Prevalence of Nasal Hyperreactivity in Chronic Upper Airway Inflammation

Prevalence of Nasal Hyperreactivity in Chronic Upper Airway Inflammation: a Prevalence Study

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.

Study Overview

• Status: Completed
• Conditions: Chronic Rhinosinusitis (Diagnosis); Chronic Rhinitis; Hyperactivity; Upper Respiratory Disease
• Intervention / Treatment: Other: Questionnaire

• Study Type: Observational
• Enrollment (Actual): 756

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZLeuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with chronic inflammation of the upper airways. Controls without chronic inflammation of the upper airways.

Description

PATIENTS

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Patients with chronic upper airway inflammation	Other: Questionnaire; Patients and healthy controls will fill out a questionnaire
Healthy control; Healthy controls without chronic upper airway inflammation	Other: Questionnaire; Patients and healthy controls will fill out a questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the proportion of patients and healthy volunteers with nasal hyperreactivity	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of nasal symptom severity in patients and healthy volunteers with and without nasal hyperreactivity.	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.	3 months
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.	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.	3 months
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.	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.	3 months

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Laura Van Gerven, PhD, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2019
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (Actual): March 28, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2021
• Last Update Submitted That Met QC Criteria: March 11, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Otorhinolaryngologic Diseases; Nose Diseases; Inflammation; Rhinitis; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: S62213

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No