NCT02810535

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 31, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2017

Completed
Last Updated

November 30, 2017

Status Verified

November 1, 2017

Enrollment Period

1.3 years

First QC Date

May 31, 2016

Last Update Submit

November 29, 2017

Conditions

Perennial Rhinitis

Keywords

Local IgENon-allergic rhinitisAllergic rhinitis to house dust mite

Outcome Measures

Primary Outcomes (1)

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

    one year

Secondary Outcomes (3)

  • 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

Study Arms (3)

Allergic rhinitis

ACTIVE COMPARATOR

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

Other: Observation

Non-allergic rhinitis

EXPERIMENTAL

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

Other: Observation

Healthy Control

OTHER

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

Other: Observation

Interventions

ObservationOTHER

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

Allergic rhinitisHealthy ControlNon-allergic rhinitis

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Informed consent
  • Seasonal or all-season symptoms of an allergic or non-allergic rhinitis
  • Healthy non-allergic subjects

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goethe University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Related Publications (6)

  • 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.

    PMID: 15248853BACKGROUND

  • 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.

    PMID: 11345277BACKGROUND

  • 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.

    PMID: 25270425RESULT

  • 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.

    PMID: 25495772RESULT

  • 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.

    PMID: 49744RESULT

  • 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.

    PMID: 32612737DERIVED

MeSH Terms

Conditions

Common Cold

Interventions

Observation

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Stefan Zielen, Professor

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of pediatrics, allergy, pneumology, cystic fibrosis

Study Record Dates

First Submitted

May 31, 2016

First Posted

June 23, 2016

Study Start

May 1, 2016

Primary Completion

August 1, 2017

Study Completion

September 19, 2017

Last Updated

November 30, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)