Local IgE in Subjects With Allergic or Non-allergic Rhinitis (LISA)

Johann Wolfgang Goethe University Hospital

Status: Completed

Conditions: Perennial Rhinitis

Treatments: Other: Observation

Study type: Interventional

Funder types: Other

Identifiers

NCT02810535

FRA.LISA.2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Informed consent
• Seasonal or all-season symptoms of an allergic or non-allergic rhinitis
• Healthy non-allergic subjects

Exclusion criteria

• Patients: Age <18 and > 45
• Other severe diseases (e.g. Cystic fibrosis, diseases with immunosuppression, malignant diseases)
• Previously occurred allergic shock
• Pregnancy and lactation
• Participation in another clinical trial within the last 30 days
• Inability to measure the length and the consequences of the study
• Frequent use of medication which could not be discontinued in the defined time before enrollment: nasal vasoconstrictors 1 day; antihistamines 3 days; nasal steroids 7 days; oral cortison 4 weeks; leukotriene antagonists and cromolyn 2 days before NPT

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups

Allergic rhinitis

Active Comparator group

Description:

Clinical observation of 24 subjects with nasal symptoms and positive prick test for house dust mite

Treatment:

Other: Observation

Non-allergic rhinitis

Experimental group

Description:

Clinical observation of 24 subjects with nasal symptoms and negative prick test for house dust mite

Treatment:

Other: Observation

Healthy Control

Other group

Description:

Clinical observation of 20 subjects without nasal symptoms and with negative prick test

Treatment:

Other: Observation