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

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ClinicalTrials.gov Identifier: NCT04680832
Recruitment Status : Recruiting
First Posted : December 23, 2020
Last Update Posted : December 23, 2020
Sponsor:
Information provided by (Responsible Party):
Marlies Wijsenbeek, Erasmus Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pulmonary Fibrosis Diagnostic Test: Electronic nose Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Exhaled Breath Analysis Using eNose Technology as a Biomarker for Diagnosis and Disease Progression in Fibrotic Interstitial Lung Disease
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
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.
Other Names:
  • SpiroNose
  • eNose


Outcome Measures
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Primary Outcome Measures :
  1. Diagnostic accuracy for IPF - CHP [ Time Frame: Baseline ]
    Accuracy for differentiating IPF from CHP

  2. AUC for IPF - CHP [ Time Frame: Baseline ]
    AUC for differentiating IPF from CHP

  3. AUC for IPF - iNSIP [ Time Frame: Baseline ]
    AUC for differentiating IPF from iNSIP

  4. Diagnostic accuracy for IPF - iNSIP [ Time Frame: Baseline ]
    Accuracy for differentiating IPF from iNSIP

  5. AUC for IPF - IPAF [ Time Frame: Baseline ]
    AUC for differentiating IPF from IPAF

  6. Diagnostic accuracy for IPF - IPAF [ Time Frame: Baseline ]
    Accuracy for differentiating IPF from IPAF

  7. Diagnostic accuracy for IPF - CTD-ILD [ Time Frame: Baseline ]
    Accuracy for differentiating IPF from CTD-ILD

  8. AUC for IPF - CTD-ILD [ Time Frame: Baseline ]
    AUC for differentiating IPF from CTD-ILD

  9. Diagnostic accuracy for IPF - unclassifiable ILD [ Time Frame: Baseline ]
    Accuracy for differentiating IPF from unclassifiable ILD

  10. AUC for IPF - unclassifiable ILD [ Time Frame: Baseline ]
    AUC for differentiating IPF from unclassifiable ILD

  11. Diagnostic accuracy for CHP - iNSIP [ Time Frame: Baseline ]
    Accuracy for differentiating CHP from iNSIP

  12. AUC for CHP - iNSIP [ Time Frame: Baseline ]
    AUC for differentiating CHP from iNSIP

  13. Diagnostic accuracy for CHP - IPAF [ Time Frame: Baseline ]
    Accuracy for differentiating CHP from IPAF

  14. AUC for CHP - IPAF [ Time Frame: Baseline ]
    AUC for differentiating CHP from IPAF

  15. Diagnostic accuracy for CHP - CTD-ILD [ Time Frame: Baseline ]
    Accuracy for differentiating CHP from CTD-ILD

  16. AUC for CHP - CTD-ILD [ Time Frame: Baseline ]
    AUC for differentiating CHP from CTD-ILD

  17. Diagnostic accuracy for CHP - unclassifiable ILD [ Time Frame: Baseline ]
    Accuracy for differentiating CHP from unclassifiable ILD

  18. AUC for CHP - unclassifiable ILD [ Time Frame: Baseline ]
    AUC for differentiating CHP from unclassifiable ILD

  19. Diagnostic accuracy for iNSIP - IPAF [ Time Frame: Baseline ]
    Accuracy for differentiating iNSIP from IPAF

  20. AUC for iNSIP - IPAF [ Time Frame: Baseline ]
    AUC for differentiating iNSIP from IPAF

  21. Diagnostic accuracy for iNSIP - CTD-ILD [ Time Frame: Baseline ]
    Accuracy for differentiating iNSIP from CTD-ILD

  22. AUC for iNSIP - CTD-ILD [ Time Frame: Baseline ]
    AUC for differentiating iNSIP from CTD-ILD

  23. Diagnostic accuracy for iNSIP - unclassifiable ILD [ Time Frame: Baseline ]
    Accuracy for differentiating iNSIP from unclassifiable ILD

  24. AUC for iNSIP - unclassifiable ILD [ Time Frame: Baseline ]
    AUC for differentiating iNSIP from unclassifiable ILD

  25. Diagnostic accuracy for IPAF - CTD-ILD [ Time Frame: Baseline ]
    Accuracy for differentiating IPAF from CTD-ILD

  26. AUC for IPAF - CTD-ILD [ Time Frame: Baseline ]
    AUC for differentiating IPAF from CTD-ILD

  27. Diagnostic accuracy for IPAF - unclassifiable ILD [ Time Frame: Baseline ]
    Accuracy for differentiating IPAF from unclassifiable ILD

  28. AUC for IPAF - unclassifiable ILD [ Time Frame: Baseline ]
    AUC for differentiating IPAF from unclassifiable ILD

  29. Diagnostic accuracy for CTD-ILD - unclassifiable ILD [ Time Frame: Baseline ]
    Accuracy for differentiating CTD-ILD from unclassifiable ILD

  30. AUC for CTD-ILD - unclassifiable ILD [ Time Frame: Baseline ]
    AUC for differentiating CTD-ILD from unclassifiable ILD

