Asthma, OccupationalSHInENCT05039229
Measures for Bioaerosol Reduction in the Salmon Industry
A study testing Nozzles (NZ) and Cleaning of surfaces (CS) in people with Asthma, Occupational and Hypersensitivity, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
Workers in the salmon industry are at risk of developing allergies and respiratory diseases, including asthma, due to occupational exposure to bioaerosols, i.e. biological agents such as allergens, enzymes and endotoxins, in their work environment. 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, Hypersensitivity
- What is being tested?
- Nozzles (NZ) and Cleaning of surfaces (CS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,113 participants
- Where
- 1 siteNorway
- Study dates
- 20 Sep 2021to 30 Jun 2023
- Phase
- Interventional
- 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
Who may be able to join
None listed.
Who cannot join
- For spirometry measurements: heart attack, operation on eyes, stomach or in the chest region in the course of the last three months, ongoing treatment for tuberculosis or other respiratory infection, pregnancy
- For skin prick tests: pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Interventions to Prevent Work-related Asthma, Allergy and Other Hypersensitivity Reactions in Norwegian Salmon Industry Workers (SHInE)
Workers in the salmon industry are at risk of developing allergies and respiratory diseases, including asthma, due to occupational exposure to bioaerosols, i.e. biological agents such as allergens, enzymes and endotoxins, in their work environment. The overall objective of this intervention trial is to identify effective and feasible control measures (interventions) that reduce exposure to these bioaerosols.
The project comprises nine salmon processing factories in northern, central and western Norway. The factories are allocated to either one of the two intervention arms or the control group. In all factories, an assessment of exposure to bioaerosols will be performed. In addition, employees will be invited to undergo a health examination and fill out a self-administered questionnaire including information on demographics, work tasks, health and health promoting factors.
Read more
The intervention trial is part of a broader study that comprises several substudies including the identification of clinically relevant allergens, investigation of exposure-response relationship between the exposure to individual bioactive agents in bioaerosols and investigations of prevalence of airway symptoms, altered lung function, skin symptoms or immunological responses indicating hypersensitivity. Finally the project includes the identification of health promoting factors that are present in the salmon processing industry.
The project is an interdisciplinary multi-center study that places great emphasis on a close dialogue between the researchers and industry in all phases of the project.
Read the detailed description
The intervention trial is part of a broader study on assessment of exposure and health of workers in the salmon industry. Measurements of exposure, health examinations and questionnaire data serve as a basis for both intervention- and other substudies.
The intervention trial itself is a parallel group, three-arm non-randomized superiority trial with a 1:1:1 allocation.
Processing of salmon includes two main processes: 1) in the slaughtering department, the fish are slaughtered, sorted, automatically or manually gutted, and washed before further processing; and 2) in the filleting department, the salmon is filleted and skinned by machines before manual trimming of the fillets. The main source of exposure to fish proteins is by inhalation of wet bioaerosols containing a heterogeneous mixture of proteins, enzymes, endotoxins and microorganisms.
It is hypothesized that a reduction in exposure will cause a decrease in the prevalence of symptoms from the airways and skin, as well as sensitization, in workers of factories that implement the exposure-reducing measures.Hence, the overall aim of identifying effective and feasible control measures (interventions) that reduce exposure to these bioaerosols is to lower the risk of, or preferably prevent, the development or chronification of respiratory diseases, eczema and allergy among salmon processing workers.
The main hypothesis behind the interventions is that control measures that aim at using less water, at reduction of bioaerosol generation or at shielding workers from the production line have the potential to reduce bioaerosol exposure. The three arms of the trial are therefore 1) technical intervention targeting alteration of nozzles or nozzle function along the production line (NZ), 2) behavioral or technical intervention related to cleaning of surfaces (CS), or 3) no intervention (control). Each of the intervention arms represents a general intervention category in which details for the actual intervention are to be developed in collaboration with the factory staff to maximize the effect of the interventions.
The intervention arms NZ and CS imply measures that have the potential to reduce bioaerosol exposure for the employees, while factories in the CTR arm will not receive any active intervention measures. NZ targets alteration of nozzles or nozzle function along the production line, e.g. by manipulation of nozzle dimensions, alteration of operating pressure or shielding of the nozzle's output stream. CS focuses on reduction of bioaerosol exposure for the employees while cleaning their personal operating areas during working operations or while cleaning floor areas . This can include increased use of swabbing instead of flushing with water hoses or alterations in use of water hoses for cleaning. Examples for the latter are a reduced flushing frequency, reduction of number of employees executing the work, alterations of hose dimension or nozzles on hoses. Suggestions from employees regarding details of the intervention will be taken into account for the final design of the intervention. This can include local specific characteristics, specific location of intervention or others.
Randomization of intervention arms is not feasible due to different premises of factory infrastructure. The nine participating factories (three from each geographical region) will therefore be allocated to the study arms by the project group, reassuring that each region will cover all three study arms.
Data assessment will be done by questionnaires, exposure measurements and health examinations before (T1) and after the intervention period (T2). Interventions will start 5-8 weeks after T1, permitting technical adjustments where necessary. Interventions are to be continued until follow-up measurements at T2, 12 months after T1. Two phone calls and one physical visit are to be carried out during the intervention period.
Questionnaire data relevant for the intervention trial include background demographics, questions relevant for exposure assessment (work tasks, department, etc), as well as questions on symptoms from the eyes, the respiratory system and skin.
Health examinations will include spirometry (lung function), skin prick testing (allergic sensitization) and blood sampling (sensitization, inflammation). Exposure assessment will be done by personal exposure measurements collected in the breathing zone of workers, as well as by stationary sampling.
While all workers (approx. 1500-2000 subjects), will be eligible for answering the questionnaires, the number of invitees for health examination and exposure assessments will be much lower (ca 900 and 216, respectively), due to logistical and timely constraints.
Sample size calculations was performed for the primary outcome; the effect of interventions in reducing the concentration of bioaerosols (total protein) in salmon processing plants. The inclusion of 24 workers with 2 repeated measurements in each of the three intervention arms (see section on inclusion criteria above) will give a total of 432 measurements (144 measurements in each of the intervention arms). According to the sample size calculations, 133 exposure measurements of total proteins in each of the intervention arms give a power of 80% of detecting a 20% reduction of exposure (significance level of 0.05). The corresponding number of measurements needed to detect a reduction in exposure of 40 and 30% were 34 and 59 measurements, respectively. Hence, 144 measurements as aimed at in the present study will ensure a buffer of about 8% in order to account for rejection of measurements due to sampling errors. The number of exposure measurements per work shift will also be limited by logistical constraints.
- Conditions
- Asthma, Occupational, Hypersensitivity
- Being tested
- Nozzles (NZ), Cleaning of surfaces (CS)
- Medical subject headings
- Asthma, Occupational, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nozzles (NZ)Other
Technical intervention targeting alteration of nozzles or nozzle function along the production line, e.g. by manipulation of nozzle dimensions, alteration of operating pressure or shielding of the nozzle's output stream. How the intervention is to be carried out in detail in the respective factory is to be developed in collaboration with the factory staff. This can include local specific characteristics, specific location of intervention or others.
Cleaning of surfaces (CS)Other
Behavioural or technical intervention. This can include increased use of swabbing instead of flushing with water hoses or alterations in use of water hoses for cleaning. Examples for the latter are a reduced flushing frequency, reduction of number of employees executing the work, alterations of hose dimension or nozzles on hoses. How the intervention is to be carried out in detail in the respective factory is to be developed in collaboration with the factory staff. This can include local specific characteristics, specific location of intervention or others.
