Clinical trial NCT03893227: Prevalence of Nasal Hyperreactivity in Chronic Upper Airway Inflammation
Official title: Prevalence of Nasal Hyperreactivity in Chronic Upper Airway Inflammation: a Prevalence Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperactivity
Chronic Rhinosinusitis (Diagnosis)
Chronic Rhinitis
Upper Respiratory Disease
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 756
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic inflammation of the upper airways. Controls without chronic inflammation of the upper airways.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the proportion of patients and healthy volunteers with nasal hyperreactivity
timeFrame: 3 months
Secondary outcomes:
measure: Comparison of nasal symptom severity in patients and healthy volunteers with and without nasal hyperreactivity.
timeFrame: 3 months
measure: 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.
timeFrame: 3 months
measure: 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.
timeFrame: 3 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZLeuven
Study officials:
affiliation: UZ Leuven
name: Laura Van Gerven, PhD
role: PRINCIPAL_INVESTIGATOR
References: