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Prevalence of Nasal Hyperreactivity in Chronic Upper Airway Inflammation

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03893227
Enrollment
756
Registered
2019-03-28
Start date
2019-01-22
Completion date
2020-12-31
Last updated
2021-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERQuestionnaire

Patients and healthy controls will fill out a questionnaire

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of the proportion of patients and healthy volunteers with nasal hyperreactivity3 monthsEvery 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

MeasureTime frameDescription
Comparison of nasal symptom severity in patients and healthy volunteers with and without nasal hyperreactivity.3 monthsEvery 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.
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 monthsEvery 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 monthsEvery 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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026