Pulmonary FibrosisEndoth-FPINCT02594059
Assessment of Peripheral Endothelial Function in Idiopathic Pulmonary Fibrosis
A study testing endothelial function in people with Pulmonary Fibrosis, run by Hopital Foch at 2 sites in France.
Trial summary
The aim of the study is to assess the peripheral endothelial function in adult patients with idiopathic pulmonary fibrosis (IPF) and the relationship between the peripheral endothelial function and the severity of the IPF. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pulmonary Fibrosis
- What is being tested?
- endothelial function
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesFrance
- Study dates
- 19 Dec 2012to 15 Jul 2020
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IPF according to ATS/ERS 2011's criteria
- Stable IPF (no reduction of FVC or DLCO of more than 10% and 15% respectively)
Who cannot join
- Patients with a significant disease other than IPF. A significant disease is defined as a disease which, in the opinion of the investigator, may influence the results of the trial.
- Pregnant or nursing women.
- Non-pulmonary fibrosis
- treatment by pulmonary vasodilators that cannot be stopped for 24 hours for the assessment of endothelial function
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hopital Europeen Georges Pompidou, dpt of pneumology
Paris, 75015
Hopital Foch
Suresnes, 92150
About this study
The aim of the study is to assess the peripheral endothelial function in adult patients with idiopathic pulmonary fibrosis (IPF) and the relationship between the peripheral endothelial function and the severity of the IPF.
Read the detailed description
The primary criteria is the peripheral endothelial function that will be assessed by the measure of flow-mediated dilation (reactive hyperemia-peripheral artery tone index). The pulmonary function will be assessed by the measures of the forced expiratory volume at one second (FEV1), the forced vital capacity (FVC) and the total lung capacity (TLC) and the diffusing capacity of the lung for carbon monoxide (DLCO). The dyspnea will be assessed with the New York Heart Association (NYHA) score. The exercise capacity will be assessed by the 6-min walk test. Pulmonary arterial pressure will be recorded through cardiac echography or catheterization.
- Conditions
- Pulmonary Fibrosis
- Being tested
- endothelial function
- Keywords
- endothelial function, idiopathic pulmonary fibrosis
- Medical subject headings
- Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endothelial functionOther
measure of reactive hyperemia-peripheral artery tone index
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary idiopathic fibrosis | Experimental | Patients with pulmonary idiopathic fibrosis according to ATS/ERS 2011's criteria Receives: Other: endothelial function |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure of reactive hyperemia-peripheral artery tone index
Measured: day 1
Secondary outcomes (2)
endothelial function
measure of reactive hyperemia-peripheral artery tone index
Measured: 1, 2 and 3 years
measure of reactive hyperemia-peripheral artery tone index
measure of reactive hyperemia-peripheral artery tone index at IPF exacerbation or PAHT's occurence
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study start19 Dec 2012
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594059
- Sponsor's protocol ID
- 2012/56
- Acronym
- Endoth-FPI
- Status last verified
- Mar 2021
- First submitted
- 29 Oct 2015
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Peripheral Endothelial Function in Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT02594059
- Acronym / sponsor ID
- Endoth-FPI / 2012/56
- Conditions
- Pulmonary Fibrosis
- Keywords
- endothelial function, idiopathic pulmonary fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 19 Dec 2012 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 2 Nov 2015 (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 assess the peripheral endothelial function in adult patients with idiopathic pulmonary fibrosis (IPF) and the relationship between the peripheral endothelial function and the severity of the IPF.
Detailed description
The primary criteria is the peripheral endothelial function that will be assessed by the measure of flow-mediated dilation (reactive hyperemia-peripheral artery tone index). The pulmonary function will be assessed by the measures of the forced expiratory volume at one second (FEV1), the forced vital capacity (FVC) and the total lung capacity (TLC) and the diffusing capacity of the lung for carbon monoxide (DLCO). The dyspnea will be assessed with the New York Heart Association (NYHA) score. The exercise capacity will be assessed by the 6-min walk test. Pulmonary arterial pressure will be recorded through cardiac echography or catheterization.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary idiopathic fibrosis | Experimental | Other: endothelial functionPatients with pulmonary idiopathic fibrosis according to ATS/ERS 2011's criteria |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- IPF according to ATS/ERS 2011's criteria
- Stable IPF (no reduction of FVC or DLCO of more than 10% and 15% respectively)
Key exclusion criteria (4 listed)
- Patients with a significant disease other than IPF. A significant disease is defined as a disease which, in the opinion of the investigator, may influence the results of the trial.
- Pregnant or nursing women.
- Non-pulmonary fibrosis
- treatment by pulmonary vasodilators that cannot be stopped for 24 hours for the assessment of endothelial function
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 |
|---|---|---|
| endothelial functionmeasure of reactive hyperemia-peripheral artery tone index | Other | Pulmonary idiopathic fibrosis |
Primary outcome
measure of reactive hyperemia-peripheral artery tone index
Time frame: day 1
2 secondary outcomes
endothelial function
Time frame: 1, 2 and 3 years
measure of reactive hyperemia-peripheral artery tone index
Time frame: 3 years
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 17 Mar 2021.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endothelial function in people with Pulmonary Fibrosis, run by Hopital Foch at 2 sites in France.
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 4 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 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
measure of reactive hyperemia-peripheral artery tone index (time frame: day 1). 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 17 Mar 2021.