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Trial record 71 of 248 for:    test AND provocation

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

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ClinicalTrials.gov Identifier: NCT02810535
Recruitment Status : Completed
First Posted : June 23, 2016
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Stefan Zielen, Johann Wolfgang Goethe University Hospital

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.

Condition or disease Intervention/treatment Phase
Perennial Rhinitis Other: Observation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Local IgE in Subjects With Allergic or Non-allergic Rhinitis
Study Start Date : May 2016
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : September 19, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Common Cold

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

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




Primary Outcome Measures :
  1. 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 Measures :
  1. Comparison of specific IgE between 24 subjects with non-allergic rhinitis, 24 subjects with allergic rhinitis and 20 healthy subjects. [ Time Frame: one year ]
  2. Correlation between Peak Nasal Inspiratory Flow as well as the nasal symptoms in nasal provocation test and local specific IgE. [ Time Frame: one year ]
  3. 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 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810535


Locations
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Germany
Goethe University Hospital Frankfurt
Frankfurt am Main, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
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Principal Investigator: Stefan Zielen, Professor Department for children and adolescents, division of allergy, pneumology, and cystic fibrosis

Publications of Results:
Other Publications:
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Responsible Party: Stefan Zielen, Professor of pediatrics, allergy, pneumology, cystic fibrosis, Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT02810535     History of Changes
Other Study ID Numbers: FRA.LISA.2015
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Stefan Zielen, Johann Wolfgang Goethe University Hospital:
Local IgE
Non-allergic rhinitis
Allergic rhinitis to house dust mite

Additional relevant MeSH terms:
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Rhinitis
Common Cold
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases