Nasal Provocation Testing in Occupational Rhinitis

Allergic Rhinitis (Disorder) Clinical Trial

— NPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01436851
• Other study ID #: 2009/265
• Status: Completed
• Phase: N/A
• First received: August 16, 2011
• Last updated: August 14, 2017
• Start date: November 24, 2010
• Est. completion date: December 2014

Study information

• Verified date: August 2017
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2014
• Est. primary completion date: September 1, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis (Disorder)
• Rhinitis
• Rhinitis, Allergic

Intervention

Biological:
• Storage mite allergen extracts
Nasal provocation with increasing doses of storage mite allergen extracts

Locations

Country	Name	City	State
Norway	Dept. of Occupational Medicine, Haukeland University Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline to 10 minutes after nasal provocation
Secondary	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	Change from baseline to 10 minutes after provocation
Secondary	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	Change from baseline to 10 minutes after provocation
Secondary	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	Change from baseline to 10 minutes after provocation