Mometasone Furoate Nasal Spray in Italian Children
- Conditions
- Rhinitis, AllergicNasal, CytologyMometasone AllergyQuality of LifeNasal AllergyAllergy PollenChild, Only
- Interventions
- Diagnostic Test: Nasal cytologyOther: The validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)Other: Total symptom score (TSS)Other: Visual analogic scale (VAS)
- Registration Number
- NCT05301647
- Lead Sponsor
- University of Campania "Luigi Vanvitelli"
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- Inclusion criteria were: age range 4-12 years, SAR diagnosis, Total Symptoms Score (TSS) ≥ 6, and written informed consent of both parents or legal guardians.
- Exclusion criteria were: perennial AR, rhinitis due to other causes, concomitant acute or chronic rhinosinusitis, nasal polyps, asthma comorbidity, current use of topical or systemic corticosteroids, antihistamines, antileukotrienes, inadequate washout of them, nasal anatomic defect, respiratory infections in the last two weeks, participation in other clinical studies in the previous month, documented hypersensitivity to the study product or its excipients, and trip planned outside of the study area.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control Group Nasal cytology - Active Group Nasal cytology - Control Group The validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) - Control Group Total symptom score (TSS) - Control Group Visual analogic scale (VAS) - Active Group Total symptom score (TSS) - Active Group Visual analogic scale (VAS) - Active Group The validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) -
- Primary Outcome Measures
Name Time Method Change in eosinophils, mast cells and neutrophil infiltrate by nasal cytology after the treatment 2019-2021 The primary endpoint of this study was the change in eosinophilic mast cells and neutrophil infiltrate, assessed by nasal cytology
- Secondary Outcome Measures
Name Time Method Assesment of symptoms during the study 2019-2021 The secondary objective was the nasal symptom severity during the study assessed by total symptom score (TSS)
Assesment of quality of life changes during the study 2019-2021 The secondary objective was the changes of quality of life during the study assessed by the validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)
Trial Locations
- Locations (1)
Second University
🇮🇹Naples, Italy