Idiopathic Pulmonary Fibrosis
Conditions
Keywords
Idiopathic Pulmonary Fibrosis, Impulse Oscillometry, Forced Vital Capacity
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.
Interventions
DIAGNOSTIC_TESTImpulse Oscillometry
Impulse Oscillometry will be performed in addition to usual care
Sponsors
University Hospital, Tours
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance of the 5-Hz reactance of the respiratory system (Xsr5) variation at 3 months, for the diagnosis of rapid decline in lung function. | Baseline, 3 months, 6 months | Receiver operating characteristics curves will be used to determine diagnostic performance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance of the 3-month variation in additional impulse oscillometry parameters for the diagnosis of rapid decline in lung function | Baseline, 3 months, 6 months | Receiver operating characteristics curves will be used to determine diagnostic performance. |
| Performance of baseline impulse oscillometry parameters for the diagnosis of rapid decline in lung function | Baseline, 3 months, 6 months | Receiver operating characteristics curves will be used to determine diagnostic performance. |
| Assess correlations between impulse oscillometry parameters and forced vital capacity | 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) |
| Assess correlations between impulse oscillometry parameters and exertional dyspnea | Baseline, 3 months, 6 months | Dyspnea is assessed by the baseline dyspnea questionnaire and the transitional dyspnea questionnaire |
| Assess correlations between impulse oscillometry parameters and the extent of either fibrosis or emphysema lesions on CT scans | Baseline | Lesions are scored by trained observers. |
Countries
France
Outcome results
None listed