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

N/AActive Not RecruitingNCT04680832

Erasmus Medical Center600 enrolled

Overview

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.

Patients will be included in the study after signing written informed consent. eNose measurements will take place before or after a routine outpatient clinic visit at the same location as the regular visit, ensuring minimal inconvenience for patients. 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. After the measurement, patients will complete a short survey about questions relevant for the data analysis (food intake in the last two hours, smoking history, medication use, comorbidities, and symptoms of respiratory infection). In addition, patients will complete the L-PF questionnaire and the Global Rating of Change scale (GRoC). The L-PF questionnaire consists of 21 questions on a 5-point Likert scale about the impact of pulmonary fibrosis on quality of life, and takes about 3 minutes to complete. The GRoC consists of one question on a scale from -7 to 7: were there any changes in your quality of life since your last visit? Symptoms (cough and dyspnea) will be scored on a 10 cm VAS scale from -5 to 5. Next to eNose measurements, demographic data and physiological parameters of patients will be collected from the medical records at baseline, month 6, and month 12. Parameters such as age, gender, diagnosis, time since diagnosis, comorbidities, medication, pulmonary function (forced vital capacity (FVC) and diffusion capacity of the lung for carbon monoxide (DLCO)), laboratory parameters (i.e. auto-immune antibodies), HRCT pattern, BAL results and if applicable also genetic mutations, will be recorded and stored in an electronic case report form. These parameters will be collected as part of routine daily care, patients will not undergo any additional tests for study purposes. HRCT scans will be re-analysed centrally by an experienced ILD thoracic radiologist. Mortality and lung function parameters will also be collected at 24 months, if this information is available.

Conditions

Pulmonary Fibrosis

Interventions

Electronic noseDIAGNOSTIC_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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (5)

