Impulse Oscillometry for Prognostication in Idiopathic Pulmonary Fibrosis (OSCILLO)

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Diagnostic test: Impulse Oscillometry

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • Respiratory Functional Explorations, University Hospital, Lille
  • Nantes, France, 44093
    • Respiratory Functional Explorations, University Hospital, Nantes
  • Rouen, France
    • Department of digestive physiology, urinary, respiratory and exercise, University Hospital, Rouen
  • Tours, France, 37044
    • Pulmonology Department, University Hospital, Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Idiopathic Pulmonary Fibrosis

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).
• History of lower respiratory infection or acute respiratory failure of any cause less than 90 days before inclusion.
• Opposition to data processing.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Impulse Oscillometry will be performed in addition to usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of the 3-month variation in additional impulse oscillometry parameters 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
Performance of baseline impulse oscillometry parameters 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
Assess correlations between impulse oscillometry parameters and forced vital capacity	Forced vital capacity is the total amount of air exhaled during the Forced expiratory volume test (how much air a person can exhale during a forced breath)	Baseline, 3 months, 6 months
Assess correlations between impulse oscillometry parameters and exertional dyspnea	Dyspnea is assessed by the baseline dyspnea questionnaire and the transitional dyspnea questionnaire	Baseline, 3 months, 6 months
Assess correlations between impulse oscillometry parameters and the extent of either fibrosis or emphysema lesions on CT scans	Lesions are scored by trained observers.	Baseline

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Study Director: Laurent PLANTIER, MD-PhD, University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2019
• Primary Completion (Actual): September 27, 2021
• Study Completion (Actual): September 27, 2021

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: March 29, 2019
• First Posted (Actual): April 1, 2019

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 10, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Idiopathic Pulmonary Fibrosis; Impulse Oscillometry; Forced Vital Capacity
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: RIPH3-RNI18/OSCILLO; 2018-A02300-55 (Other Identifier: IdRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No