Perennial RhinitisLISANCT02810535
Local IgE in Subjects With Allergic or Non-allergic Rhinitis
A study testing Observation in people with Perennial Rhinitis, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Perennial Rhinitis
- What is being tested?
- Observation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- May 2016to 19 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent
- Seasonal or all-season symptoms of an allergic or non-allergic rhinitis
- Healthy non-allergic subjects
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Goethe University Hospital Frankfurt
Frankfurt am Main, Hesse, 60590
About this study
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.
Read the 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.
- Conditions
- Perennial Rhinitis
- Being tested
- Observation
- Keywords
- Local IgE, Non-allergic rhinitis, Allergic rhinitis to house dust mite
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Allergic rhinitis | Active comparator | Clinical observation of 24 subjects with nasal symptoms and positive prick test for house dust mite Receives: Other: Observation |
| Non-allergic rhinitis | Experimental | Clinical observation of 24 subjects with nasal symptoms and negative prick test for house dust mite Receives: Other: Observation |
| Healthy Control | Other | Clinical observation of 20 subjects without nasal symptoms and with negative prick test Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of IgE between 24 subjects with non-allergic rhinitis, 24 subjects with allergic rhinitis and 20 healthy subjects.
Measured: 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.
Measured: one year
Correlation between Peak Nasal Inspiratory Flow as well as the nasal symptoms in nasal provocation test and local specific IgE.
Measured: 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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startMay 2016
- Primary completion1 Aug 2017
- Study completion19 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Perennial RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Zielen, Johann Wolfgang Goethe University Hospital
- Investigators
- Stefan Zielen, Professor, Principal investigator, Department for children and adolescents, division of allergy, pneumology, and cystic fibrosis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810535
- Sponsor's protocol ID
- FRA.LISA.2015
- Acronym
- LISA
- Status last verified
- Nov 2017
- First submitted
- 31 May 2016
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 15248853Litvyakova 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.
PubMed 11345277Buslau 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.
PubMed 25270425Campo 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.
PubMed 25495772Huggins 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.
PubMed 49744Eckrich 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.
PubMed 32612737
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local IgE in Subjects With Allergic or Non-allergic Rhinitis
- ClinicalTrials.gov ID
- NCT02810535
- Acronym / sponsor ID
- LISA / FRA.LISA.2015
- Conditions
- Perennial Rhinitis
- Keywords
- Local IgE, Non-allergic rhinitis, Allergic rhinitis to house dust mite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 19 Sep 2017 (actual)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Allergic rhinitis | Active comparator | Other: ObservationClinical observation of 24 subjects with nasal symptoms and positive prick test for house dust mite |
| Non-allergic rhinitis | Experimental | Other: ObservationClinical observation of 24 subjects with nasal symptoms and negative prick test for house dust mite |
| Healthy Control | Other | Other: ObservationClinical observation of 20 subjects without nasal symptoms and with negative prick test |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Informed consent
- Seasonal or all-season symptoms of an allergic or non-allergic rhinitis
- Healthy non-allergic subjects
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationVisit 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 | Other | Allergic rhinitis, Healthy Control, Non-allergic rhinitis |
Primary outcome
Comparison of IgE between 24 subjects with non-allergic rhinitis, 24 subjects with allergic rhinitis and 20 healthy subjects.
Time frame: one year
3 secondary outcomes
Comparison of specific IgE between 24 subjects with non-allergic rhinitis, 24 subjects with allergic rhinitis and 20 healthy subjects.
Time frame: one year
Correlation between Peak Nasal Inspiratory Flow as well as the nasal symptoms in nasal provocation test and local specific IgE.
Time frame: 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.
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Background: PubMed 15248853Bez 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.
- Background: PubMed 11345277Litvyakova 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 publication: PubMed 25270425Buslau 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 publication: PubMed 25495772Campo 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 publication: PubMed 49744Huggins 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.
- Derived from this study: PubMed 32612737Eckrich 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Zielen, Professor principal investigator
Department for children and adolescents, division of allergy, pneumology, and cystic fibrosis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Observation in people with Perennial Rhinitis, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of IgE between 24 subjects with non-allergic rhinitis, 24 subjects with allergic rhinitis and 20 healthy subjects. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02810535, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2017.