Metabolomics in Occupational Asthma
Pilot Study of Metabolomics in Occupational Asthma
1 other identifier
observational
80
1 country
1
Brief Summary
The project aims to increase the diagnostic accuracy in occupational asthma (OA), with emphasis on Irritant Induced Asthma (IIA). Currently, most patients are evaluated in occupational medicine by comparing the exposure and symptom characteristics with epidemiological data. Biological markers may be present in AA, but presently not in IIA. The majority of cases evaluated are considered as possible IIA, i.e. low-dose multiple exposures. VOC features will be analyzed with the Breath Biopsy® and TD-GS-MS (Owlstone Medical Ltd, UK).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2020
CompletedFirst Posted
Study publicly available on registry
March 10, 2020
CompletedStudy Start
First participant enrolled
October 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedAugust 24, 2022
August 1, 2022
1.2 years
March 4, 2020
August 23, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Discovery of VOC Biomarkers in Asthma
To evaluate the sensitivity, specificity, positive and negative predictive value of VOC biomarkers in exhaled breath samples to identify asthma.
Baseline
Discovery of VOC Biomarkers in Occupational Irritant Asthma
To evaluate the sensitivity, specificity, positive and negative predictive value of VOC biomarkers in exhaled breath samples to identify irritant asthma after occupational exposures.
Baseline
Study Arms (2)
Occupational Asthma
Patients refered for assesment of occupational asthma
Respiratory Healthy Control
Employees at Oslo University Hospital
Interventions
ReCIVA breath sampler (Owlstone Medical, Cambridge, UK)
Eligibility Criteria
Patients with occupational asthma, referred to the Unit of Environmental and Occupational medicine OUS for evaluation of OA.and healthy volunteers
You may qualify if:
- capable of informed consent.
- asthma diagnosis established by lung specialist or healthy control.
You may not qualify if:
- skin allergy towards plastics or rubber.
- immunocompromised by oral medication.
- contagious respiratory disease.
- biopsy of lung parenchyma within the last 36 hours.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oslo University Hospitallead
- Owlstone Ltdcollaborator
Study Sites (1)
Oslo University Hospital
Oslo, Norway
Biospecimen
Volatile Organic Compounds (VOC) in exhaled air
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bato Hammarstrøm, MD/PhD
Oslo University Hospital
- STUDY CHAIR
Tonje Trulssen Hildre, M.Sc.
Oslo University Hospital
- STUDY CHAIR
Hilde Heiro, MD
Oslo University Hospital
- STUDY CHAIR
Britt G Randem, MD/PhD
Oslo University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior consultant/Research group leader
Study Record Dates
First Submitted
March 4, 2020
First Posted
March 10, 2020
Study Start
October 15, 2021
Primary Completion
December 31, 2022
Study Completion
June 1, 2023
Last Updated
August 24, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share