Nasal Provocation Testing in Occupational Rhinitis

NCT01436851 | Completed

• 1 other identifier: 2009/265
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis (Disorder)

Keywords

rhinitis; allergy; occupational; storage mites; nasal lavage; challenge test; ECP; alfa2Macroglobuline

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Rhinitis symptoms after specific nasal provocation with storage mite allergen glyphus Destructor)

  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

  Change from baseline to 10 minutes after provocation

• Objective signs of rhinitis assessed by rhinoscopy after specific nasal provocation with storage mite allergen

  Change from baseline to 10 minutes after provocation

Study Arms (1)

Storage mite and placebo nasal challenge

EXPERIMENTAL

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

Interventions

Storage mite allergen extracts BIOLOGICAL

Nasal provocation with increasing doses of storage mite allergen extracts

Also known as: Acarus Siro, Lepidoglyphus Destructor

Storage mite and placebo nasal challenge

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• bakery workers
• \> 18 years
• sensitized to a storage mite (A.Siro or L. Destructor)

You may not qualify if:

• pregnant or breast-feeding
• infection in upper or lower airways the last month
• nasal polyposis

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Dept. of Occupational Medicine, Haukeland University Hospital

Bergen, 5021, Norway

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Rhinitis; Hypersensitivity

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Immune System Diseases; Respiratory Tract Infections; Infections

Study Officials

• Torgeir Storaas, MD PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants with storage mite sensitization were challenged with placebo extract and storage mite extract in the nose.

Study Record Dates

• First Submitted: August 16, 2011
• First Posted: September 20, 2011
• Study Start: November 24, 2010
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2014
• Last Updated: August 16, 2017

Record last verified: 2017-08

Locations

NO (1)