Impulse Oscillometry for Prognostication in Idiopathic Pulmonary Fibrosis

NCT03898284 | Completed

• 2 other identifiers: RIPH3-RNI18/OSCILLO2018-A02300-55
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 4

Brief Summary

A 5-point decline of forced vital capacity expressed as % predicted, over 6 months, is the current definition of disease progression (fast decline in lung function) in idiopathic pulmonary fibrosis. There is a need for techniques allowing to characterize disease progression earlier, so that treatment may be adapted as early as possible in the lack of a response. Hypothesis. Our hypothesis is that 3-month changes of lung function parameters measured by a novel technique, impulse oscillometry, predicts 6-month changes in forced vital capacity in idiopathic pulmonary fibrosis.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary Fibrosis; Impulse Oscillometry; Forced Vital Capacity

Outcome Measures

Primary Outcomes (1)

• Performance of the 5-Hz reactance of the respiratory system (Xsr5) variation at 3 months, for the diagnosis of rapid decline in lung function.

  Receiver operating characteristics curves will be used to determine diagnostic performance.

  Baseline, 3 months, 6 months

Secondary Outcomes (5)

• Performance of the 3-month variation in additional impulse oscillometry parameters for the diagnosis of rapid decline in lung function

  Baseline, 3 months, 6 months

• Performance of baseline impulse oscillometry parameters for the diagnosis of rapid decline in lung function

  Baseline, 3 months, 6 months

• Assess correlations between impulse oscillometry parameters and forced vital capacity

  Baseline, 3 months, 6 months

• Assess correlations between impulse oscillometry parameters and exertional dyspnea

  Baseline, 3 months, 6 months

• Assess correlations between impulse oscillometry parameters and the extent of either fibrosis or emphysema lesions on CT scans

  Baseline

Study Arms (1)

Impulse Oscillometry

Patients with Idiopathic Pulmonary Fibrosis. The objective is to determine whether another lung function technique, impulse oscillometry, is of interest to identify disease progression before changes in forced vital capacity can be ascertained.

Diagnostic Test: Impulse Oscillometry

Interventions

Impulse Oscillometry DIAGNOSTIC_TEST

Impulse Oscillometry will be performed in addition to usual care

Impulse Oscillometry

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Idiopathic Pulmonary Fibrosis

You may qualify if:

• Age ≥ 45 years.
• Idiopathic Pulmonary Fibrosis defined Interstitial Lung Diseases with 1) lack of any known cause for Interstitial Lung Diseases and 2) either the "definite usual interstitial pneumonia" pattern at CT scan, or the usual interstitial pneumonia (definite, probable or possible) pattern at lung biopsy, according to the Lung Function Group of the French Pulmonology Society criteria.

You may not qualify if:

• History of chronic obstructive airway disease.
• History of congestive heart failure.
• Emphysema-fibrosis syndrome, defined as emphysematous lesions involving \>15% of the lung area at the level of the aortic arch (upper lobes).
• Opposition to data processing.

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (4)

Respiratory Functional Explorations, University Hospital, Lille

Lille, 59037, France

Location

Respiratory Functional Explorations, University Hospital, Nantes

Nantes, 44093, France

Location

Department of digestive physiology, urinary, respiratory and exercise, University Hospital, Rouen

Rouen, France

Location

Pulmonology Department, University Hospital, Tours

Tours, 37044, France

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Laurent PLANTIER, MD-PhD

  University Hospital, Tours

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: April 1, 2019
• Study Start: April 23, 2019
• Primary Completion: September 27, 2021
• Study Completion: September 27, 2021
• Last Updated: November 11, 2021

Record last verified: 2021-11

Locations

FR (4)