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Nasal Provocation Testing in Occupational Rhinitis (NPT)

H

Haukeland University Hospital

Status

Completed

Conditions

Allergic Rhinitis (Disorder)

Treatments

Biological: Storage mite allergen extracts

Study type

Interventional

Funder types

Other

Identifiers

NCT01436851
2009/265

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

17 participants in 1 patient group

Storage mite and placebo nasal challenge
Experimental group
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)
Treatment:
Biological: Storage mite allergen extracts

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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