Prevalence of Nasal Hyperreactivity in Chronic Upper Airway Inflammation

Completed

• Conditions: Chronic Rhinitis; Upper Respiratory Disease; Hyperactivity; Chronic Rhinosinusitis (Diagnosis)
• Interventions: Other: Questionnaire

• Registration Number: NCT03893227
• Lead Sponsor: Universitaire Ziekenhuizen KU 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 determine the prevalence and severity of nasal hyperreactivity in patients with chronic upper airway inflammation. To this end, patients and healthy controls will be asked to fill out a questionnaire inquiring presence and severity of nasal symptoms upon exposure to particular environmental triggers.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-22
• Study First Submitted: 2019-03-20
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-28
• Primary Completion: 2020-09-30
• Study Completion: 2020-12-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-11
• Last Update Posted: 2021-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 756

Inclusion Criteria

• age 18-65 y
• Nasal inflammatory symptoms for 12 weeks or longer (nasal obstruction, post-nasal drip, rhinorrhea, loss of smell, sneezing/itch, facial pain)
• Signed informed consent

Exclusion Criteria

• Current or medical history of malignancy in the last ten years

CONTROLS

Inclusion Criteria:

• age 18-65 y
• No nasal inflammatory symptoms for 12 weeks or longer (nasal obstruction, post-nasal drip, rhinorrhea, loss of smell, sneezing/itch, facial pain)
• Signed informed consent

Exclusion Criteria:

• Current or medical history of malignancy in the last ten years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Questionnaire	Patients with chronic upper airway inflammation
Healthy control	Questionnaire	Healthy controls without chronic upper airway inflammation

Primary Outcome Measures

Name	Time	Method
Comparison of the proportion of patients and healthy volunteers with nasal hyperreactivity	3 months	Every participant will fill out a questionnaire inquiring presence of nasal symptoms evoked by environmental triggers and lasting longer than ten minutes (nasal hyperreactivity). The proportion of patients and healthy volunteers with nasal hyperreactivity will be compared.

Secondary Outcome Measures

Name	Time	Method
Comparison of the proportion of healthy volunteers and four groups of patients (allergic rhinitis, non-allergic non-infectious rhinitis, chronic rhinosinusitis with nasal polyps, chronic rhinosinusitis without nasal polyps) with nasal hyperreactivity.	3 months	Every participant will fill out a questionnaire inquiring presence of nasal symptoms evoked by environmental triggers and lasting longer than ten minutes (nasal hyperreactivity). The proportion of healthy volunteers and four groups of patients (allergic rhinitis, non-allergic non-infectious rhinitis, chronic rhinosinusitis with nasal polyps, chronic rhinosinusitis without nasal polyps) with nasal hyperreactivity will be compared.
Comparison of nasal symptom severity in healthy volunteers and four groups of patients [allergic rhinitis, non-allergic non-infectious rhinitis, chronic rhinosinusitis (CRS) with and CRS without nasal polyps] with and without nasal hyperreactivity.	3 months	Every participant will fill out a questionnaire inquiring nasal symptom severity by means of a visual analogue scale (VAS). The severity of symptoms will be scored on a horizontal line of 10 cm, where 0 cm equals "no symptoms" and 10 cm equals "very severe symptoms". The VAS-scores of healthy volunteers and four groups of patients (allergic rhinitis, non-allergic non-infectious rhinitis, chronic rhinosinusitis with nasal polyps, chronic rhinosinusitis without nasal polyps) with and without nasal hyperreactivity will be compared.
Comparison of nasal symptom severity in patients and healthy volunteers with and without nasal hyperreactivity.	3 months	Every participant will fill out a questionnaire inquiring nasal symptom severity by means of a visual analogue scale (VAS). The severity of symptoms will be scored on a horizontal line of 10 cm, where 0 cm equals "no symptoms" and 10 cm equals "very severe symptoms". The VAS-scores of patients and healthy volunteers with and without nasal hyperreactivity will be compared.

Trial Locations

Locations (1)

UZLeuven; 🇧🇪 Leuven, Belgium