| Study group | Role | What they receive |
|---|---|---|
| Nozzles (NZ) | Experimental | Intervention with the aim of reducing bioaerosol exposure for the employees, targeting alteration of nozzles or nozzle function along the production line. Receives: Other: Nozzles (NZ) |
| Cleaning of surfaces (CS) | Experimental | Intervention with the aim of reducing bioaerosol exposure for the employees while cleaning their personal operating areas (work benches and part of production lines) during work operations or while cleaning floor areas. Receives: Other: Cleaning of surfaces (CS) |
| Control (CTR) | No intervention | Work is to be carried out as usual without any intervention measures. Follow-up according to the same schedule as for the other intervention groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of salmon processing workers' personal exposure to inhalable protein
Change in inhalable total protein (ug/m3) in the workers' breathing zone from pre-intervention (baseline, T1) to post-intervention (follow-up, T2). Differences in mean concentration of full shift measurements (8 hours) between intervention groups and between intervention groups and control group will be analyzed.
Measured: Measurements at T1 compared to T2, 12 months after T1.
Secondary outcomes (13)
Change of salmon processing workers' personal exposure to proteases
Change in concentration of proteases (ng/m3) in the workers' breathing zone from pre-intervention (baseline, T1) to post-intervention (follow-up, T2). Differences in mean concentration of full shift measurements (8 hours) between intervention groups and between intervention groups and control group will be analyzed.
Measured: Measurements at T1 compared to T2, 12 months after T1.
Change in area concentration of airborne total protein (stationary measurements)
Change in total protein (ug/m3, inhalable aerosol fraction) from stationary measurements in relevant areas of the salmon production line from pre-intervention (baseline, T1) to post-intervention (follow-up, T2). Differences in mean concentration of full shift measurements (8 hours) between intervention groups and between intervention groups and control group will be analyzed.
Measured: Measurements at T1 compared to T2, 12 months after T1.
Change of salmon processing workers' personal exposure to airborne fish allergens
Change in concentration of total aerosol fraction of fish allergens (ng/m3) in the workers' breathing zone from pre-intervention (baseline, T1) to post-intervention (follow-up, T2). Differences in mean concentration of full shift measurements (8 hours) between intervention groups and between intervention groups and control group will be analyzed.
Measured: Measurements at T1 compared to T2, 12 months after T1.
Change of salmon processing workers' personal exposure to airborne endotoxins
Change in mean concentration of inhalable total endotoxin units (EU/m3) in the workers' breathing zone from pre-intervention (baseline, T1) to post-intervention (follow-up, T2). Differences in mean concentration of full shift measurements (8 hours) between intervention groups and between intervention groups and control group will be analyzed.
Measured: Measurements at T1 compared to T2, 12 months after T1.
Change in salmon processing workers' self-reported symptoms from the upper airways
Since the investigators expect to have a significant "loss to follow-up" from T1 to T2,the investigators will analyze change in prevalence of self-reported symptoms from the nose from pre-intervention (baseline, T1) to post-intervention (follow-up, T2). Prevalence of symptoms from the respiratory system will be assessed using information reported by participants through a questionnaire that includes standardized questions on respiratory symptoms (upper and lower airways), allergic status and malaise (European Community Respiratory Health Survey, ECRHS). Differences between intervention groups and between intervention groups and control group will be analyzed.
Measured: Data collected at T1 compared to T2, 12 months after T1.
Change in salmon processing workers' self-reported symptoms from the lower airways
Since the investigators expect to have a significant "loss to follow-up" from T1 to T2, the investigators will analyze change in prevalence of self-reported symptoms from the chest from pre-intervention (baseline, T1) to post-intervention (follow-up, T2). Prevalence of symptoms from the respiratory system, as well as the asthma symptom score (0-5) will be assessed using information reported by participants through a questionnaire that includes standardized questions on respiratory symptoms (upper and lower airways), allergic status and malaise (European Community Respiratory Health Survey, ECRHS). Differences between intervention groups and between intervention groups and control group will be analyzed.
Measured: Data collected at T1 compared to T2, 12 months after T1.
Change in salmon processing workers' self-reported eye symptoms
Since the investigators expect to have a significant "loss to follow-up" from T1 to T2, the investigators will analyze change in prevalence of self-reported symptoms from the eye pre-intervention (baseline, T1) to post-intervention (follow-up, T2). Prevalence of eye symptoms will be assessed using information reported by participants through the a set of standardized questions in a questionnaire.Differences between intervention groups and between intervention groups and control group will be analyzed.
