Mediators in Nasal Hyperreactivity in Allergic Rhinitis and Chronic Rhinosinusitis

NCT04286542 | Unknown

• 1 other identifier: S63139
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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).

Conditions

Hyperactivity; Allergic Rhinitis Due to House Dust Mite; Chronic Rhinosinusitis With Nasal Polyps

Outcome Measures

Primary Outcomes (1)

• Objective nasal hyperreactivity

  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 Outcomes (12)

• 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

Study Arms (1)

Provocation with cold air

EXPERIMENTAL

Participants will be exposed to cold dry air for 15 minutes

Diagnostic Test: Cold, dry air

Interventions

Cold, dry air DIAGNOSTIC_TEST

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

Provocation with cold air

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

KULeuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Spasm

Interventions

Cold Temperature

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Temperature; Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor doctor

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

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: February 27, 2020
• Study Start: January 20, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)