  31. Disease progression [ Time Frame: 12 months after inclusion ]
    FVC decline in combination with worsening of respiratory symptoms (cough and/or dyspnea) and/or progressive fibrosis on CT scan

  32. Disease progression [ Time Frame: 24 months after inclusion ]
    FVC decline in combination with worsening of respiratory symptoms (cough and/or dyspnea) and/or progressive fibrosis on CT scan

  33. Diagnostic accuracy of disease progression [ Time Frame: 6 months after inclusion ]
    Relating disease progression (based on FVC decline, CT scan and/or symptoms) to change in eNose values

  34. Diagnostic accuracy of disease progression [ Time Frame: 12 months after inclusion ]
    Relating disease progression (based on FVC decline, CT scan and/or symptoms) to change in eNose values

  35. Diagnostic accuracy of disease progression [ Time Frame: 24 months after inclusion ]
    Relating disease progression (based on FVC decline, CT scan and/or symptoms) to change in eNose values

  36. Worsening of respiratory symptoms (cough and/or dyspnea) [ Time Frame: 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)

  37. Mortality [ Time Frame: 12 months after inclusion ]
    Deceased subjects

  38. Mortality [ Time Frame: 24 months after inclusion ]
    Deceased subjects

  39. Therapeutic effect [ Time Frame: 6 months after start therapy ]
    Relating start of anti-fibrotic medication to change in eNose values

  40. Therapeutic effect [ Time Frame: 12 months after start therapy ]
    Relating start of anti-fibrotic medication to change in eNose values


Secondary Outcome Measures :
  1. L-PF evaluation [ Time Frame: 6 months after inclusion ]
    Relating Longitudinal changes in score of L-PF questionnaire to eNose values

  2. L-PF evaluation [ Time Frame: 6 months after inclusion ]
    Relating Longitudinal changes in score of L-PF questionnaire to lung function values

  3. L-PF evaluation [ Time Frame: 12 months after inclusion ]
    Relating Longitudinal changes in score of L-PF questionnaire to eNose values

  4. L-PF evaluation [ Time Frame: 12 months after inclusion ]
    Relating Longitudinal changes in score of L-PF questionnaire to lung function values

  5. L-PF evaluation [ Time Frame: 24 months after inclusion ]
    Relating Longitudinal changes in score of L-PF questionnaire to eNose values

  6. L-PF evaluation [ Time Frame: 24 months after inclusion ]
    Relating Longitudinal changes in score of L-PF questionnaire to lung function values

  7. GRoC evaluation [ Time Frame: 6 months after inclusion ]
    Relating Longitudinal changes in score of Global Rating of Change Scale to eNose values

  8. GRoC evaluation [ Time Frame: 6 months after inclusion ]
    Relating Longitudinal changes in score of Global Rating of Change Scale to lung function values

  9. GRoC evaluation [ Time Frame: 12 months after inclusion ]
    Relating Longitudinal changes in score of Global Rating of Change Scale to eNose values

  10. GRoC evaluation [ Time Frame: 12 months after inclusion ]
    Relating Longitudinal changes in score of Global Rating of Change Scale to lung function values

  11. GRoC evaluation [ Time Frame: 24 months after inclusion ]
    Relating Longitudinal changes in score of Global Rating of Change Scale to eNose values

  12. GRoC evaluation [ Time Frame: 24 months after inclusion ]
    Relating Longitudinal changes in score of Global Rating of Change Scale to lung function values


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04680832


Contacts
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Contact: Marlies S Wijsenbeek, MD PhD +31107030323 ext +31107030323 m.wijsenbeek-lourens@erasmusmc.nl

Locations
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France
University Lyon 1, Louis Pradel hospital, Lyon. FranceService de pneumologie, hôpital Louis Pradel Not yet recruiting
Lyon, France
Contact: Vincent Cottin, Prof.    +33472357652    vincent.cottin@chu-lyon.fr   
Germany
Thoraxklinik Heidelberg Not yet recruiting
Heidelberg, Germany, 69126
Contact: Michael Kreuter, Prof Dr    062213960 ext 062213960    kreuter@uni-heidelberg.de   
Netherlands
Erasmus MC Recruiting
Rotterdam, Netherlands, 3000 CA
Contact: Iris G van der Sar, MD    0031611056352 ext 0031611056352    i.g.vandersar@erasmusmc.nl   
Principal Investigator: Marlies S Wijsenbeek, MD PhD         
United Kingdom
Royal Brompton Hospital Not yet recruiting
London, United Kingdom, SW3 6NP
Contact: Philip L Molyneaux    +442073528121 ext +442073528121    p.molyneaux@imperial.ac.uk   
Sponsors and Collaborators
Erasmus Medical Center
Investigators
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Principal Investigator: Marlies S Wijsenbeek, MD PhD Erasmus MC
More Information
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Responsible Party: Marlies Wijsenbeek, Principal Investigator, MD PhD, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT04680832    
Other Study ID Numbers: MEC-2020-0655
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: December 23, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Disease Progression
Pathologic Processes
 Disease Attributes
Lung Diseases
Respiratory Tract Diseases