- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04286542
Mediators in Nasal Hyperreactivity in Allergic Rhinitis and Chronic Rhinosinusitis
Identification of Mediators Associated With Presence of Nasal Hyperreactivity in Allergic Rhinitis and Chronic Rhinosinusitis
Rhinitis, or inflammation of the nasal mucosa, can present with nasal obstruction, nasal discharge, itch or sneezing. If the sinusal mucosa is involved as well, it is called rhinosinusitis and facial pain or loss of smell is possible. Several causes are known, such as an underlying allergy ("allergic rhinitis", AR). If at least 2 symptoms are present for at least 12 weeks, it is called "chronic rhinosinusitis" (CRS).
Up to 2/3 of the AR and CRS patients have symptoms upon exposure to triggers such as sudden temperature changes, smoke, fragrances… a phenomenon called "nasal hyperreactivity" (NHR). It is currently not clear why some patients suffer NHR while others do not.
In this study, the investigators want to identify the mediators associated with NHR in patients with allergic rhinitis, chronic rhinosinusitis and healthy control subjects.To do so, participants will be provoked with cold, dry air in order to objectively diagnose NHR. Before and after provocation, the peak nasal inspiratory flow will be measured and samples will be collected (nasal secretions, biopsies).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients with perennial allergic rhinitis, chronic rhinosinusitis with nasal polyps and healthy control subjects will be recruited. At baseline, nasal secretions and mucosal biopsies will be collected. After 3 weeks, participants will be provoked with cold, dry air, and samples will be harvested again. A decrease in the peak nasal inspiratory flow of >20% will be used as a cutoff to define nasal hyperreactivity.
Nasal secretions will be analysed for various mediators using a multiplex assay. The biopsies will be used for RT-q-PCR and immunohistochemistry of various transient receptor potential (TRP) channels.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Leuven, Belgium, 3000
- KULeuven
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18-65 years
- positive skin prick test for house dust mite (for allergic rhinitis group), presence of nasal polyps (for chronic rhinosinusitis with nasal polyps group)
- VAS-score >5 for rhino(sinus)itis symptoms
Exclusion Criteria:
- positive skin prick test (for chronic rhinosinusitis with nasal polyps group and healthy control group), presence of nasal polyps (for allergic rhinitis group and healthy control group)
- Acute rhinitis in the past 2 weeks
- (History of) immunotherapy for house dust mite
- Relevant anatomic abnormalities
- Participation in another clinical trial at the moment of this study.
- Use of anticoagulants (apart from acetylsalicylic acid)
- Use of tricyclic antidepressants
- History of intranasal drug usage in the past 12 months
- Pregnancy or breastfeeding
- Malignancy or severe comorbidity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Provocation with cold air
Participants will be exposed to cold dry air for 15 minutes
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Participants will be exposed to cold (<-10°C, <10% relative humidity), dry air for 15 minutes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective nasal hyperreactivity
Time Frame: 3 weeks
|
The peak nasal inspiratory flow will be measured before and after provocation with cold, dry air.
A decrease of >20% will be used as a cutoff to objectively diagnose nasal hyperreactivity.
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Levels of histamine in nasal secretions
Time Frame: 3 weeks
|
In nasal secretions, the investigators will measure the levels of histamine by using a multiplex assay.
They will do so at baseline and after cold dry air provocation test.
|
3 weeks
|
Levels of tryptase in nasal secretions
Time Frame: 3 weeks
|
In nasal secretions, the investigators will measure the levels of tryptase by using a multiplex assay.
They will do so at baseline and after cold dry air provocation test.
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3 weeks
|
Levels of substance P in nasal secretions
Time Frame: 3 weeks
|
In nasal secretions, the investigators will measure the levels of substance P by using a multiplex assay.
They will do so at baseline and after cold dry air provocation test.
|
3 weeks
|
Levels of neurokinin A in nasal secretions
Time Frame: 3 weeks
|
In nasal secretions, the investigators will measure the levels of neurokinin A by using a multiplex assay.
They will do so at baseline and after cold dry air provocation test.
|
3 weeks
|
Levels of neurokinin B in nasal secretions
Time Frame: 3 weeks
|
In nasal secretions, the investigators will measure the levels of neurokinin B by using a multiplex assay.
They will do so at baseline and after cold dry air provocation test.
|
3 weeks
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Levels of calcitonin gene-related peptide in nasal secretions
Time Frame: 3 weeks
|
In nasal secretions, the investigators will measure the levels of calcitonin gene-related peptide by using a multiplex assay.
They will do so at baseline and after cold dry air provocation test.
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3 weeks
|
Levels of interleukin (IL) 4 in nasal secretions
Time Frame: 3 weeks
|
In nasal secretions, the investigators will measure the levels of IL-4 by using a multiplex assay.
They will do so at baseline and after cold dry air provocation test.
|
3 weeks
|
Levels of IL-5 in nasal secretions
Time Frame: 3 weeks
|
In nasal secretions, the investigators will measure the levels of IL-5 by using a multiplex assay.
They will do so at baseline and after cold dry air provocation test.
|
3 weeks
|
Levels of IL-13 in nasal secretions
Time Frame: 3 weeks
|
In nasal secretions, the investigators will measure the levels of IL-13 by using a multiplex assay.
They will do so at baseline and after cold dry air provocation test.
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3 weeks
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Presence of TRP Vanilloid 1 in nasal mucosa.
Time Frame: 3 weeks
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The investigators will determine the presence of TRP vanilloid 1 on nasal mucosal biopsies at baseline and after provocation with cold, dry air by using RT-q-PCR and immunohistochemistry.
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3 weeks
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Presence of TRP Ankyrin 1 in nasal mucosa.
Time Frame: 3 weeks
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The investigators will determine the presence of TRP Ankyrin 1 on nasal mucosal biopsies at baseline and after provocation with cold, dry air by using RT-q-PCR and immunohistochemistry.
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3 weeks
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Presence of TRP Melastatin 8 in nasal mucosa.
Time Frame: 3 weeks
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The investigators will determine the presence of TRP Melastatin 8 on nasal mucosal biopsies at baseline and after provocation with cold, dry air by using RT-q-PCR and immunohistochemistry.
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3 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Pathological Conditions, Anatomical
- Respiratory Hypersensitivity
- Hypersensitivity
- Paranasal Sinus Diseases
- Nose Diseases
- Polyps
- Sinusitis
- Rhinitis
- Rhinitis, Allergic
- Nasal Polyps
Other Study ID Numbers
- S63139
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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