NCT02810535

Local IgE in Subjects With Allergic or Non-allergic Rhinitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Johann Wolfgang Goethe University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to investigate the incidence of non-allergic rhinitis on a not selected group of young students (n=100-300). Students will be selected by public posting. In all students an allergy skin test will be performed. Then the local IgE of 24 subjects with non-allergic rhinitis will be compared to the local IgE of 24 subjects with allergic rhinitis and positive prick test to house dust mite. In addition 20 controlls will be investigated. Based on these investigations, the importance of local IgE and the IgE spectrum in conjunction with rhinitis should be further clarified.

Detailed description

20% of Germans suffer from seasonal or all-season rhinitis. Despite typical allergic symptoms, in a part of the affected patients (about 10-20%) an allergy cannot be found on skin prick test or blood. Therefore, the planned trial will investigate the incidence of allergic and non-allergic rhinitis in a non selected group of young students (n=100-300). The hypothesis postulates that in test subjects with non-allergic rhinitis the allergy can only be proven locally in nasal secretion. From the initial large cohort of patients, 24 subjects with house dust mite allergy and allergic rhinitis and 24 patients with non-allergic rhinitis will be selected and investigated in more detail at a second visit. At the second visit, blood and nasal secretion (measurement of local IgE) will be taken from all pre-selected 48 patients. At visit 2 a nasal provocation test with house dust mite allergen will be performed in all patients to compare nasal symptoms with the results of local IgE between patient groups. In addition the same investigations will be performed in a group of 20 healthy non-allergic subjects.

Conditions

• Perennial Rhinitis

Interventions

Type	Name	Description
OTHER	Observation	Visit 1: * Physical examination (inspection of nasopharynx, auscultation of heart and lungs) * Completion of a Health Questionnaire * Lung function testing with spirometry * Skin prick test Visit 2: * Physical examination (inspection of nasopharynx, auscultation of heart and lungs) * Measurement of nitric oxide in expired air (FeNO) * Taking nasal secretion samples with a cotton carrier for 15 min * Nasal provocation test with dust mite * Blood sample collection to define blood count, IgE and specific IgE

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-08-01
• Completion: 2017-09-19
• First posted: 2016-06-23
• Last updated: 2017-11-30

Locations

1 site across 1 country: Germany