Allergic Rhinitis (Disorder)
Conditions
Keywords
rhinitis, allergy, occupational, storage mites, nasal lavage, challenge test, ECP, alfa2Macroglobuline
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALStorage mite allergen extracts
Nasal provocation with increasing doses of storage mite allergen extracts
Sponsors
Haukeland University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
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
Intervention model description
Participants with storage mite sensitization were challenged with placebo extract and storage mite extract in the nose.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* bakery workers * \> 18 years * sensitized to a storage mite (A.Siro or L. Destructor)
Exclusion criteria
* pregnant or breast-feeding * infection in upper or lower airways the last month * nasal polyposis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurements of indices of inflammation in nasal lavage after specific nasal provocation with storage mite allergen | Change from baseline to 10 minutes after nasal provocation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rhinitis symptoms after specific nasal provocation with storage mite allergen glyphus Destructor) | Change from baseline to 10 minutes after provocation | 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 |
| Reduction in nasal patency measured by peak nasal inspiratory flow meter after specific nasal provocation with storage mite allergen | Change from baseline to 10 minutes after provocation | 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 |
| Objective signs of rhinitis assessed by rhinoscopy after specific nasal provocation with storage mite allergen | Change from baseline to 10 minutes after provocation | 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 |
Countries
Norway
Outcome results
None listed