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In a previous study the investigators found that many bakery workers were sensitized to storage mites, and many had rhinitis symptoms. The role of storage mites as an occupational allergen with clinical relevance has been questioned, and the investigators wanted to investigate whether a nasal provocation with a storage mite extract would trigger symptoms and objective signs of rhinitis in bakery workers and a control group.
The investigations include allergy testing with skin prick testing, and measuring of specific Immunoglobulin E (IgE) in sera, answering a questionnaire, and symptom scoring before and after provocations. The participants will be investigated one day with a placebo, and another day with the allergen extract of either Acarus Siro or Lepidoglyphus Destructor. As a measurement of nasal patency we use the nasal peak inspiratory flow meter, but also clinical scoring of nasal secretion and blockage. Indices of inflammation (ECP and alfa-Macroglobulin) will be monitored in nasal lavage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Storage mite and placebo nasal challenge | Experimental | Provocation in the nose with an allergen extract of a storage mite (A. Siro or L. Destructor) and with placebo allergen extract (physiologic salt water) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Storage mite allergen extracts | Biological | Nasal provocation with increasing doses of storage mite allergen extracts |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurements of indices of inflammation in nasal lavage after specific nasal provocation with storage mite allergen | Indices of inflammation (alfa2-macroglobulin, eosinophil cationic protein) in nasal lavage after specific nasal provocation with storage mite allergen (Acarus Siro or Lepidoglyphus Destructor) twice, the second provocation with doubled allergen concentration | Change from baseline to 10 minutes after nasal provocation |
| Measure | Description | Time Frame |
|---|---|---|
| Rhinitis symptoms after specific nasal provocation with storage mite allergen glyphus Destructor) | Rhinitis symptoms measured by symptoms score and visual analog scale, before and after specific nasal provocation with storage mite allergen (Acarus Siro, Lepidoglyphus Destructor) twice, the second time with doubled concentration of allergen | Change from baseline to 10 minutes after provocation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Torgeir Storaas, MD PhD | Haukeland University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Occupational Medicine, Haukeland University Hospital | Bergen | 5021 | Norway |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
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Participants with storage mite sensitization were challenged with placebo extract and storage mite extract in the nose.
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The participants were challenged on two occasions, one with placebo extract, and the other with storage mite extract, but in random order, and without the participants knowing when they received allergen or placebo
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| Reduction in nasal patency measured by peak nasal inspiratory flow meter after specific nasal provocation with storage mite allergen | Reduction in nasal patency measured by peak nasal inspiratory flow meter before and after specific nasal provocation with storage mite allergen (Acarus Siro, Lepidoglyphus Destructor) twice, the second time with doubled concentration of allergen | Change from baseline to 10 minutes after provocation |
| Objective signs of rhinitis assessed by rhinoscopy after specific nasal provocation with storage mite allergen | Objective signs of rhinitis assessed by anterior rhinoscopy, and notified as a clinical score before and after specific nasal provocation with storage mite allergen (Acarus Siro, Lepidoglyphus Destructor) twice, second time with the doubled allergen concentration | Change from baseline to 10 minutes after provocation |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |