Prevalence of Nasal Hyperreactivity in Chronic Upper Airway Inflammation

NCT03893227 | Completed

• 1 other identifier: S62213
• Study Type: observational
• Target: 756
• 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 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.

Conditions

Hyperactivity; Chronic Rhinosinusitis (Diagnosis); Chronic Rhinitis; Upper Respiratory Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Comparison of nasal symptom severity in patients and healthy volunteers with and without nasal hyperreactivity.

  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.

  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.

  3 months

Study Arms (2)

Patients

Patients with chronic upper airway inflammation

Other: Questionnaire

Healthy control

Healthy controls without chronic upper airway inflammation

Other: Questionnaire

Interventions

Questionnaire OTHER

Patients and healthy controls will fill out a questionnaire

Healthy control; Patients

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZLeuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Spasm; Disease; Respiration Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Laura Van Gerven, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor doctor

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: March 28, 2019
• Study Start: January 22, 2019
• Primary Completion: September 30, 2020
• Study Completion: December 31, 2020
• Last Updated: March 12, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)