Response of the Airway in Sinusitis and Asthma
Condition: Sinusitis; Asthma
MeSH terms: Sinusitis; Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      Persistence of CRS and asthma require multiple interconnected feedback and feed-forward
      circuits between ILCs and epithelial cells. It seems that type 2 ILCs (ILC2) are the most
      important accelerators of type II immune response that prepare cytokine microenvironment for
      Th2 cells chronic activation. What decide on ILC2 accumulation - this is an urgent question.
      The aim of the proposed project is to examine the role of the innate immune response of
      airways in children suffering from chronic rhinosinusitis and asthma.

      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 CRS (fulfilling the EPOS criteria) and asthma (fulfilling the 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: SN-5 and cACT questionnaires, skin prick test, spirometry, measurement of NO in exhaled
      breath, taste perception test, eosinophil morphology assessment, ratio: glucose concentration
      in nasal secretion/serum glucose level, concentration of specific immunoglobulin E, total IgG
      and IgA, the proportion of ILC2 cells and regulatory 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) PCR examination for the detection of
      the presence of viral and bacterial genetic material, ii) measurement of the expression of
      the various mRNA types, iii) measurement of the expression of mRNA for the
      Epithelial-Mesenchymal Transition (EMT) genes and iv) percentage of ILC 1, 2 and 3 cells and
      regulatory cells.
    

Intervention name(s): Mometasone Nasal; placebo mometasone
Intervention type(s): Drug; Drug
Intervention description(s): a group of children who will receive a nasal mometasone in an atomiser for three months (one application, once per day) and supplemental 3ml 0.9% Sodium chloride (NaCl) solution in a nasal nebuliser once a day for 3 months; a group of children without IgE-dependent hypersensitivity who will receive nasal mometasone placebo in an atomiser for three months (one application, once per day) and supplemental 3ml 0.9% NaCl solution in a nasal nebuliser once a day for 3 months,
Other intervention name(s): NasometinTM, Sandoz; placebo
Intervention MeSH terms: Mometasone Furoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment