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Nasal Provocation Testing in Occupational Rhinitis (NPT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01436851
First received: August 16, 2011
Last updated: August 14, 2017
Last verified: August 2017
  Purpose
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.

Condition Intervention
Allergic Rhinitis (Disorder) Biological: Storage mite allergen extracts

Study Type: Interventional
Study Design: 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.
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
Primary Purpose: Diagnostic
Official Title: Nasal Provocation Testing With Nasal Lavage in Allergic and Non-allergic Occupational Rhinitis

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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

  • 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

  • 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


Enrollment: 17
Actual Study Start Date: November 24, 2010
Study Completion Date: December 2014
Primary Completion Date: September 1, 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01436851

Locations
Norway
Dept. of Occupational Medicine, Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Principal Investigator: Torgeir Storaas, MD PhD Haukeland University Hospital
  More Information

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01436851     History of Changes
Other Study ID Numbers: 2009/265
Study First Received: August 16, 2011
Last Updated: August 14, 2017

Keywords provided by Haukeland University Hospital:
rhinitis
allergy
occupational
storage mites
nasal lavage
challenge test
ECP
alfa2Macroglobuline

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 21, 2017