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

November 29, 2017 updated by: Stefan Zielen, Johann Wolfgang Goethe University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60590
        • Goethe University Hospital Frankfurt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Allergic rhinitis
Clinical observation of 24 subjects with nasal symptoms and positive prick test for house dust mite
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
Experimental: Non-allergic rhinitis
Clinical observation of 24 subjects with nasal symptoms and negative prick test for house dust mite
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
Other: Healthy Control
Clinical observation of 20 subjects without nasal symptoms and with negative prick test
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of IgE between 24 subjects with non-allergic rhinitis, 24 subjects with allergic rhinitis and 20 healthy subjects.
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of specific IgE between 24 subjects with non-allergic rhinitis, 24 subjects with allergic rhinitis and 20 healthy subjects.
Time Frame: one year
one year
Correlation between Peak Nasal Inspiratory Flow as well as the nasal symptoms in nasal provocation test and local specific IgE.
Time Frame: one year
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.
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Investigators

  • Principal Investigator: Stefan Zielen, Professor, Department for children and adolescents, division of allergy, pneumology, and cystic fibrosis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

September 19, 2017

Study Registration Dates

First Submitted

May 31, 2016

First Submitted That Met QC Criteria

June 20, 2016

First Posted (Estimate)

June 23, 2016

Study Record Updates

Last Update Posted (Actual)

November 30, 2017

Last Update Submitted That Met QC Criteria

November 29, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRA.LISA.2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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