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

Sponsors

Lead Sponsor: Universitaire Ziekenhuizen Leuven

Source Universitaire Ziekenhuizen Leuven
Brief Summary

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).

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.

Overall Status Recruiting
Start Date January 20, 2020
Completion Date September 2022
Primary Completion Date December 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Objective nasal hyperreactivity 3 weeks
Secondary Outcome
Measure Time Frame
Levels of histamine in nasal secretions 3 weeks
Levels of tryptase in nasal secretions 3 weeks
Levels of substance P in nasal secretions 3 weeks
Levels of neurokinin A in nasal secretions 3 weeks
Levels of neurokinin B in nasal secretions 3 weeks
Levels of calcitonin gene-related peptide in nasal secretions 3 weeks
Levels of interleukin (IL) 4 in nasal secretions 3 weeks
Levels of IL-5 in nasal secretions 3 weeks
Levels of IL-13 in nasal secretions 3 weeks
Presence of TRP Vanilloid 1 in nasal mucosa. 3 weeks
Presence of TRP Ankyrin 1 in nasal mucosa. 3 weeks
Presence of TRP Melastatin 8 in nasal mucosa. 3 weeks
Enrollment 144
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: Cold, dry air

Description: Participants will be exposed to cold (<-10°C, <10% relative humidity), dry air for 15 minutes.

Arm Group Label: Provocation with cold air

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Contact

Last Name: Wout Backaert

Phone: +3216332346

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: KULeuven Wout Backaert +3216332346 [email protected]
Location Countries

Belgium

Verification Date

June 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Universitaire Ziekenhuizen Leuven

Investigator Full Name: Laura Van Gerven

Investigator Title: Professor doctor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Provocation with cold air

Type: Experimental

Description: Participants will be exposed to cold dry air for 15 minutes

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: Visit 1: screening, baseline sample collection. Visit 2: sample collection, provocation with cold dry air, sample collection

Primary Purpose: Basic Science

Masking: None (Open Label)

Source: ClinicalTrials.gov