Mometasone Furoate Nasal Spray in Italian Children

Study Overview
=================
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.

Official Title
-----------------
Mometasone Furoate Nasal Spray in Italian Children With Seasonal Allergic Rhinitis: a Comprehensive Assessment

Conditions
-----------------
Rhinitis, Allergic, Nasal Allergy, Allergy Pollen, Nasal, Cytology, Mometasone Allergy, Quality of Life, Child, Only

Intervention / Treatment
-----------------
* Diagnostic Test: Nasal cytology
* Other: The validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)
* Other: Total symptom score (TSS)
* Other: Visual analogic scale (VAS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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: 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.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Group<br> | Diagnostic Test: Nasal cytology<br>* 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).<br>Other: The validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)<br>* 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.<br>Other: Total symptom score (TSS)<br>* 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<br>Other: Visual analogic scale (VAS)<br>* A visual analogic scale (VAS) measured the parental perception of symptom severity (0=no symptom; 10=very severe symptoms).<br>|
| Control Group<br> | Diagnostic Test: Nasal cytology<br>* 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).<br>Other: The validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)<br>* 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.<br>Other: Total symptom score (TSS)<br>* 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<br>Other: Visual analogic scale (VAS)<br>* A visual analogic scale (VAS) measured the parental perception of symptom severity (0=no symptom; 10=very severe symptoms).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in eosinophils, mast cells and neutrophil infiltrate by nasal cytology after the treatment | The primary endpoint of this study was the change in eosinophilic mast cells and neutrophil infiltrate, assessed by nasal cytology | 2019-2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assesment of symptoms during the study | The secondary objective was the nasal symptom severity during the study assessed by total symptom score (TSS) | 2019-2021 | 
| Assesment of quality of life changes during the study | The secondary objective was the changes of quality of life during the study assessed by the validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) | 2019-2021 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
seasonal allergic rhinitis, mometasone furoate nasal spray, nasal cytology, type 2 inflammation, symptoms, quality of life