Measured: Data collected at T1 compared to T2, 12 months after T1.
Change in salmon processing workers' lung function at group level (FEV1 in % of predicted)
Change in proportion of participants having a decline in maximum forced expired volume in 1 second (FEV1 in % of predicted), from pre-intervention (baseline, T1) to post-intervention (follow-up, T2). Differences between intervention groups and between intervention groups and control group will be analyzed.
Measured: Measurements at T1 compared to T2, 12 months after T1.
Change in salmon processing workers' lung function at individual level (maximum forced expired volume in 1 second (FEV1)/forced vital capacity (FVC) ratio)
Mean of individual change in maximum forced expired volume in 1 second (FEV1) in % of forced vital capacity (FEV1/FVC ratio), from pre-intervention (baseline, T1) to post-intervention (follow-up, T2) for individuals, provided low loss-to follow up. Differences between intervention groups and between intervention groups and control group will be analyzed.
Measured: Data collected at T1 compared to T2, 12 months after T1.
Change in salmon processing workers' cross-shift lung function (FEV1)
Change in mean difference between pre-shift values and post-shift values (cross-shift) in maximum forced expired volume in 1 second (FEV1, in liter and % of predicted) of individual salmon processing workers from pre-intervention (baseline, T1) to post-intervention (follow-up, T2) .Differences between intervention groups and between intervention groups and control group will be analyzed.
Measured: Measurements at T1 compared to T2, 12 months after T1.
Change in salmon processing workers' cross-week lung function (FEV1)
Change in mean difference between pre-shift values on Monday and post-shift values on Thursday (cross-week) in maximum forced expired volume in 1 second (FEV1, in liter and % of predicted) of individual salmon processing workers from pre-intervention (baseline, T1) to post-intervention (follow-up, T2) .Differences between intervention groups and between intervention groups and control group will be analyzed.
Measured: Measurements at T1 compared to T2, 12 months after T1.
Incidence of salmon processing workers' sensitization to salmon
Registration of number of salmon workers that are newly sensitized to salmon at follow-up. Sensitization will be assessed by serum immunoglobulin E (IgE) specific to salmon proteins. Individuals that are negative for specific immunoglobulin E (IgE) at pre-intervention (baseline, T1) and positive at post-intervention (follow-up (T2) will be registered as an incidence case. Differences between intervention groups and between intervention groups and control group will be analyzed.
Measured: Measurements at T1 compared to T2, 12 months after T1.
Change in salmon processing workers' self-reported skin symptoms
Since the investigators expect to have a significant "loss to follow-up" from T1 to T2, the investigators will analyze change in prevalence of self-reported skin symptoms from pre-intervention (baseline, T1) to post-intervention (follow-up, T2). Skin symptoms will be assessed using information from a questionnaire that includes standardized questions on eczema, other symptoms from the skin and urticaria (Nordic Occupational Skin Questionnaire, The Nordic Occupational Skin Questionnaire NOSQ-2002). Differences between intervention groups and between intervention groups and control group will be analyzed.
Measured: Data collected at T1 compared to T2, 12 months after T1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start20 Sep 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma, OccupationalStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, UiT The Arctic University of Norway, Haukeland University Hospital, University of Bergen, St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- ANJE Höper, PhD, Principal investigator, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039229
- Sponsor's protocol ID
- 131052/13118
- Acronym
- SHInE
- Status last verified
- May 2026
- First submitted
- 6 Sep 2021
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual Participant Data (IPD)-sharing will be restricted due to sensitive health data. Where possible, de-identified data will be made available after the end of the project period for researchers whose aim is to increase knowledge in the field of allergy, hypersensitivity and/or occupational health. A data handling group comprising at least one representative from each location will consider written applications from external researchers before possibly releasing individual data. More details regarding criteria for applications and which data will be made available is under preparation.
