Short summary

In this multicenter observational study we investigate the possibility of an undiagnosed underlying immune defect in 500 adult patients with chronic rhinosinusitis.

Rationale

Chronic rhinosinuitis (CRS) is a well-described disorder of the nose and paranasal sinus. CRS is defined by the international EPOS guidelines in accordance to certain symptoms and objective findings, all of which must be present for at least 12 weeks.

In Denmark the prevalence of CRS is 9%, which translates to around 500.000 affected Danish citizens.

Standard treatment for CRS includes daily nasal saline irrigation, daily intranasal topical steroids and individually (repeating) antibiotics and/or systemic steroids administration. Sinus surgery can be considered if listed conservative treatment fails to provide symptom control.

5-25% of patients with CRS do not obtain disease control with standard treatment and are referred to as recalcitrant.

In Denmark we have no systematic approach or treatment protocol for this patient group, which leads to risk of repeated revision surgery with increasing surgical risk, morbidity and unsatisfactory results.

This patient group poses a socio-economic burden because of a need for repeating consultations, ongoing medical treatment, possible (repeating) surgery and recurrent need for sick leave. Moreover, it is shown in several studies that CRS has a significant impact on quality of life.

International studies have shown that as much as 2/3 of patients with recalcitrant CRS have an underlying primary immune defect (PID), which comprise a number of defects in the immune system, which could be the reason for suboptimal disease control.

The prevalence of PID in this patient group is therefore around 100 times higher than in the background population.

It has also been shown that patients with CRS and PID benefit from specific treatment for the diagnosed PID. 

Denmark has no tradition for offering systematic work up for PID in patients with recalcitrant CRS.

Existing studies on the correlation between CRS and PID are not directly comparable considering patient cohorts and differences in work up panel. 

The prevalence of recalcitrant CRS and the prevalence of PID in a Danish CRS population have not previously been investigated.

The purpose of the study is to investigate the prevalence of PID in patients with CRS.

We expect that PID in CRS patients in Denmark proves underdiagnosed.

The hypothesis is that up to 25% of Danish patients with CRS will be recalcitrant and one third of these will have a PID.

Description of the cohort

500 adult patients will be included in the study. The inclusion criteria is chronic rhinosinuisitis (with or without nasal polyps) according to EPOS definition. Exclusion of patients with known immune deficiency or ongoing treatment with systemic steroids.

Data and biological material

Patients fill out a form considering medicine, tobacco and alcohol use. Number of antibiotic courses prescribed the latest year is noted. A validated questionnare about sinonasal symptoms (SNOT-22) is filled out. Blood sample is collected and the result of recent (within 1 year) skin prick test is registered.

Collaborating researchers and departments

Department of ENT, Regional Hospital West Jutland, Holstebro

• Consultant, professor Therese Ovesen

Department of ENT, The Hospital of South West Jutland, Esbjerg

• Administrating consultant, Stig Krarup Petersen

Department of ENT, The Hospital of South Jutland, Søndeborg

• Senior consultant, Susanne Holm Nielsen

Publications associated with the project