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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04680832




Registration number
NCT04680832
Ethics application status
Date submitted
11/12/2020
Date registered
23/12/2020
Date last updated
30/05/2025

Titles & IDs
Public title
Exhaled Breath Analysis Using eNose Technology as a Biomarker for Diagnosis and Disease Progression in Fibrotic ILD
Scientific title
Exhaled Breath Analysis Using eNose Technology as a Biomarker for Diagnosis and Disease Progression in Fibrotic Interstitial Lung Disease
Secondary ID [1] 0 0
MEC-2020-0655
Universal Trial Number (UTN)
Trial acronym
ILDnose
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Fibrosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - Electronic nose

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).


Diagnosis / Prognosis: 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.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Diagnostic accuracy for IPF - CHP
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
AUC for IPF - CHP
Timepoint [2] 0 0
Baseline
Primary outcome [3] 0 0
AUC for IPF - iNSIP
Timepoint [3] 0 0
Baseline
Primary outcome [4] 0 0
Diagnostic accuracy for IPF - iNSIP
Timepoint [4] 0 0
Baseline
Primary outcome [5] 0 0
AUC for IPF - IPAF
Timepoint [5] 0 0
Baseline
Primary outcome [6] 0 0
Diagnostic accuracy for IPF - IPAF
Timepoint [6] 0 0
Baseline
Primary outcome [7] 0 0
Diagnostic accuracy for IPF - CTD-ILD
Timepoint [7] 0 0
Baseline
Primary outcome [8] 0 0
AUC for IPF - CTD-ILD
Timepoint [8] 0 0
Baseline
Primary outcome [9] 0 0
Diagnostic accuracy for IPF - unclassifiable ILD
Timepoint [9] 0 0
Baseline
Primary outcome [10] 0 0
AUC for IPF - unclassifiable ILD
Timepoint [10] 0 0
Baseline
Primary outcome [11] 0 0
Diagnostic accuracy for CHP - iNSIP
Timepoint [11] 0 0
Baseline
Primary outcome [12] 0 0
AUC for CHP - iNSIP
Timepoint [12] 0 0
Baseline
Primary outcome [13] 0 0
Diagnostic accuracy for CHP - IPAF
Timepoint [13] 0 0
Baseline
Primary outcome [14] 0 0
AUC for CHP - IPAF
Timepoint [14] 0 0
Baseline
Primary outcome [15] 0 0
Diagnostic accuracy for CHP - CTD-ILD
Timepoint [15] 0 0
Baseline
Primary outcome [16] 0 0
AUC for CHP - CTD-ILD
Timepoint [16] 0 0
Baseline
Primary outcome [17] 0 0
Diagnostic accuracy for CHP - unclassifiable ILD
Timepoint [17] 0 0
Baseline
Primary outcome [18] 0 0
AUC for CHP - unclassifiable ILD
Timepoint [18] 0 0
Baseline
Primary outcome [19] 0 0
Diagnostic accuracy for iNSIP - IPAF
Timepoint [19] 0 0
Baseline
Primary outcome [20] 0 0
AUC for iNSIP - IPAF
Timepoint [20] 0 0
Baseline
Primary outcome [21] 0 0
Diagnostic accuracy for iNSIP - CTD-ILD
Timepoint [21] 0 0
Baseline
Primary outcome [22] 0 0
AUC for iNSIP - CTD-ILD
Timepoint [22] 0 0
Baseline
Primary outcome [23] 0 0
Diagnostic accuracy for iNSIP - unclassifiable ILD
Timepoint [23] 0 0
Baseline
Primary outcome [24] 0 0
AUC for iNSIP - unclassifiable ILD
Timepoint [24] 0 0
Baseline
Primary outcome [25] 0 0
Diagnostic accuracy for IPAF - CTD-ILD
Timepoint [25] 0 0
Baseline
Primary outcome [26] 0 0
AUC for IPAF - CTD-ILD
Timepoint [26] 0 0
Baseline
Primary outcome [27] 0 0
Diagnostic accuracy for IPAF - unclassifiable ILD
Timepoint [27] 0 0
Baseline
Primary outcome [28] 0 0
AUC for IPAF - unclassifiable ILD
Timepoint [28] 0 0
Baseline
Primary outcome [29] 0 0
Diagnostic accuracy for CTD-ILD - unclassifiable ILD
Timepoint [29] 0 0
Baseline
Primary outcome [30] 0 0
AUC for CTD-ILD - unclassifiable ILD
Timepoint [30] 0 0
Baseline
Primary outcome [31] 0 0
Disease progression
Timepoint [31] 0 0
12 months after inclusion
Primary outcome [32] 0 0
Disease progression
Timepoint [32] 0 0
24 months after inclusion
Primary outcome [33] 0 0
Diagnostic accuracy of disease progression
Timepoint [33] 0 0
6 months after inclusion
Primary outcome [34] 0 0
Diagnostic accuracy of disease progression
Timepoint [34] 0 0
12 months after inclusion
Primary outcome [35] 0 0
Diagnostic accuracy of disease progression
Timepoint [35] 0 0
24 months after inclusion
Primary outcome [36] 0 0
Worsening of respiratory symptoms (cough and/or dyspnea)
Timepoint [36] 0 0
12 months after inclusion
Primary outcome [37] 0 0
Mortality
Timepoint [37] 0 0
12 months after inclusion
Primary outcome [38] 0 0
Mortality
Timepoint [38] 0 0
24 months after inclusion
Primary outcome [39] 0 0
Therapeutic effect
Timepoint [39] 0 0
6 months after start therapy
Primary outcome [40] 0 0
Therapeutic effect
Timepoint [40] 0 0
12 months after start therapy
Secondary outcome [1] 0 0
L-PF evaluation
Timepoint [1] 0 0
6 months after inclusion
Secondary outcome [2] 0 0
L-PF evaluation
Timepoint [2] 0 0
6 months after inclusion
Secondary outcome [3] 0 0
L-PF evaluation
Timepoint [3] 0 0
12 months after inclusion
Secondary outcome [4] 0 0
L-PF evaluation
Timepoint [4] 0 0
12 months after inclusion
Secondary outcome [5] 0 0
L-PF evaluation
Timepoint [5] 0 0
24 months after inclusion
Secondary outcome [6] 0 0
L-PF evaluation
Timepoint [6] 0 0
24 months after inclusion
Secondary outcome [7] 0 0
GRoC evaluation
Timepoint [7] 0 0
6 months after inclusion
Secondary outcome [8] 0 0
GRoC evaluation
Timepoint [8] 0 0
6 months after inclusion
Secondary outcome [9] 0 0
GRoC evaluation
Timepoint [9] 0 0
12 months after inclusion
Secondary outcome [10] 0 0
GRoC evaluation
Timepoint [10] 0 0
12 months after inclusion
Secondary outcome [11] 0 0
GRoC evaluation
Timepoint [11] 0 0
24 months after inclusion
Secondary outcome [12] 0 0
GRoC evaluation
Timepoint [12] 0 0
24 months after inclusion

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Alcohol consumption = 12 hours before the measurement
* Physically not able to perform eNose measurement

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 0 0
NSW 2050 - Camperdown
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Lyon
Country [2] 0 0
Germany
State/province [2] 0 0
Heidelberg
Country [3] 0 0
Netherlands
State/province [3] 0 0
Rotterdam
Country [4] 0 0
United Kingdom
State/province [4] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Erasmus Medical Center
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marlies S Wijsenbeek, MD PhD
Address 0 0
Erasmus Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04680832