Publications
Hoper AC, Kirkeleit J, Thomassen MR, Irgens-Hansen K, Hollund BE, Fagernaes CF, Svedahl SR, Eriksen TE, Grgic M, Bang BE. Effects of Interventions to Prevent Work-Related Asthma, Allergy, and Other Hypersensitivity Reactions in Norwegian Salmon Industry Workers (SHInE): Protocol for a Pragmatic Allocated Intervention Trial and Related Substudies. JMIR Res Protoc. 2023 Jul 19;12:e48790. doi: 10.2196/48790.
PubMed 37467018
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Interventions to Prevent Work-related Asthma, Allergy and Other Hypersensitivity Reactions in Norwegian Salmon Industry Workers (SHInE)
- ClinicalTrials.gov ID
- NCT05039229
- Acronym / sponsor ID
- SHInE / 131052/13118
- Conditions
- Asthma, Occupational, Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,113 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- The Research Council of Norway, UiT The Arctic University of Norway, Haukeland University Hospital, University of Bergen, St. Olavs Hospital
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 9 Sep 2021 (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.
Workers in the salmon industry are at risk of developing allergies and respiratory diseases, including asthma, due to occupational exposure to bioaerosols, i.e. biological agents such as allergens, enzymes and endotoxins, in their work environment. The overall objective of this intervention trial is to identify effective and feasible control measures (interventions) that reduce exposure to these bioaerosols.
The project comprises nine salmon processing factories in northern, central and western Norway. The factories are allocated to either one of the two intervention arms or the control group. In all factories, an assessment of exposure to bioaerosols will be performed. In addition, employees will be invited to undergo a health examination and fill out a self-administered questionnaire including information on demographics, work tasks, health and health promoting factors.
The intervention trial is part of a broader study that comprises several substudies including the identification of clinically relevant allergens, investigation of exposure-response relationship between the exposure to individual bioactive agents in bioaerosols and investigations of prevalence of airway symptoms, altered lung function, skin symptoms or immunological responses indicating hypersensitivity. Finally the project includes the identification of health promoting factors that are present in the salmon processing industry.
The project is an interdisciplinary multi-center study that places great emphasis on a close dialogue between the researchers and industry in all phases of the project.
Detailed description
The intervention trial is part of a broader study on assessment of exposure and health of workers in the salmon industry. Measurements of exposure, health examinations and questionnaire data serve as a basis for both intervention- and other substudies.
The intervention trial itself is a parallel group, three-arm non-randomized superiority trial with a 1:1:1 allocation.
Processing of salmon includes two main processes: 1) in the slaughtering department, the fish are slaughtered, sorted, automatically or manually gutted, and washed before further processing; and 2) in the filleting department, the salmon is filleted and skinned by machines before manual trimming of the fillets. The main source of exposure to fish proteins is by inhalation of wet bioaerosols containing a heterogeneous mixture of proteins, enzymes, endotoxins and microorganisms.
It is hypothesized that a reduction in exposure will cause a decrease in the prevalence of symptoms from the airways and skin, as well as sensitization, in workers of factories that implement the exposure-reducing measures.Hence, the overall aim of identifying effective and feasible control measures (interventions) that reduce exposure to these bioaerosols is to lower the risk of, or preferably prevent, the development or chronification of respiratory diseases, eczema and allergy among salmon processing workers.
The main hypothesis behind the interventions is that control measures that aim at using less water, at reduction of bioaerosol generation or at shielding workers from the production line have the potential to reduce bioaerosol exposure. The three arms of the trial are therefore 1) technical intervention targeting alteration of nozzles or nozzle function along the production line (NZ), 2) behavioral or technical intervention related to cleaning of surfaces (CS), or 3) no intervention (control). Each of the intervention arms represents a general intervention category in which details for the actual intervention are to be developed in collaboration with the factory staff to maximize the effect of the interventions.
