Impulse Oscillometry for Prognostication in Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Clinical Trial

— OSCILLO  

Official title:

Impulse Oscillometry for Prognostication in Idiopathic Pulmonary Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03898284
• Other study ID #: RIPH3-RNI18/OSCILLO
• Secondary ID: 2018-A02300-55
• Status: Completed
• Start date: April 23, 2019
• Est. completion date: September 27, 2021

Study information

• Verified date: November 2021
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 27, 2021
• Est. primary completion date: September 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Diagnostic Test:
• Impulse Oscillometry
Impulse Oscillometry will be performed in addition to usual care

Locations

Country	Name	City	State
France	Respiratory Functional Explorations, University Hospital, Lille	Lille
France	Respiratory Functional Explorations, University Hospital, Nantes	Nantes
France	Department of digestive physiology, urinary, respiratory and exercise, University Hospital, Rouen	Rouen
France	Pulmonology Department, University Hospital, Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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