Mediators in Nasal Hyperreactivity in Allergic Rhinitis and Chronic Rhinosinusitis

Chronic Rhinosinusitis With Nasal Polyps Clinical Trial

Official title:

Identification of Mediators Associated With Presence of Nasal Hyperreactivity in Allergic Rhinitis and Chronic Rhinosinusitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04286542
• Other study ID #: S63139
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: December 2022

Study information

• Verified date: May 2022
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 144
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis Due to House Dust Mite
• Chronic Rhinosinusitis With Nasal Polyps
• Hyperactivity
• Nasal Polyps
• Rhinitis
• Rhinitis, Allergic
• Sinusitis

Intervention

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

Locations

Country	Name	City	State
Belgium	KULeuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Levels of histamine in nasal secretions	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
Secondary	Levels of tryptase in nasal secretions	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.	3 weeks
Secondary	Levels of substance P in nasal secretions	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
Secondary	Levels of neurokinin A in nasal secretions	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
Secondary	Levels of neurokinin B in nasal secretions	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
Secondary	Levels of calcitonin gene-related peptide in nasal secretions	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.	3 weeks
Secondary	Levels of interleukin (IL) 4 in nasal secretions	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
Secondary	Levels of IL-5 in nasal secretions	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
Secondary	Levels of IL-13 in nasal secretions	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.	3 weeks
Secondary	Presence of TRP Vanilloid 1 in nasal mucosa.	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.	3 weeks
Secondary	Presence of TRP Ankyrin 1 in nasal mucosa.	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.	3 weeks
Secondary	Presence of TRP Melastatin 8 in nasal mucosa.	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.	3 weeks