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

Primary Purpose

Perennial Rhinitis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Observation
Sponsored by
Johann Wolfgang Goethe University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Perennial Rhinitis focused on measuring Local IgE, Non-allergic rhinitis, Allergic rhinitis to house dust mite

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Goethe University Hospital Frankfurt

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Other

Arm Label

Allergic rhinitis

Non-allergic rhinitis

Healthy Control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Comparison of specific IgE between 24 subjects with non-allergic rhinitis, 24 subjects with allergic rhinitis and 20 healthy subjects.
Correlation between Peak Nasal Inspiratory Flow as well as the nasal symptoms in nasal provocation test and local specific IgE.
Explorative Measures: Comparison of the nasal and serum epitope spectrum with the new mite specific IgE component-chip in subjects with allergic rhinitis.

Full Information

First Posted
May 31, 2016
Last Updated
November 29, 2017
Sponsor
Johann Wolfgang Goethe University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02810535
Brief Title
Local IgE in Subjects With Allergic or Non-allergic Rhinitis
Acronym
LISA
Official Title
Local IgE in Subjects With Allergic or Non-allergic Rhinitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
September 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johann Wolfgang Goethe University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perennial Rhinitis
Keywords
Local IgE, Non-allergic rhinitis, Allergic rhinitis to house dust mite

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Allergic rhinitis
Arm Type
Active Comparator
Arm Description
Clinical observation of 24 subjects with nasal symptoms and positive prick test for house dust mite
Arm Title
Non-allergic rhinitis
Arm Type
Experimental
Arm Description
Clinical observation of 24 subjects with nasal symptoms and negative prick test for house dust mite
Arm Title
Healthy Control
Arm Type
Other
Arm Description
Clinical observation of 20 subjects without nasal symptoms and with negative prick test
Intervention Type
Other
Intervention Name(s)
Observation
Intervention Description
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 Outcome Measure Information:
Title
Comparison of IgE between 24 subjects with non-allergic rhinitis, 24 subjects with allergic rhinitis and 20 healthy subjects.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Comparison of specific IgE between 24 subjects with non-allergic rhinitis, 24 subjects with allergic rhinitis and 20 healthy subjects.
Time Frame
one year
Title
Correlation between Peak Nasal Inspiratory Flow as well as the nasal symptoms in nasal provocation test and local specific IgE.
Time Frame
one year
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Zielen, Professor
Organizational Affiliation
Department for children and adolescents, division of allergy, pneumology, and cystic fibrosis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Goethe University Hospital Frankfurt
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15248853
Citation
Bez C, Schubert R, Kopp M, Ersfeld Y, Rosewich M, Kuehr J, Kamin W, Berg AV, Wahu U, Zielen S. Effect of anti-immunoglobulin E on nasal inflammation in patients with seasonal allergic rhinoconjunctivitis. Clin Exp Allergy. 2004 Jul;34(7):1079-85. doi: 10.1111/j.1365-2222.2004.01998.x.
Results Reference
background
PubMed Identifier
11345277
Citation
Litvyakova LI, Baraniuk JN. Nasal provocation testing: a review. Ann Allergy Asthma Immunol. 2001 Apr;86(4):355-64; quiz 364-5, 386. doi: 10.1016/S1081-1206(10)62478-7.
Results Reference
background
PubMed Identifier
25270425
Citation
Buslau A, Voss S, Herrmann E, Schubert R, Zielen S, Schulze J. Can we predict allergen-induced asthma in patients with allergic rhinitis? Clin Exp Allergy. 2014 Dec;44(12):1494-502. doi: 10.1111/cea.12427.
Results Reference
result
PubMed Identifier
25495772
Citation
Campo P, Rondon C, Gould HJ, Barrionuevo E, Gevaert P, Blanca M. Local IgE in non-allergic rhinitis. Clin Exp Allergy. 2015 May;45(5):872-881. doi: 10.1111/cea.12476.
Results Reference
result
PubMed Identifier
49744
Citation
Huggins KG, Brostoff J. Local production of specific IgE antibodies in allergic-rhinitis patients with negative skin tests. Lancet. 1975 Jul 26;2(7926):148-50. doi: 10.1016/s0140-6736(75)90056-2.
Results Reference
result
PubMed Identifier
32612737
Citation
Eckrich J, Hinkel J, Fischl A, Herrmann E, Holtappels G, Bachert C, Zielen S. Nasal IgE in subjects with allergic and non-allergic rhinitis. World Allergy Organ J. 2020 Jun 23;13(6):100129. doi: 10.1016/j.waojou.2020.100129. eCollection 2020 Jun.
Results Reference
derived

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Local IgE in Subjects With Allergic or Non-allergic Rhinitis

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