Clinical trial NCT03898284: Impulse Oscillometry for Prognostication in Idiopathic Pulmonary Fibrosis
Official title: Impulse Oscillometry for Prognostication in Idiopathic Pulmonary Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Idiopathic Pulmonary Fibrosis
Impulse Oscillometry
Forced Vital Capacity
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 54
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Idiopathic Pulmonary Fibrosis

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.

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.

Eligibility 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.

Primary outcomes:
measure: Performance of the 5-Hz reactance of the respiratory system (Xsr5) variation at 3 months, for the diagnosis of rapid decline in lung function.
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Performance of the 3-month variation in additional impulse oscillometry parameters for the diagnosis of rapid decline in lung function
timeFrame: Baseline, 3 months, 6 months
measure: Performance of baseline impulse oscillometry parameters for the diagnosis of rapid decline in lung function
timeFrame: Baseline, 3 months, 6 months
measure: Assess correlations between impulse oscillometry parameters and forced vital capacity
timeFrame: Baseline, 3 months, 6 months
measure: Assess correlations between impulse oscillometry parameters and exertional dyspnea
timeFrame: Baseline, 3 months, 6 months
measure: Assess correlations between impulse oscillometry parameters and the extent of either fibrosis or emphysema lesions on CT scans
timeFrame: Baseline
Other outcomes:
Locations:
city: Lille
country: France
facility: Respiratory Functional Explorations, University Hospital, Lille
city: Nantes
country: France
facility: Respiratory Functional Explorations, University Hospital, Nantes
city: Rouen
country: France
facility: Department of digestive physiology, urinary, respiratory and exercise, University Hospital, Rouen
city: Tours
country: France
facility: Pulmonology Department, University Hospital, Tours
Study officials:
affiliation: University Hospital, Tours
name: Laurent PLANTIER, MD-PhD
role: STUDY_DIRECTOR
References: