Nasal Provocation Testing in Occupational Rhinitis

Not Applicable

Completed

• Conditions: Allergic Rhinitis (Disorder)

• Registration Number: NCT01436851
• Lead Sponsor: Haukeland University Hospital

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.

Study Timeline

• Study Start: 2010-11-24
• Study First Submitted: 2011-08-16
• Primary Completion: 2011-09-01
• Study First Submitted QC: 2011-09-18
• Study First Posted: 2011-09-20
• Study Completion: 2014-12
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-14
• Last Update Posted: 2017-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dept. of Occupational Medicine, Haukeland University Hospital; 🇳🇴 Bergen, Norway