Impulse Oscillometry for Prognostication in Idiopathic Pulmonary Fibrosis (OSCILLO)

• ClinicalTrials.gov Identifier: NCT03898284
• Recruitment Status: Completed
• First Posted: April 1, 2019
• Last Update Posted: November 11, 2021
• Sponsor: University Hospital, Tours
• Information provided by (Responsible Party): University Hospital, Tours

Study Description

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.

Condition or disease	Intervention/treatment
Idiopathic Pulmonary Fibrosis	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 Design

• Study Type: Observational
• Actual Enrollment: 54 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Impulse Oscillometry for Prognostication in Idiopathic Pulmonary Fibrosis
• Actual Study Start Date: April 23, 2019
• Actual Primary Completion Date: September 27, 2021
• Actual Study Completion Date: September 27, 2021

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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. [ Time Frame: Baseline, 3 months, 6 months ]
   Receiver operating characteristics curves will be used to determine diagnostic performance.

Secondary Outcome Measures :

1. Performance of the 3-month variation in additional impulse oscillometry parameters for the diagnosis of rapid decline in lung function [ Time Frame: Baseline, 3 months, 6 months ]
   Receiver operating characteristics curves will be used to determine diagnostic performance.
2. Performance of baseline impulse oscillometry parameters for the diagnosis of rapid decline in lung function [ Time Frame: Baseline, 3 months, 6 months ]
   Receiver operating characteristics curves will be used to determine diagnostic performance.
3. Assess correlations between impulse oscillometry parameters and forced vital capacity [ Time Frame: Baseline, 3 months, 6 months ]
   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)
4. Assess correlations between impulse oscillometry parameters and exertional dyspnea [ Time Frame: Baseline, 3 months, 6 months ]
   Dyspnea is assessed by the baseline dyspnea questionnaire and the transitional dyspnea questionnaire
5. Assess correlations between impulse oscillometry parameters and the extent of either fibrosis or emphysema lesions on CT scans [ Time Frame: Baseline ]
   Lesions are scored by trained observers.

Eligibility Criteria

• Ages Eligible for Study: 45 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients with Idiopathic Pulmonary Fibrosis

Criteria

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.

Contacts and Locations

Locations

France

Respiratory Functional Explorations, University Hospital, Lille

Lille, France, 59037

Respiratory Functional Explorations, University Hospital, Nantes

Nantes, France, 44093

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

Rouen, France

Pulmonology Department, University Hospital, Tours

Tours, France, 37044

Sponsors and Collaborators

University Hospital, Tours

Investigators

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

More Information

• Responsible Party: University Hospital, Tours
• ClinicalTrials.gov Identifier: NCT03898284
• Other Study ID Numbers: RIPH3-RNI18/OSCILLO; 2018-A02300-55 ( Other Identifier: IdRCB )
• First Posted: April 1, 2019
• Last Update Posted: November 11, 2021
• Last Verified: November 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Tours:

Idiopathic Pulmonary Fibrosis; Impulse Oscillometry; Forced Vital Capacity

Additional relevant MeSH terms:

Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis; Pathologic Processes; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases