Perennial Rhinitis
Conditions
Keywords
Local IgE, Non-allergic rhinitis, Allergic rhinitis to house dust mite
Brief 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.
Interventions
OTHERObservation
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
Sponsors
Johann Wolfgang Goethe University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of IgE between 24 subjects with non-allergic rhinitis, 24 subjects with allergic rhinitis and 20 healthy subjects. | one year |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of specific IgE between 24 subjects with non-allergic rhinitis, 24 subjects with allergic rhinitis and 20 healthy subjects. | one year |
| Correlation between Peak Nasal Inspiratory Flow as well as the nasal symptoms in nasal provocation test and local specific IgE. | one year |
| Explorative Measures: Comparison of the nasal and serum epitope spectrum with the new mite specific IgE component-chip in subjects with allergic rhinitis. | one year |
Countries
Germany
Outcome results
None listed