The intervention arms NZ and CS imply measures that have the potential to reduce bioaerosol exposure for the employees, while factories in the CTR arm will not receive any active intervention measures. NZ targets alteration of nozzles or nozzle function along the production line, e.g. by manipulation of nozzle dimensions, alteration of operating pressure or shielding of the nozzle's output stream. CS focuses on reduction of bioaerosol exposure for the employees while cleaning their personal operating areas during working operations or while cleaning floor areas . This can include increased use of swabbing instead of flushing with water hoses or alterations in use of water hoses for cleaning. Examples for the latter are a reduced flushing frequency, reduction of number of employees executing the work, alterations of hose dimension or nozzles on hoses. Suggestions from employees regarding details of the intervention will be taken into account for the final design of the intervention. This can include local specific characteristics, specific location of intervention or others.
Randomization of intervention arms is not feasible due to different premises of factory infrastructure. The nine participating factories (three from each geographical region) will therefore be allocated to the study arms by the project group, reassuring that each region will cover all three study arms.
Data assessment will be done by questionnaires, exposure measurements and health examinations before (T1) and after the intervention period (T2). Interventions will start 5-8 weeks after T1, permitting technical adjustments where necessary. Interventions are to be continued until follow-up measurements at T2, 12 months after T1. Two phone calls and one physical visit are to be carried out during the intervention period.
Questionnaire data relevant for the intervention trial include background demographics, questions relevant for exposure assessment (work tasks, department, etc), as well as questions on symptoms from the eyes, the respiratory system and skin.
Health examinations will include spirometry (lung function), skin prick testing (allergic sensitization) and blood sampling (sensitization, inflammation). Exposure assessment will be done by personal exposure measurements collected in the breathing zone of workers, as well as by stationary sampling.
While all workers (approx. 1500-2000 subjects), will be eligible for answering the questionnaires, the number of invitees for health examination and exposure assessments will be much lower (ca 900 and 216, respectively), due to logistical and timely constraints.
Sample size calculations was performed for the primary outcome; the effect of interventions in reducing the concentration of bioaerosols (total protein) in salmon processing plants. The inclusion of 24 workers with 2 repeated measurements in each of the three intervention arms (see section on inclusion criteria above) will give a total of 432 measurements (144 measurements in each of the intervention arms). According to the sample size calculations, 133 exposure measurements of total proteins in each of the intervention arms give a power of 80% of detecting a 20% reduction of exposure (significance level of 0.05). The corresponding number of measurements needed to detect a reduction in exposure of 40 and 30% were 34 and 59 measurements, respectively. Hence, 144 measurements as aimed at in the present study will ensure a buffer of about 8% in order to account for rejection of measurements due to sampling errors. The number of exposure measurements per work shift will also be limited by logistical constraints.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nozzles (NZ) | Experimental | Other: Nozzles (NZ)Intervention with the aim of reducing bioaerosol exposure for the employees, targeting alteration of nozzles or nozzle function along the production line. |
| Cleaning of surfaces (CS) | Experimental | Other: Cleaning of surfaces (CS)Intervention with the aim of reducing bioaerosol exposure for the employees while cleaning their personal operating areas (work benches and part of production lines) during work operations or while cleaning floor areas. |
| Control (CTR) | No intervention | –Work is to be carried out as usual without any intervention measures. Follow-up according to the same schedule as for the other intervention groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- For spirometry measurements: heart attack, operation on eyes, stomach or in the chest region in the course of the last three months, ongoing treatment for tuberculosis or other respiratory infection, pregnancy
- For skin prick tests: pregnancy
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 |
|---|---|---|
| Nozzles (NZ)Technical intervention targeting alteration of nozzles or nozzle function along the production line, e.g. by manipulation of nozzle dimensions, alteration of operating pressure or shielding of the nozzle's output stream. How the intervention is to be carried out in detail in the respective factory is to be developed in collaboration with the factory staff. This can include local specific characteristics, specific location of intervention or others. | Other | Nozzles (NZ) |
| Cleaning of surfaces (CS)Behavioural or technical intervention. This can include increased use of swabbing instead of flushing with water hoses or alterations in use of water hoses for cleaning. Examples for the latter are a reduced flushing frequency, reduction of number of employees executing the work, alterations of hose dimension or nozzles on hoses. How the intervention is to be carried out in detail in the respective factory is to be developed in collaboration with the factory staff. This can include local specific characteristics, specific location of intervention or others. | Other | Cleaning of surfaces (CS) |
Primary outcome
Change of salmon processing workers' personal exposure to inhalable protein
Time frame: Measurements at T1 compared to T2, 12 months after T1.
