Asthma, OccupationalNCT04301674
Metabolomics in Occupational Asthma
An observational study of Asthma, Occupational, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma, Occupational
- What is being tested?
- Breath Biopsy
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- 15 Oct 2021to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with occupational asthma, referred to the Unit of Environmental and Occupational medicine OUS for evaluation of OA.and healthy volunteers
Who may be able to join
- capable of informed consent.
- asthma diagnosis established by lung specialist or healthy control.
Who cannot join
- skin allergy towards plastics or rubber.
- immunocompromised by oral medication.
- contagious respiratory disease.
- biopsy of lung parenchyma within the last 36 hours.
Trial locations and contacts
1 site in 1 country.
Tonje Trulssen Hildre, M.Sc. contact
About this study
Official title: 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).
- Conditions
- Asthma, Occupational
- Being tested
- Breath Biopsy
- Medical subject headings
- Asthma, Occupational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath BiopsyDevice
ReCIVA breath sampler (Owlstone Medical, Cambridge, UK)
| Study group | Role | What they receive |
|---|---|---|
| Occupational Asthma | Patients refered for assesment of occupational asthma Receives: Device: Breath Biopsy | |
| Respiratory Healthy Control | Employees at Oslo University Hospital Receives: Device: Breath Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start15 Oct 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma, OccupationalStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Owlstone Ltd
- Responsible party
- Principal investigator, Bato Hammarstrøm, Oslo University Hospital
- Investigators
- Bato Hammarstrøm, MD/PhD, Principal investigator, Oslo University HospitalTonje Trulssen Hildre, M.Sc., Study chair, Oslo University HospitalHilde Heiro, MD, Study chair, Oslo University HospitalBritt G Randem, MD/PhD, Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301674
- Sponsor's protocol ID
- UO1
- Status last verified
- Aug 2022
- First submitted
- 4 Mar 2020
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Metabolomics in Occupational Asthma
- ClinicalTrials.gov ID
- NCT04301674
- Acronym / sponsor ID
- UO1
- Conditions
- Asthma, Occupational
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Owlstone Ltd
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occupational Asthma | – | Device: Breath BiopsyPatients refered for assesment of occupational asthma |
| Respiratory Healthy Control | – | Device: Breath BiopsyEmployees at Oslo University Hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with occupational asthma, referred to the Unit of Environmental and Occupational medicine OUS for evaluation of OA.and healthy volunteers
Key inclusion criteria (2 listed)
- capable of informed consent.
- asthma diagnosis established by lung specialist or healthy control.
Key exclusion criteria (4 listed)
- skin allergy towards plastics or rubber.
- immunocompromised by oral medication.
- contagious respiratory disease.
- biopsy of lung parenchyma within the last 36 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breath BiopsyReCIVA breath sampler (Owlstone Medical, Cambridge, UK) | Device | Occupational Asthma, Respiratory Healthy Control |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tonje Trulssen Hildre, M.Sc. contact
Bato Hammarstrøm, MD/PhD principal investigator
Oslo University Hospital
Tonje Trulssen Hildre, M.Sc. study chair
Oslo University Hospital
Hilde Heiro, MD study chair
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, Occupational, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bato Hammarström, MD/PhD (+47 230 16667, bato.hammarstrom@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discovery of VOC Biomarkers in Asthma (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.