Nasal Provocation Testing in Occupational Rhinitis (NPT)

August 14, 2017 updated by: Haukeland University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5021
        • Dept. of Occupational Medicine, Haukeland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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)
Biological: Storage mite allergen extracts
Nasal provocation with increasing doses of storage mite allergen extracts
Other Names:
  • Acarus Siro
  • Lepidoglyphus Destructor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Change from baseline to 10 minutes after nasal provocation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rhinitis symptoms after specific nasal provocation with storage mite allergen glyphus Destructor)
Time Frame: 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
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
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
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
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
Change from baseline to 10 minutes after provocation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haukeland University Hospital

Investigators

  • Principal Investigator: Torgeir Storaas, MD PhD, Haukeland University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 24, 2010

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

August 16, 2011

First Submitted That Met QC Criteria

September 18, 2011

First Posted (ESTIMATE)

September 20, 2011

Study Record Updates

Last Update Posted (ACTUAL)

August 16, 2017

Last Update Submitted That Met QC Criteria

August 14, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/265

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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