Overview

This trial is active, not recruiting.

Condition allergic rhinitis (disorder)
Treatment storage mite allergen extracts
Sponsor Haukeland University Hospital
Start date August 2011
End date September 2012
Trial size 30 participants
Trial identifier NCT01436851, 2009/265

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking single blind (subject)
Primary purpose diagnostic
Arm
(Experimental)
Provocation in the nose either with an allergen extract of a storage mite (A. Siro or L. Destructor) and placebo (physiologic salt water)
storage mite allergen extracts Acarus Siro
Nasal provocation with increasing doses of storage mite allergen extracts

Primary Outcomes

Measure
Measurements of indices of inflammation in nasal lavage after specific nasal provocation with storage mite allergen
time frame: Change from baseline to 10 minutes after nasal provocation

Secondary Outcomes

Measure
Rhinitis symptoms after specific nasal provocation with storage mite allergen glyphus Destructor)
time frame: 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
time frame: Change from baseline to 10 minutes after provocation
Objective signs of rhinitis assessed by rhinoscopy after specific nasal provocation with storage mite allergen
time frame: Change from baseline to 10 minutes after provocation

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Nasal Provocation Testing With Nasal Lavage in Allergic and Non-allergic Occupational Rhinitis
Principal investigator Torgeir Storaas, MD PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Haukeland University Hospital.