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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A02300-55 | Other Identifier | IdRCB |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Impulse Oscillometry | Diagnostic Test | Impulse Oscillometry will be performed in addition to usual care |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Performance of baseline impulse oscillometry parameters for the diagnosis of rapid decline in lung function |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Idiopathic Pulmonary Fibrosis
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| Name | Affiliation | Role |
|---|---|---|
| Laurent PLANTIER, MD-PhD | University Hospital, Tours | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Respiratory Functional Explorations, University Hospital, Lille | Lille | 59037 | France | |||
| Respiratory Functional Explorations, University Hospital, Nantes |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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Receiver operating characteristics curves will be used to determine diagnostic performance. |
| Baseline, 3 months, 6 months |
| 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 |
| 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 |
| 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 |
| Nantes |
| 44093 |
| France |
| Department of digestive physiology, urinary, respiratory and exercise, University Hospital, Rouen | Rouen | France |
| Pulmonology Department, University Hospital, Tours | Tours | 37044 | France |