The project is intended to be realised in two phases. In the first stage, a case control
study will be performed. In the second phase, double-blind, placebo controlled study will be
conducted. In the first phase 3 groups of children will be compare: i) a group of children
suffering from chronic rhinosinusitis (CRS) (fulfilling the European Position Paper on
Rhinosinusitis and Nasal Polyps (EPOS) criteria) and asthma (fulfilling the Asthma Predictive
Index (API) criteria) (CRS+/asthma+, n=90), ii) a group of children suffering from CRS
(fulfilling the EPOS criteria) but without asthma symptoms (negative API criteria)
(CRS+/asthma-, n=30) and iii) a group of children without symptoms of CRS (negative EPOS
criteria) and without asthma symptoms (negative API criteria) (CRS-/asthma-, n=30). In the
second phase the effect of intranasal glucocorticosteroids will be assessed. The following
research methods will be used: CRS-symptom score questionnaire (SN-5) and Childhood Asthma
Control Test (cACT) questionnaires, skin prick test, spirometry, measurement of nitric oxide
NO in exhaled breath (FeNO), taste perception test, eosinophil morphology assessment, ratio:
glucose concentration in nasal secretion/serum glucose level, concentration of specific
immunoglobulin (Ig) E, total immunoglobulin G (IgG) and immunoglobulin A (IgA), the
proportion of innate lymphoid cells (ILC) and regulatory lymphocytes cells in the peripheral
blood. Endoscopic examination of the upper airways will be performed and samples of the
mucosa will be taken. The mucosal examination will be as follows: i) polymerase chain
reaction (PCR) examination for the detection of the presence of viral and bacterial genetic
material, ii) measurement of the expression of the various messenger ribonucleic acid (mRNA),
iii) measurement of the expression of mRNA for the Epithelial-Mesenchymal Transition (EMT)
genes and iv) percentage of ILCs.
Phase:
Phase 4
Details
Lead Sponsor:
Medical University of Lodz Medical Universtity of Lodz