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Completed

NCT Number: NCT01436851

Nasal Provocation Testing in 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.

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Key information

Conditions

Allergic Rhinitis (Disorder) Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Rhinitis, Allergic

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Occupational Medicine, Haukeland University Hospital

Bergen, 5021, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Storage mite allergen extracts

Biological

Nasal provocation with increasing doses of storage mite allergen extracts

Other names: Acarus Siro, Lepidoglyphus Destructor

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Official study title

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

Acronym: NPT

Important dates

Study start
2010
Primary completion
2011
Study completion
2014
First posted
Sep 20, 2011
Registry last updated
Aug 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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