Metabolomics in Occupational Asthma

Asthma, Occupational Clinical Trial

Official title:

Pilot Study of Metabolomics in Occupational Asthma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04301674
• Other study ID #: UO1
• Status: Recruiting
• Start date: October 15, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: August 2022
• Source: Oslo University Hospital
• Contact: Bato Hammarström, MD/PhD
• Phone: +47 230 16667
• Email: bato.hammarstrom[@]ous-hf.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma, Occupational

Intervention

Device:
• Breath Biopsy
ReCIVA breath sampler (Owlstone Medical, Cambridge, UK)

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Owlstone Ltd

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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