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Nasal Provocation Testing in Occupational Rhinitis (NPT)

Primary Purpose

Allergic Rhinitis (Disorder)

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Storage mite allergen extracts
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Allergic Rhinitis (Disorder) focused on measuring rhinitis, allergy, occupational, storage mites, nasal lavage, challenge test, ECP, alfa2Macroglobuline

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Dept. of Occupational Medicine, Haukeland University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Storage mite and placebo nasal challenge

Arm 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)

Outcomes

Primary Outcome Measures

Measurements of indices of inflammation in nasal lavage after specific nasal provocation with storage mite allergen
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

Secondary Outcome Measures

Rhinitis symptoms after specific nasal provocation with storage mite allergen glyphus Destructor)
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
Reduction in nasal patency measured by peak nasal inspiratory flow meter after specific nasal provocation with storage mite allergen
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
Objective signs of rhinitis assessed by rhinoscopy after specific nasal provocation with storage mite allergen
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

Full Information

First Posted
August 16, 2011
Last Updated
August 14, 2017
Sponsor
Haukeland University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01436851
Brief Title
Nasal Provocation Testing in Occupational Rhinitis
Acronym
NPT
Official Title
Nasal Provocation Testing With Nasal Lavage in Allergic and Non-allergic Occupational Rhinitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 24, 2010 (Actual)
Primary Completion Date
September 1, 2011 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis (Disorder)
Keywords
rhinitis, allergy, occupational, storage mites, nasal lavage, challenge test, ECP, alfa2Macroglobuline

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants with storage mite sensitization were challenged with placebo extract and storage mite extract in the nose.
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
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Storage mite and placebo nasal challenge
Arm Type
Experimental
Arm 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)
Intervention Type
Biological
Intervention Name(s)
Storage mite allergen extracts
Other Intervention Name(s)
Acarus Siro, Lepidoglyphus Destructor
Intervention Description
Nasal provocation with increasing doses of storage mite allergen extracts
Primary Outcome Measure Information:
Title
Measurements of indices of inflammation in nasal lavage after specific nasal provocation with storage mite allergen
Description
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
Time Frame
Change from baseline to 10 minutes after nasal provocation
Secondary Outcome Measure Information:
Title
Rhinitis symptoms after specific nasal provocation with storage mite allergen glyphus Destructor)
Description
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
Time Frame
Change from baseline to 10 minutes after provocation
Title
Reduction in nasal patency measured by peak nasal inspiratory flow meter after specific nasal provocation with storage mite allergen
Description
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
Time Frame
Change from baseline to 10 minutes after provocation
Title
Objective signs of rhinitis assessed by rhinoscopy after specific nasal provocation with storage mite allergen
Description
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
Time Frame
Change from baseline to 10 minutes after provocation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torgeir Storaas, MD PhD
Organizational Affiliation
Haukeland University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Occupational Medicine, Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway

12. IPD Sharing Statement

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Nasal Provocation Testing in Occupational Rhinitis

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