NCT03944928: TOUPIE

ThOracic Ultrasound in Idiopathic Pulmonary Fibrosis Evolution

Completed Last updated 5 October 2021

What this trial tests

trial testing Lung ultrasound in Idiopathic Pulmonary Fibrosis in 30 participants. Completed in 9 September 2021.

Timeline

11 June 2019

Primary endpoint
3 August 2020

9 September 2021

Quick facts

Lead sponsor	University Hospital, Tours
Status	Completed
Study type	OBSERVATIONAL
Enrollment	30
Start date	11 June 2019
Primary completion	3 August 2020
Estimated completion	9 September 2021
Sites	2 locations across France

Drugs / interventions tested

• Lung ultrasound

Conditions studied

• Idiopathic Pulmonary Fibrosis — all drugs for Idiopathic Pulmonary Fibrosis →

Sponsor

University Hospital, Tours

Who can join

18 and older, any sex, with Idiopathic Pulmonary Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Idiopathic pulmonary fibrosis (IPF) is one of the most common chronic idiopathic fibrotic interstitial lung disease (ILD). IPF is an evolving disease that requires regular follow-up through clinical examination, respiratory functional investigations and thoracic CT. Thoracic CT is necessary for the follow-up, usually performed yearly, and in case of deterioration of respiratory function. The disadvantages to its realization are the repeated irradiation, the cost, the accessibility, and sometimes the difficulties of realization related to the supine position.

Several signs of thoracic ultrasound have been described in ILD, including the number of B lines, the irregularity of the pleural line, and the thickening of the pleural line. Cross-sectional studies have correlated the intensity of these signs with the severity of fibrosis lesions on chest CT in patients with ILD, including IPF. However, no studies have prospectively described the evolution of ultrasound signs in the same IPF patient, or their correlation to clinical, functional and CT scan evolution.

The hypothesis is that thoracic ultrasound is a relevant tool to highlight the evolution of pulmonary lesions in IPF.

The main objective is to show with thoracic ultrasound an increase in one or more of the ultrasound signs: line B score, pleural line irregularity score, and pleural line thickness during the follow-up of patient with IPF.

The study will enroll patients with a validated diagnosis of IPF in a multidisciplinary staff. At each follow-up visit, patients will have a clinical examination, pulmonary functional test and thoracic ultrasound. The CT data collected will include the last thoracic CT performed in the 3 months before the inclusion and those performed during the patient's participation. The presence, location and severity of ultrasound signs, will be recorded for each patient during successive reassessments and correlation to clinical, functional and CT scan evolution will be made.

This study will add significant knowledge in the study of ultrasound signs evolution in patients with IPF. If there is a correlation with the clinical or CT scores, it will be possible to carry over the realization of the CTs to limit the irradiation of the patients. Conversely, early detection of worsening ultrasound signs may lead to faster therapeutic adjustments to limit the extent of irreversible fibrotic lesions.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. ThOracic Ultrasound in Idiopathic Pulmonary Fibrosis Evolution (TOUPIE): research protocol of a multicentric prospective study.
   Legué S, Marchand-Adam S, Plantier L, Bayeh BA, et al · · 2021 · cited 4× · PMID 33766834 · DOI 10.1136/bmjopen-2020-039078