Change in inhalable total protein (ug/m3) in the workers' breathing zone from pre-intervention (baseline, T1) to post-intervention (follow-up, T2). Differences in mean concentration of full shift measurements (8 hours) between intervention groups and between intervention groups and control group will be analyzed.
13 secondary outcomes
Change of salmon processing workers' personal exposure to proteases
Time frame: Measurements at T1 compared to T2, 12 months after T1.
Change in area concentration of airborne total protein (stationary measurements)
Time frame: Measurements at T1 compared to T2, 12 months after T1.
Change of salmon processing workers' personal exposure to airborne fish allergens
Time frame: Measurements at T1 compared to T2, 12 months after T1.
Change of salmon processing workers' personal exposure to airborne endotoxins
Time frame: Measurements at T1 compared to T2, 12 months after T1.
Change in salmon processing workers' self-reported symptoms from the upper airways
Time frame: Data collected at T1 compared to T2, 12 months after T1.
Change in salmon processing workers' self-reported symptoms from the lower airways
Time frame: Data collected at T1 compared to T2, 12 months after T1.
Change in salmon processing workers' self-reported eye symptoms
Time frame: Data collected at T1 compared to T2, 12 months after T1.
Change in salmon processing workers' lung function at group level (FEV1 in % of predicted)
Time frame: Measurements at T1 compared to T2, 12 months after T1.
Change in salmon processing workers' lung function at individual level (maximum forced expired volume in 1 second (FEV1)/forced vital capacity (FVC) ratio)
Time frame: Data collected at T1 compared to T2, 12 months after T1.
Change in salmon processing workers' cross-shift lung function (FEV1)
Time frame: Measurements at T1 compared to T2, 12 months after T1.
Change in salmon processing workers' cross-week lung function (FEV1)
Time frame: Measurements at T1 compared to T2, 12 months after T1.
Incidence of salmon processing workers' sensitization to salmon
Time frame: Measurements at T1 compared to T2, 12 months after T1.
Change in salmon processing workers' self-reported skin symptoms
Time frame: Data collected at T1 compared to T2, 12 months after T1.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 37467018Hoper AC, Kirkeleit J, Thomassen MR, Irgens-Hansen K, Hollund BE, Fagernaes CF, Svedahl SR, Eriksen TE, Grgic M, Bang BE. Effects of Interventions to Prevent Work-Related Asthma, Allergy, and Other Hypersensitivity Reactions in Norwegian Salmon Industry Workers (SHInE): Protocol for a Pragmatic Allocated Intervention Trial and Related Substudies. JMIR Res Protoc. 2023 Jul 19;12:e48790. doi: 10.2196/48790.
- Individual participant dataSharing planned: Undecided. Individual Participant Data (IPD)-sharing will be restricted due to sensitive health data. Where possible, de-identified data will be made available after the end of the project period for researchers whose aim is to increase knowledge in the field of allergy, hypersensitivity and/or occupational health. A data handling group comprising at least one representative from each location will consider written applications from external researchers before possibly releasing individual data. More details regarding criteria for applications and which data will be made available is under preparation.
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.
ANJE Höper, PhD principal investigator
University Hospital of North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nozzles (NZ) and Cleaning of surfaces (CS) in people with Asthma, Occupational and Hypersensitivity, run by University Hospital of North Norway 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 0 inclusion and 2 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: finished, as of the sponsor's last update on 15 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of salmon processing workers' personal exposure to inhalable protein (time frame: Measurements at T1 compared to T2, 12 months after T1.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05039229, which also lists 1 linked publication.
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 15 May 2026.