Metabolomics in Occupational Asthma

August 23, 2022 updated by: Bato Hammarstrøm, Oslo University Hospital

Pilot Study of Metabolomics in Occupational Asthma

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Norway
      • Oslo, Norway
        • Recruiting
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with occupational asthma, referred to the Unit of Environmental and Occupational medicine OUS for evaluation of OA.and healthy volunteers

Description

Inclusion Criteria:

  • capable of informed consent.
  • asthma diagnosis established by lung specialist or healthy control.

Exclusion Criteria:

  • skin allergy towards plastics or rubber.
  • immunocompromised by oral medication.
  • contagious respiratory disease.
  • biopsy of lung parenchyma within the last 36 hours.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Occupational Asthma
Patients refered for assesment of occupational asthma
Device: Breath Biopsy
ReCIVA breath sampler (Owlstone Medical, Cambridge, UK)
Respiratory Healthy Control
Employees at Oslo University Hospital
Device: Breath Biopsy
ReCIVA breath sampler (Owlstone Medical, Cambridge, UK)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discovery of VOC Biomarkers in Asthma
Time Frame: Baseline
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
Time Frame: Baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Owlstone Ltd

Investigators

  • Principal Investigator: Bato Hammarstrøm, MD/PhD, Oslo University Hospital
  • Study Chair: Hilde Heiro, MD, Oslo University Hospital
  • Study Chair: Britt G Randem, MD/PhD, Oslo University Hospital
  • Study Chair: Tonje Trulssen Hildre, M.Sc., Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

March 4, 2020

First Submitted That Met QC Criteria

March 5, 2020

First Posted (Actual)

March 10, 2020

Study Record Updates

Last Update Posted (Actual)

August 24, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UO1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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