Ignite Creation Date:
2024-05-06 @ 2:19 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04286542
Status:
UNKNOWN
Last Update Posted:
2022-05-25
First Post:
2020-02-21
Brief Title:
Mediators in Nasal Hyperreactivity in Allergic Rhinitis and Chronic Rhinosinusitis
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Identification of Mediators Associated With Presence of Nasal Hyperreactivity in Allergic Rhinitis and Chronic Rhinosinusitis
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 23 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 subjectsTo 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
Up to 23 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 subjectsTo 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None