Mometasone Furoate Nasal Spray in Italian Children
Condition: Rhinitis, Allergic; Nasal Allergy; Allergy Pollen; Nasal, Cytology; Mometasone Allergy; Quality of Life; Child, Only
MeSH terms: Rhinitis; Rhinitis, Allergic, Seasonal; Rhinitis, Allergic; Hypersensitivity
Study type: Observational

Summary: 
      Objective Seasonal allergic rhinitis (SAR) is a common disease in childhood and characterized
      by type 2 inflammation, bothersome symptoms, and impaired quality of life (QoL). Intranasal
      corticosteroids are effective medications in managing SAR patients. In addition, mometasone
      furoate nasal spray (MFNS) is a well-known therapeutic option. However, the literature
      provided no data about its effects in European children with SAR. Thus this study addressed
      this unmet need.
    

Detailed description: 
      Objective Seasonal allergic rhinitis (SAR) is a common disease in childhood and characterized
      by type 2 inflammation, bothersome symptoms, and impaired quality of life (QoL). Intranasal
      corticosteroids are effective medications in managing SAR patients. In addition, mometasone
      furoate nasal spray (MFNS) is a well-known therapeutic option. However, the literature
      provided no data about its effects in European children with SAR. Thus this study addressed
      this unmet need.

      Methods MFNS was compared to isotonic saline. Both treatments were prescribed one spray per
      nostril, twice a day, per 3 weeks. Nasal cytology, total symptom score (TSS), visual analogic
      scale concerning the parental perception of symptom severity, and the Pediatric
      Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) were assessed at baseline, after 7
      and 21 days, and one month after discontinuation.
    

Intervention name(s): Nasal cytology; The validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ); Total symptom score (TSS); Visual analogic scale (VAS)
Intervention type(s): Diagnostic Test; Other; Other; Other
Intervention description(s): The cytological technique involves the following moments: sampling, processing, which includes fixation, staining and microscopic observation. Cytological sampling consists in the collection of superficial cells of the nasal mucosa with the help of a sterile swab or a small curette (scraping) in disposable plastic material (Rhino-probe).; The validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) consists of 23 questions in 5 domains (nasal symptoms, ocular symptoms, practical issues, limitation of activities, other symptoms) that are answered on a 7-point scale (0-6), where 0 represents the absence of problems and 6 the greatest symptom distress. Children will complete the questionnaire together with a parent at baseline and during the study. A Total Score was calculated as the mean of the 5 domains.; Total symptom score was the sum of 3 domains: i) nasal symptoms (TNSS) included itching, sneezing, rhinorrhea, nasal congestion; ii) ocular symptoms (TOSS): itching, hyperemia of the conjunctiva, tearing; and iii) throat symptoms (TTSS): itching, coughing. With the help of their parents, patients scored symptoms severity on a 4-point scale: 0 = absent or irrelevant, 1 = mild, 2 = moderate, 3 = severe. Total symptom score was assessed at 12 hours (TTS 12h) and two weeks (TTS 2W) before the visits. TSS represents the doctor's point of view of symptom severity; A visual analogic scale (VAS) measured the parental perception of symptom severity (0=no symptom; 10=very severe symptoms).
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Globally, 80 children were enrolled, but 76 (40 males and 36 females, mean age 11.4 + 3.3
        years) completed the study. Children were randomly (ratio 1:1) subdivided into two groups:
        the active group treated with MFNS (Mometasone group) and the control group treated with
        isotonic saline.
      
Keywords: seasonal allergic rhinitis; mometasone furoate nasal spray; nasal cytology; type 2 inflammation; symptoms; quality of life