Nasal Provocation Testing in Occupational Rhinitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Nasal Provocation Testing With Nasal Lavage in Allergic and Non-allergic Occupational Rhinitis

Conditions
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Allergic Rhinitis (Disorder)

Intervention / Treatment
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* Biological: Storage mite allergen extracts


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Participants with storage mite sensitization were challenged with placebo extract and storage mite extract in the nose.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Storage mite and placebo nasal challenge<br>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) | Biological: Storage mite allergen extracts<br>* Nasal provocation with increasing doses of storage mite allergen extracts<br>* Other names: Lepidoglyphus Destructor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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storage mites, nasal lavage, ECP, rhinitis, allergy, occupational, challenge test, alfa2Macroglobuline