Prevalence of Nasal Hyperreactivity in Chronic Upper Airway Inflammation

Chronic Rhinosinusitis (Diagnosis) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03893227
• Other study ID #: S62213
• Status: Completed
• Start date: January 22, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2021
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 756
• Est. completion date: December 31, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Rhinitis
• Chronic Rhinosinusitis (Diagnosis)
• Hyperactivity
• Inflammation
• Respiration Disorders
• Respiratory Tract Diseases
• Rhinitis
• Upper Respiratory Disease

Intervention

Other:
• Questionnaire
Patients and healthy controls will fill out a questionnaire

Locations

Country	Name	City	State
Belgium	UZLeuven	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	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	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
Secondary	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
Secondary	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