Nasal Provocation Testing in Occupational Rhinitis

NCT ID: NCT01436851

Last Updated: 2017-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-24

Study Completion Date

2014-12-31

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.

Conditions

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Allergic Rhinitis (Disorder)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Participants with storage mite sensitization were challenged with placebo extract and storage mite extract in the nose.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

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

Study Groups

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Storage mite and placebo nasal challenge

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)

Group Type EXPERIMENTAL

Storage mite allergen extracts

Intervention Type BIOLOGICAL

Nasal provocation with increasing doses of storage mite allergen extracts

Interventions

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Storage mite allergen extracts

Nasal provocation with increasing doses of storage mite allergen extracts

Intervention Type BIOLOGICAL

Other Intervention Names

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Acarus Siro Lepidoglyphus Destructor

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Torgeir Storaas, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

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Dept. of Occupational Medicine, Haukeland University Hospital

Bergen, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2009/265

Identifier Type: -

Identifier Source: org_study_id

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