At a glance
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Mometasone Furoate Nasal Spray in Italian Children With Seasonal Allergic Rhinitis: a Comprehensive Assessment
In Brief
An observational study evaluating Nasal cytology, The validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ), and 2 other interventions for Rhinitis, Allergic and 6 related conditions. Completed, enrolled 80 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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).