Local IgE in Subjects With Allergic or Non-allergic Rhinitis

Perennial Rhinitis Clinical Trial

— LISA  

Official title:

Local IgE in Subjects With Allergic or Non-allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02810535
• Other study ID #: FRA.LISA.2015
• Status: Completed
• Phase: N/A
• First received: May 31, 2016
• Last updated: November 29, 2017
• Start date: May 2016
• Est. completion date: September 19, 2017

Study information

• Verified date: November 2017
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 19, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Common Cold
• Perennial Rhinitis
• Rhinitis

Intervention

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

Locations

Country	Name	City	State
Germany	Goethe University Hospital Frankfurt	Frankfurt am Main	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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. — View 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. — View Citation

Campo P, Rondón 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. Review. — View 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. — View Citation

Litvyakova LI, Baraniuk JN. Nasal provocation testing: a review. Ann Allergy Asthma Immunol. 2001 Apr;86(4):355-64; quiz 364-5, 386. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of IgE between 24 subjects with non-allergic rhinitis, 24 subjects with allergic rhinitis and 20 healthy subjects.		one year
Secondary	Comparison of specific IgE between 24 subjects with non-allergic rhinitis, 24 subjects with allergic rhinitis and 20 healthy subjects.		one year
Secondary	Correlation between Peak Nasal Inspiratory Flow as well as the nasal symptoms in nasal provocation test and local specific IgE.		one year
Secondary	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