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Completed

NCT Number: NCT02810535

Local IgE in Subjects With Allergic or Non-allergic Rhinitis

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Goethe University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

observation

Other

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

Primary outcomes

  1. Comparison of IgE between 24 subjects with non-allergic rhinitis, 24 subjects with allergic rhinitis and 20 healthy subjects.

    Time frame: one year

Secondary outcomes

  1. Comparison of specific IgE between 24 subjects with non-allergic rhinitis, 24 subjects with allergic rhinitis and 20 healthy subjects.

    Time frame: one year

  2. Correlation between Peak Nasal Inspiratory Flow as well as the nasal symptoms in nasal provocation test and local specific IgE.

    Time frame: one year

  3. Explorative Measures: Comparison of the nasal and serum epitope spectrum with the new mite specific IgE component-chip in subjects with allergic rhinitis.

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Acronym: LISA

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 23, 2016
Registry last updated
Nov 30, 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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