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Impulse Oscillometry for Prognostication in Idiopathic Pulmonary Fibrosis

NCT ID: NCT03898284

Last Updated: 2021-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-23

Study Completion Date

2021-09-27

Brief Summary

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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.

Detailed Description

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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

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Idiopathic Pulmonary Fibrosis

Keywords

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Idiopathic Pulmonary Fibrosis Impulse Oscillometry Forced Vital Capacity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Impulse Oscillometry

Intervention Type DIAGNOSTIC_TEST

Impulse Oscillometry will be performed in addition to usual care

Interventions

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Impulse Oscillometry

Impulse Oscillometry will be performed in addition to usual care

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurent PLANTIER, MD-PhD

Role: STUDY_DIRECTOR

University Hospital, Tours

Locations

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Respiratory Functional Explorations, University Hospital, Lille

Lille, , France

Site Status

Respiratory Functional Explorations, University Hospital, Nantes

Nantes, , France

Site Status

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

Rouen, , France

Site Status

Pulmonology Department, University Hospital, Tours

Tours, , France

Site Status

Countries

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France

Other Identifiers

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2018-A02300-55

Identifier Type: OTHER

Identifier Source: secondary_id

RIPH3-RNI18/OSCILLO

Identifier Type: -

Identifier Source: org_study_id