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

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

Lyon, France

Thoraxklinik Heidelberg

Heidelberg, Germany

Erasmus MC

Rotterdam, Netherlands

Outcomes

Primary Outcomes

Diagnostic accuracy for IPF - CHP

Accuracy for differentiating IPF from CHP

Time frame: Baseline

AUC for IPF - CHP

AUC for differentiating IPF from CHP

Time frame: Baseline

AUC for IPF - iNSIP

AUC for differentiating IPF from iNSIP

Time frame: Baseline

Diagnostic accuracy for IPF - iNSIP

Accuracy for differentiating IPF from iNSIP

Time frame: Baseline

AUC for IPF - IPAF

AUC for differentiating IPF from IPAF

Time frame: Baseline

Diagnostic accuracy for IPF - IPAF

Accuracy for differentiating IPF from IPAF

Time frame: Baseline

Diagnostic accuracy for IPF - CTD-ILD

Accuracy for differentiating IPF from CTD-ILD

Time frame: Baseline

AUC for IPF - CTD-ILD

AUC for differentiating IPF from CTD-ILD

Time frame: Baseline

Diagnostic accuracy for IPF - unclassifiable ILD

Accuracy for differentiating IPF from unclassifiable ILD

Time frame: Baseline

AUC for IPF - unclassifiable ILD

AUC for differentiating IPF from unclassifiable ILD

Data from ClinicalTrials.gov

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Study Type

OBSERVATIONAL

Enrollment

600

Royal Brompton Hospital

London, United Kingdom

Time frame: Baseline

Diagnostic accuracy for CHP - iNSIP

Accuracy for differentiating CHP from iNSIP

Time frame: Baseline

AUC for CHP - iNSIP

AUC for differentiating CHP from iNSIP

Time frame: Baseline

Diagnostic accuracy for CHP - IPAF

Accuracy for differentiating CHP from IPAF

Time frame: Baseline

AUC for CHP - IPAF

AUC for differentiating CHP from IPAF

Time frame: Baseline

Diagnostic accuracy for CHP - CTD-ILD

Accuracy for differentiating CHP from CTD-ILD

Time frame: Baseline

AUC for CHP - CTD-ILD

AUC for differentiating CHP from CTD-ILD

Time frame: Baseline

Diagnostic accuracy for CHP - unclassifiable ILD

Accuracy for differentiating CHP from unclassifiable ILD

Time frame: Baseline

AUC for CHP - unclassifiable ILD

AUC for differentiating CHP from unclassifiable ILD

Time frame: Baseline

Diagnostic accuracy for iNSIP - IPAF

Accuracy for differentiating iNSIP from IPAF

Time frame: Baseline

AUC for iNSIP - IPAF

AUC for differentiating iNSIP from IPAF

Time frame: Baseline

Diagnostic accuracy for iNSIP - CTD-ILD

Accuracy for differentiating iNSIP from CTD-ILD

Time frame: Baseline

AUC for iNSIP - CTD-ILD

AUC for differentiating iNSIP from CTD-ILD

Time frame: Baseline

Diagnostic accuracy for iNSIP - unclassifiable ILD

Accuracy for differentiating iNSIP from unclassifiable ILD

Time frame: Baseline

AUC for iNSIP - unclassifiable ILD

AUC for differentiating iNSIP from unclassifiable ILD

Time frame: Baseline

Diagnostic accuracy for IPAF - CTD-ILD

Accuracy for differentiating IPAF from CTD-ILD

Time frame: Baseline

AUC for IPAF - CTD-ILD

AUC for differentiating IPAF from CTD-ILD

Time frame: Baseline

Diagnostic accuracy for IPAF - unclassifiable ILD

Accuracy for differentiating IPAF from unclassifiable ILD

Time frame: Baseline

AUC for IPAF - unclassifiable ILD

AUC for differentiating IPAF from unclassifiable ILD

Time frame: Baseline

Diagnostic accuracy for CTD-ILD - unclassifiable ILD

Accuracy for differentiating CTD-ILD from unclassifiable ILD

Time frame: Baseline

AUC for CTD-ILD - unclassifiable ILD

AUC for differentiating CTD-ILD from unclassifiable ILD

Time frame: Baseline

Disease progression

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 12 months after inclusion

Mortality

Deceased subjects

Time frame: 12 months after inclusion

Mortality

Deceased subjects

Time frame: 24 months after inclusion

Therapeutic effect

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

Time frame: 6 months after start therapy

Therapeutic effect

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

Time frame: 12 months after start therapy

Secondary Outcomes

L-PF evaluation

Relating Longitudinal changes in score of L-PF questionnaire to eNose values

Time frame: 6 months after inclusion

L-PF evaluation

Relating Longitudinal changes in score of L-PF questionnaire to lung function values

Time frame: 6 months after inclusion

L-PF evaluation

Relating Longitudinal changes in score of L-PF questionnaire to eNose values

Time frame: 12 months after inclusion

L-PF evaluation

Relating Longitudinal changes in score of L-PF questionnaire to lung function values

Time frame: 12 months after inclusion

L-PF evaluation

Relating Longitudinal changes in score of L-PF questionnaire to eNose values

Time frame: 24 months after inclusion

L-PF evaluation

Relating Longitudinal changes in score of L-PF questionnaire to lung function values

Time frame: 24 months after inclusion

GRoC evaluation

Relating Longitudinal changes in score of Global Rating of Change Scale to eNose values

Time frame: 6 months after inclusion

GRoC evaluation

Relating Longitudinal changes in score of Global Rating of Change Scale to lung function values

Time frame: 6 months after inclusion

GRoC evaluation

Relating Longitudinal changes in score of Global Rating of Change Scale to eNose values

Time frame: 12 months after inclusion

GRoC evaluation

Relating Longitudinal changes in score of Global Rating of Change Scale to lung function values

Time frame: 12 months after inclusion

GRoC evaluation

Relating Longitudinal changes in score of Global Rating of Change Scale to eNose values

Time frame: 24 months after inclusion

GRoC evaluation

Relating Longitudinal changes in score of Global Rating of Change Scale to lung function values

Time frame: 24 months after inclusion