 Dec 2014.