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Local IgE in Subjects With Allergic or Non-allergic Rhinitis

NCT ID: NCT02810535

Last Updated: 2017-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-09-19

Brief Summary

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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

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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.

Conditions

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Perennial Rhinitis

Keywords

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Local IgE Non-allergic rhinitis Allergic rhinitis to house dust mite

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Allergic rhinitis

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

Group Type ACTIVE_COMPARATOR

Observation

Intervention Type 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

Non-allergic rhinitis

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

Group Type EXPERIMENTAL

Observation

Intervention Type 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

Healthy Control

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

Group Type OTHER

Observation

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Stefan Zielen

Professor of pediatrics, allergy, pneumology, cystic fibrosis

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan Zielen, Professor

Role: PRINCIPAL_INVESTIGATOR

Department for children and adolescents, division of allergy, pneumology, and cystic fibrosis

Locations

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Goethe University Hospital Frankfurt

Frankfurt am Main, Hesse, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 15248853 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11345277 (View on PubMed)

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.

Reference Type RESULT
PMID: 25270425 (View on PubMed)

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.

Reference Type RESULT
PMID: 25495772 (View on PubMed)

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.

Reference Type RESULT
PMID: 49744 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32612737 (View on PubMed)

Other Identifiers

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FRA.LISA.2015

Identifier Type: -

Identifier Source: org_study_id