Electronic nose: First, patients will be asked to rinse their mouth thoroughly with water three times. Subsequently, exhaled breath analysis will be performed in duplicate with a 1-minute interval. An eNose measurement consists of five tidal breaths, followed by an inspiratory capacity maneuver to total lung capacity, a five second breath hold, and subsequently a slow expiration (flow \<0.4L/s) to residual volume. The measurements are non-invasive and will cost approximately 5-10 minutes in total, including explanation and informed consent procedure. There are no risks associated with this study and the burden for patients is minimal.
Study summary
The ILDnose study a multinational, multicenter, prospective, longitudinal study in outpatients with pulmonary fibrosis. The aim is to assess the accuracy of eNose technology as diagnostic tool for diagnosis and differentiation between the most prevalent fibrotic interstitial lung diseases. The value of eNose as biomarker for disease progression and response to treatment is also assessed. Besides, validity of several questionnaires for pulmonary fibrosis is investigated.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patients with a diagnosis of fibrotic ILD, as discussed in a multidisciplinary team meeting (50% incident patients and 50% prevalent patients). Patients are classified as 'incident' if they received a diagnosed in a multidisciplinary team meeting within the past six months. Patients will be required to have fibrosis on a HRCT scan \<1 year before enrollment in the study defined as reticular abnormality with traction bronchiectasis, with or without honeycombing, as determined by a radiologist. No minimum extent of fibrosis will be required.
Exclusion Criteria:
* Alcohol consumption ≤ 12 hours before the measurement
* Physically not able to perform eNose measurement
Primary outcome measure(s)
Diagnostic accuracy for IPF - CHP — Baseline Accuracy for differentiating IPF from CHP
AUC for IPF - CHP — Baseline AUC for differentiating IPF from CHP
AUC for IPF - iNSIP — Baseline AUC for differentiating IPF from iNSIP
Diagnostic accuracy for IPF - iNSIP — Baseline Accuracy for differentiating IPF from iNSIP
AUC for IPF - IPAF — Baseline AUC for differentiating IPF from IPAF
Diagnostic accuracy for IPF - IPAF — Baseline Accuracy for differentiating IPF from IPAF
Diagnostic accuracy for IPF - CTD-ILD — Baseline Accuracy for differentiating IPF from CTD-ILD
AUC for IPF - CTD-ILD — Baseline AUC for differentiating IPF from CTD-ILD
Diagnostic accuracy for IPF - unclassifiable ILD — Baseline Accuracy for differentiating IPF from unclassifiable ILD
AUC for IPF - unclassifiable ILD — Baseline AUC for differentiating IPF from unclassifiable ILD
Diagnostic accuracy for CHP - iNSIP — Baseline Accuracy for differentiating CHP from iNSIP
AUC for CHP - iNSIP — Baseline AUC for differentiating CHP from iNSIP
Diagnostic accuracy for CHP - IPAF — Baseline Accuracy for differentiating CHP from IPAF
AUC for CHP - IPAF — Baseline AUC for differentiating CHP from IPAF
Diagnostic accuracy for CHP - CTD-ILD — Baseline Accuracy for differentiating CHP from CTD-ILD
AUC for CHP - CTD-ILD — Baseline AUC for differentiating CHP from CTD-ILD
Diagnostic accuracy for CHP - unclassifiable ILD — Baseline Accuracy for differentiating CHP from unclassifiable ILD
AUC for CHP - unclassifiable ILD — Baseline AUC for differentiating CHP from unclassifiable ILD
Diagnostic accuracy for iNSIP - IPAF — Baseline Accuracy for differentiating iNSIP from IPAF
AUC for iNSIP - IPAF — Baseline AUC for differentiating iNSIP from IPAF
Diagnostic accuracy for iNSIP - CTD-ILD — Baseline Accuracy for differentiating iNSIP from CTD-ILD
AUC for iNSIP - CTD-ILD — Baseline AUC for differentiating iNSIP from CTD-ILD
Diagnostic accuracy for iNSIP - unclassifiable ILD — Baseline Accuracy for differentiating iNSIP from unclassifiable ILD
AUC for iNSIP - unclassifiable ILD — Baseline AUC for differentiating iNSIP from unclassifiable ILD
Diagnostic accuracy for IPAF - CTD-ILD — Baseline Accuracy for differentiating IPAF from CTD-ILD
AUC for IPAF - CTD-ILD — Baseline AUC for differentiating IPAF from CTD-ILD
Diagnostic accuracy for IPAF - unclassifiable ILD — Baseline Accuracy for differentiating IPAF from unclassifiable ILD
AUC for IPAF - unclassifiable ILD — Baseline AUC for differentiating IPAF from unclassifiable ILD
Diagnostic accuracy for CTD-ILD - unclassifiable ILD — Baseline Accuracy for differentiating CTD-ILD from unclassifiable ILD
AUC for CTD-ILD - unclassifiable ILD — Baseline AUC for differentiating CTD-ILD from unclassifiable ILD
Disease progression — 12 months after inclusion FVC decline in combination with worsening of respiratory symptoms (cough and/or dyspnea) and/or progressive fibrosis on CT scan
Disease progression — 24 months after inclusion FVC decline in combination with worsening of respiratory symptoms (cough and/or dyspnea) and/or progressive fibrosis on CT scan
Diagnostic accuracy of disease progression — 6 months after inclusion Relating disease progression (based on FVC decline, CT scan and/or symptoms) to change in eNose values
Diagnostic accuracy of disease progression — 12 months after inclusion Relating disease progression (based on FVC decline, CT scan and/or symptoms) to change in eNose values
Diagnostic accuracy of disease progression — 24 months after inclusion Relating disease progression (based on FVC decline, CT scan and/or symptoms) to change in eNose values
Worsening of respiratory symptoms (cough and/or dyspnea) — 12 months after inclusion Worsening of respiratory symptoms (cough and/or dyspnea) measured on a visual analogue scale (0-10, 0 no symptoms, 10 most severe symptoms)
Mortality — 12 months after inclusion Deceased subjects
Mortality — 24 months after inclusion Deceased subjects
Therapeutic effect — 6 months after start therapy Relating start of anti-fibrotic medication to change in eNose values
Therapeutic effect — 12 months after start therapy Relating start of anti-fibrotic medication to change in eNose values
Trial sites (5)
Facility
City
Region
Status
Royal Prince Alfred Hospital
Camperdown
New South Wales
University Lyon 1, Louis Pradel hospital, Lyon. FranceService de pneumologie, hôpital Louis Pradel
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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