NCT02594059

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 19, 2012

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 2, 2015

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2020

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

7.6 years

First QC Date

October 29, 2015

Last Update Submit

March 16, 2021

Conditions

Pulmonary Fibrosis

Keywords

endothelial function, idiopathic pulmonary fibrosis

Outcome Measures

Primary Outcomes (1)

  • measure of reactive hyperemia-peripheral artery tone index

    day 1

Secondary Outcomes (2)

  • endothelial function

    1, 2 and 3 years

  • measure of reactive hyperemia-peripheral artery tone index

    3 years

Study Arms (1)

Pulmonary idiopathic fibrosis

EXPERIMENTAL

Patients with pulmonary idiopathic fibrosis according to ATS/ERS 2011's criteria

Other: endothelial function

Interventions

endothelial functionOTHER

measure of reactive hyperemia-peripheral artery tone index

Pulmonary idiopathic fibrosis

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • IPF according to ATS/ERS 2011's criteria
  • Stable IPF (no reduction of FVC or DLCO of more than 10% and 15% respectively)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hopital Europeen Georges Pompidou, dpt of pneumology

Paris, 75015, France

Location

Hopital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Pulmonary FibrosisIdiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2015

First Posted

November 2, 2015

Study Start

December 19, 2012

Primary Completion

July 15, 2020

Study Completion

July 15, 2020

Last Updated

March 17, 2021

Record last verified: 2021-03

Locations

FR(2)