Clinical trial NCT01436851: Nasal Provocation Testing in Occupational Rhinitis
Official title: Nasal Provocation Testing With Nasal Lavage in Allergic and Non-allergic Occupational Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Rhinitis (Disorder)
Keywords: rhinitis
allergy
occupational
storage mites
nasal lavage
challenge test
ECP
alfa2Macroglobuline
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2011-09-20
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants with storage mite sensitization were challenged with placebo extract and storage mite extract in the nose.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measurements of indices of inflammation in nasal lavage after specific nasal provocation with storage mite allergen
timeFrame: Change from baseline to 10 minutes after nasal provocation
Secondary outcomes:
measure: Rhinitis symptoms after specific nasal provocation with storage mite allergen glyphus Destructor)
timeFrame: Change from baseline to 10 minutes after provocation
measure: Reduction in nasal patency measured by peak nasal inspiratory flow meter after specific nasal provocation with storage mite allergen
timeFrame: Change from baseline to 10 minutes after provocation
measure: Objective signs of rhinitis assessed by rhinoscopy after specific nasal provocation with storage mite allergen
timeFrame: Change from baseline to 10 minutes after provocation
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Dept. of Occupational Medicine, Haukeland University Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Torgeir Storaas, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: