Serum MicroRNAs 223 and 146a in Allergic Rhinitis Patients as Biomarkers for Efficacy of Sublingual Immunotherapy
Condition: Effects of Immunotherapy
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is:

        -  to evaluate the serum levels of miR-223 and miRNA146a and to assess their correlation
           with disease severity in allergic rhinitis patients and their role as biomarkers for
           efficacy of sublingual immunotherapy.

        -  also to find if high sensitivity CRP can be an easy non-expensive test for diagnosis and
           follow up of allergic rhinitis patients.
    

Detailed description: 
      Over the last decades the prevalence of allergic disease has steadily been rising and recent
      figures indicate that in the western world 10-25% of people are affected with allergic
      diseases ranging from food allergy, atopic dermatitis/ eczema, allergic rhinitis, hay fever
      to asthma.

      Allergic rhinitis (AR) is the most frequent allergic disease in Western Europe that
      interferes with school attendance and performance, with a prevalence rate of 20-30%. Very few
      studies of the epidemiology were done about the prevalence of allergic rhinitis in Egypt as
      its prevalence was 9 %.

      Allergic rhinitis is allergen-specific IgE-mediated inflammatory reactions which is
      characterized by excessive eosinophil infiltration, Th2 cytokine responses such as IL5, IL4,
      IL13, and mucus secretion. The prevalence of allergic rhinitis is increasing worldwide due to
      changes in the socioeconomic status, environmental factor, and occupational factor. AR burden
      on sleep and learning is substantial in children. Moreover, AR is considered a risk factor
      for subsequent asthma comorbidity.

      Allergic rhinitis is characterized by nasal congestion, itching, rhinorrhea, and sneezing,
      which are manifested as a consequence of inappropriate immune responses mediated by allergen
      specific immunoglobulin E (IgE) antibodies toward otherwise harmless antigens such as pollen
      and house dust mite (HDM).

      High-sensitivity-C-reactive protein (hs-CRP) is a well-known systemic inflammatory marker
      that is easy and inexpensive to measure, together with ESR, serum Ig-E and total eosinophil
      count are measured as laboratory markers of allergic diseases.

      MicroRNAs (miRNAs) are small non-coding RNA molecules that are 18-22 nucleotides long and
      highly conserved throughout evolution. MiRNAs play important roles in numerous disease
      processes such as asthma and allergic rhinitis and that differential miRNA expression can
      identify novel subtypes of these diseases. As approximately 150 miRNAs are detectable in the
      blood, differential miRNA expression patterns may serve as a molecular fingerprint that aids
      in disease diagnosis, characterization, and prognosis.

      MiRNAs may have particular clinical utility in allergic diseases. These diseases are
      characterized by tissue inflammation and are particularly difficult to diagnose and
      characterize considering that measuring releasing mediators, such as cytokines in blood which
      their characteristic measurement is unreliable . As a result, invasive methods (e.g.,
      bronchoscopy and tissue biopsies) are needed to quantify inflammatory changes. It follows
      that miRNA expression profiling in blood and other body fluids becomes important for
      identifying and developing novel, non-invasive disease Biomarkers.

      One of the most significantly upregulated molecules was miR-223 involved in eosinophilic
      inflammation and associated with lower regulatory T-cell numbers. It is well known that Treg
      cells play an important role in development of tolerance by producing IL-10. Thus, in the
      future inhibition of miR-223 could be considered an adjuvant treatment.

      MiR-146a is one of the two members of the miR-146 miR family. It has been reported to be
      involved in a large number of cell activi¬ties, such as suppression of cancer growth,
      inhibition of inflam¬mation, regulation of the immune system and suppression of allergic
      inflammation. MiR-146a play a role in regulation of allergic diseases such as allergic
      rhinitis by modulating Treg cells.

      Allergen-specific immunotherapy (AIT) is currently the only known causal effective treatment
      of IgE-mediated allergy. Sublingual immunotherapy is a well-established allergen-specific
      immunotherapy and a safe and effective strategy to reorient inappropriate immune responses in
      allergic patients.

      MiR-146a may play a role in allergen immunotherapy of allergic diseases by modulating Treg
      cells. Also., high miR-223 expression is associated with lower regulatory T-cell numbers.
    

Intervention name(s): Sublingual immunotherapy
Intervention type(s): Other
Intervention description(s): Sublingual immunotherapy give to allergic rhinitis patients for treatment
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Allergen immunotherapy; MiRNA-223; MiRNA-146a