Chronic Obstructive Pulmonary DiseaseNCT03004352
Disturbed Blood Flow Induces Endothelial Dysfunction in Severe Chronic Obstructive Pulmonary Disease
A study testing retrograde flow and oxygen in people with Chronic Obstructive Pulmonary Disease, run by University of Split, School of Medicine.
Trial summary
The aim of the study is to determine if increased retrograde shear would further deteriorate the already impaired vascular function in severe COPD patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- retrograde flow and oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to May 2015
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- COPD
- chronic hypoxemia
Who cannot join
- an acute exacerbation, active respiratory infection or infection of other localisation 6 weeks prior to the visit
- relevant coexisting lung disease such as interstitial lung disease, cancer, renal failure, thromboembolic disease or major cardiovascular event during the previous year
- informed consent not provided or inability to comply with the study protocol
About this study
The aim of the study is to determine if increased retrograde shear would further deteriorate the already impaired vascular function in severe COPD patients.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- retrograde flow, oxygen
- 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.
retrograde flowOther
Two pneumatic cuffs were placed on the experimental arm, one on the lower forearm, and the other on the upper arm. Two cuffs were simultaneously inflated for 20 minutes. The distal cuff was inflated to 75 mm Hg and the proximal cuff was inflated to 40 mm Hg. The contralateral (control) arm was cuff free during this intervention.
oxygenOther
Supplemental 100% oxygen administered through a nasal cannula.
| Study group | Role | What they receive |
|---|---|---|
| control subjects-retrograde flow | Experimental | Retrograde flow was induced in control subjects. Receives: Other: retrograde flow |
| control subjects-control | No intervention | Not described |
| hypoxemic COPD-retrograde flow | Experimental | Retrograde flow was induced in hypoxemic COPD patients. Receives: Other: retrograde flow |
| hypoxemic COPD-control | No intervention | Not described |
| normoxemic COPD-retrograde flow with oxygen | Experimental | Retrograde flow was induced in COPD patients with normalized arterial oxygen saturation. Receives: Other: retrograde flow; Other: oxygen |
| normoxemic COPD-control with oxygen | Experimental | COPD patients with normalized arterial oxygen saturation. Receives: Other: oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Brachial Artery Diameter at 10, 20 and 25 minutes
Measured: 0,10, 20 and 25 minutes
Change from Baseline Microparticle Count at 20 minutes
Measured: 0 and 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startApr 2015
- Primary completionMay 2015
- Study completionMay 2015
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Split, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004352
- Sponsor's protocol ID
- ED-COPD
- Status last verified
- Dec 2016
- First submitted
- 20 Dec 2016
- Last updated
- 28 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disturbed Blood Flow Induces Endothelial Dysfunction in Severe Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03004352
- Acronym / sponsor ID
- ED-COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Split, School of MedicineUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 28 Dec 2016 (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 aim of the study is to determine if increased retrograde shear would further deteriorate the already impaired vascular function in severe COPD patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| control subjects-retrograde flow | Experimental | Other: retrograde flowRetrograde flow was induced in control subjects. |
| control subjects-control | No intervention | – |
| hypoxemic COPD-retrograde flow | Experimental | Other: retrograde flowRetrograde flow was induced in hypoxemic COPD patients. |
| hypoxemic COPD-control | No intervention | – |
| normoxemic COPD-retrograde flow with oxygen | Experimental | Other: retrograde flow, Other: oxygenRetrograde flow was induced in COPD patients with normalized arterial oxygen saturation. |
| normoxemic COPD-control with oxygen | Experimental | Other: oxygenCOPD patients with normalized arterial oxygen saturation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COPD
- chronic hypoxemia
Key exclusion criteria (3 listed)
- an acute exacerbation, active respiratory infection or infection of other localisation 6 weeks prior to the visit
- relevant coexisting lung disease such as interstitial lung disease, cancer, renal failure, thromboembolic disease or major cardiovascular event during the previous year
- informed consent not provided or inability to comply with the study protocol
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 |
|---|---|---|
| retrograde flowTwo pneumatic cuffs were placed on the experimental arm, one on the lower forearm, and the other on the upper arm. Two cuffs were simultaneously inflated for 20 minutes. The distal cuff was inflated to 75 mm Hg and the proximal cuff was inflated to 40 mm Hg. The contralateral (control) arm was cuff free during this intervention. | Other | control subjects-retrograde flow, hypoxemic COPD-retrograde flow, normoxemic COPD-retrograde flow with oxygen |
| oxygenSupplemental 100% oxygen administered through a nasal cannula. | Other | normoxemic COPD-control with oxygen, normoxemic COPD-retrograde flow with oxygen |
Primary outcome
Change from Baseline Brachial Artery Diameter at 10, 20 and 25 minutes
Time frame: 0,10, 20 and 25 minutes
Change from Baseline Microparticle Count at 20 minutes
Time frame: 0 and 20 minutes
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 28 Dec 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing retrograde flow and oxygen in people with Chronic Obstructive Pulmonary Disease, run by University of Split, School of Medicine.
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 2 inclusion and 3 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 28 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from Baseline Brachial Artery Diameter at 10, 20 and 25 minutes (time frame: 0,10, 20 and 25 minutes). 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?
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 28 Dec 2016.