Nasal Provocation Testing in Occupational Rhinitis

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

Sponsors

Lead Sponsor: Haukeland University Hospital

Source 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.

Overall Status Completed
Start Date November 24, 2010
Completion Date December 2014
Primary Completion Date September 1, 2011
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Secondary Outcome
Measure Time Frame
Rhinitis symptoms after specific nasal provocation with storage mite allergen glyphus Destructor) 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 Change from baseline to 10 minutes after provocation
Objective signs of rhinitis assessed by rhinoscopy after specific nasal provocation with storage mite allergen Change from baseline to 10 minutes after provocation
Enrollment 17
Condition
Intervention

Intervention Type: Biological

Intervention Name: Storage mite allergen extracts

Description: Nasal provocation with increasing doses of storage mite allergen extracts

Arm Group Label: Storage mite and placebo nasal challenge

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Torgeir Storaas, MD PhD Principal Investigator Haukeland University Hospital
Location
Facility: Dept. of Occupational Medicine, Haukeland University Hospital
Location Countries

Norway

Verification Date

August 2017

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Storage mite and placebo nasal challenge

Type: Experimental

Description: 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)

Acronym NPT
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: Participants with storage mite sensitization were challenged with placebo extract and storage mite extract in the nose.

Primary Purpose: Diagnostic

Masking: None (Open Label)

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

Source: ClinicalTrials.gov