Exhaled Breath Analysis Using eNose Technology as a Biomarker for Diagnosis and Disease Progression in Fibrotic ILD

NCT04680832 | Active Not Recruiting

• 1 other identifier: MEC-2020-0655
• Study Type: observational
• Target: 600
• Locations: 5 countries
• Sites: 5

Brief 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.

Conditions

Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (40)

• Diagnostic accuracy for IPF - CHP

  Accuracy for differentiating IPF from CHP

  Baseline

• AUC for IPF - CHP

  AUC for differentiating IPF from CHP

  Baseline

• AUC for IPF - iNSIP

  AUC for differentiating IPF from iNSIP

  Baseline

• Diagnostic accuracy for IPF - iNSIP

  Accuracy for differentiating IPF from iNSIP

  Baseline

• AUC for IPF - IPAF

  AUC for differentiating IPF from IPAF

  Baseline

• Diagnostic accuracy for IPF - IPAF

  Accuracy for differentiating IPF from IPAF

  Baseline

• Diagnostic accuracy for IPF - CTD-ILD

  Accuracy for differentiating IPF from CTD-ILD

  Baseline

• AUC for IPF - CTD-ILD

  AUC for differentiating IPF from CTD-ILD

  Baseline

• Diagnostic accuracy for IPF - unclassifiable ILD

  Accuracy for differentiating IPF from unclassifiable ILD

  Baseline

• AUC for IPF - unclassifiable ILD

  AUC for differentiating IPF from unclassifiable ILD

  Baseline

• Diagnostic accuracy for CHP - iNSIP

  Accuracy for differentiating CHP from iNSIP

  Baseline

• AUC for CHP - iNSIP

  AUC for differentiating CHP from iNSIP

  Baseline

• Diagnostic accuracy for CHP - IPAF

  Accuracy for differentiating CHP from IPAF

  Baseline

• AUC for CHP - IPAF

  AUC for differentiating CHP from IPAF

  Baseline

• Diagnostic accuracy for CHP - CTD-ILD

  Accuracy for differentiating CHP from CTD-ILD

  Baseline

• AUC for CHP - CTD-ILD

  AUC for differentiating CHP from CTD-ILD

  Baseline

• Diagnostic accuracy for CHP - unclassifiable ILD

  Accuracy for differentiating CHP from unclassifiable ILD

  Baseline

• AUC for CHP - unclassifiable ILD

  AUC for differentiating CHP from unclassifiable ILD

  Baseline

• Diagnostic accuracy for iNSIP - IPAF

  Accuracy for differentiating iNSIP from IPAF

  Baseline

• AUC for iNSIP - IPAF

  AUC for differentiating iNSIP from IPAF

  Baseline

• Diagnostic accuracy for iNSIP - CTD-ILD

  Accuracy for differentiating iNSIP from CTD-ILD

  Baseline

• AUC for iNSIP - CTD-ILD

  AUC for differentiating iNSIP from CTD-ILD

  Baseline

• Diagnostic accuracy for iNSIP - unclassifiable ILD

  Accuracy for differentiating iNSIP from unclassifiable ILD

  Baseline

• AUC for iNSIP - unclassifiable ILD

  AUC for differentiating iNSIP from unclassifiable ILD

  Baseline

• Diagnostic accuracy for IPAF - CTD-ILD

  Accuracy for differentiating IPAF from CTD-ILD

  Baseline

• AUC for IPAF - CTD-ILD

  AUC for differentiating IPAF from CTD-ILD

  Baseline

• Diagnostic accuracy for IPAF - unclassifiable ILD

  Accuracy for differentiating IPAF from unclassifiable ILD

  Baseline

• AUC for IPAF - unclassifiable ILD

  AUC for differentiating IPAF from unclassifiable ILD

  Baseline

• Diagnostic accuracy for CTD-ILD - unclassifiable ILD

  Accuracy for differentiating CTD-ILD from unclassifiable ILD

  Baseline

• AUC for CTD-ILD - unclassifiable ILD

  AUC for differentiating CTD-ILD from unclassifiable ILD

  Baseline

• Disease progression

  FVC decline in combination with worsening of respiratory symptoms (cough and/or dyspnea) and/or progressive fibrosis on CT scan

  12 months after inclusion

• Disease progression

  FVC decline in combination with worsening of respiratory symptoms (cough and/or dyspnea) and/or progressive fibrosis on CT scan

  24 months after inclusion

• Diagnostic accuracy of disease progression

  Relating disease progression (based on FVC decline, CT scan and/or symptoms) to change in eNose values

  6 months after inclusion

• Diagnostic accuracy of disease progression

  Relating disease progression (based on FVC decline, CT scan and/or symptoms) to change in eNose values

  12 months after inclusion

• Diagnostic accuracy of disease progression

  Relating disease progression (based on FVC decline, CT scan and/or symptoms) to change in eNose values

  24 months after inclusion

• Worsening of respiratory symptoms (cough and/or dyspnea)

  Worsening of respiratory symptoms (cough and/or dyspnea) measured on a visual analogue scale (0-10, 0 no symptoms, 10 most severe symptoms)

  12 months after inclusion

• Mortality

  Deceased subjects

  12 months after inclusion

• Mortality

  Deceased subjects

  24 months after inclusion

• Therapeutic effect

  Relating start of anti-fibrotic medication to change in eNose values

  6 months after start therapy

• Therapeutic effect

  Relating start of anti-fibrotic medication to change in eNose values

  12 months after start therapy

Secondary Outcomes (12)

• L-PF evaluation

  6 months after inclusion

• L-PF evaluation

  6 months after inclusion

• L-PF evaluation

  12 months after inclusion

• L-PF evaluation

  12 months after inclusion

• L-PF evaluation

  24 months after inclusion

Study Arms (1)

ILD patients

Patients diagnosed with one of the most prevalent fibrotic ILDs: IPF, CHP, CTD-ILD, iNSIP, IPAF, and unclassifiable ILD (defined as unclassifiable disease at the time of the first MDT).

Diagnostic Test: Electronic nose

Interventions

Electronic nose DIAGNOSTIC_TEST

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.

Also known as: SpiroNose, eNose

ILD patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with ILD

You may qualify if:

• 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.

You may not qualify if:

• Alcohol consumption ≤ 12 hours before the measurement
• Physically not able to perform eNose measurement

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (5)

Royal Prince Alfred Hospital

Camperdown, New South Wales, NSW 2050, Australia

Location

University Lyon 1, Louis Pradel hospital, Lyon. FranceService de pneumologie, hôpital Louis Pradel

Lyon, France

Location

Thoraxklinik Heidelberg

Heidelberg, 69126, Germany

Location

Erasmus MC

Rotterdam, 3000 CA, Netherlands

Location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marlies S Wijsenbeek, MD PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD PhD

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 23, 2020
• Study Start: November 1, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); AU (1); NL (1); DE (1); GB (1)