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
Sponsor: University of Campania Luigi Vanvitelli

Title of the study 
Mometasone Furoate Nasal Spray in Italian Children With 
Seasonal Allergic Rhinitis: a Comprehensive Assessment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date of the document October 20, 2021 

Study Protocol and Statistical Analysis Plan 
The present study recruited children suffering from SAR during the pollen season. They had a 
poor control of SAR despite antihistaminic treatment (cetirizine 2.5 mg bid in preschoolers or 
5 mg bid in schoolers). SAR diagnosis was performed according to validated criteria. Allergy 
was defined if nasal symptom history was consistent with documented sensitization. 
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. 
The study was conducted in a third-level pediatrics department located in Southern Italy. The 
study procedure was approved by the local Ethics Committee (Prt n 408, 20/06/2019). 
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. For both groups, 
the schedule was for one spray into each nostril (MFNS 50 mcg/spray) twice a day for 21 days. 
The participants were evaluated at baseline (T0), after 7 (T1) and 21 (T2) days, and 30 days 
(T3) after treatment discontinuation.  
During the study, systemic or intranasal antihistamines, other corticosteroids, leukotriene 
antagonists, and sodium cromoglicate were prohibited.  

The primary endpoint of this study was the change in eosinophilic infiltrate, assessed by nasal 
cytology, after the treatment. The secondary objectives were the nasal mast cell and neutrophil 
count, symptom severity, and QoL changes during the study. 
Nasal cytology is a well-defined methodology. The procedure included sampling, processing, 
and microscope reading. Sampling required collecting cells from the surface of the middle 
portion of the inferior turbinate by a sterile disposable curette. The procedure was performed 
under anterior rhinoscopy, with an appropriate light source, and it was painless. The sample 
obtained was immediately smeared on a glass slide, air-dried, and stained with May-Grünwald-
Giemsa (MGG) for 30 minutes. Next, the stained sample was read at optical microscopy, with 
a 1000x objective with oil immersion. The count of eosinophils, neutrophils, and mast cells 
was expressed as a mean of 10 microscopic fields.  
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). 
Safety was assessed on the incidence of adverse events for each treatment and physical 
examination. 
The statistical analysis included different tests. Shapiro-Wilk test was performed to investigate 
continuous variables distribution. Differences between the active and control group were tested 
with Mann-Whitney U test for independent samples. Longitudinal changes for continuous 
variables were investigated by Wilcoxon signed-rank test for paired samples. Delta changes in 
questionnaires scores were calculated for each group as T1-T0 scores for the control group, 
T2-T0 scores, and T3-T0 scores for the mometasone group. Differences in delta changes 
between groups were investigated by Mann-Whitney U test. Chi-square test and Fisher exact 
test were performed for differences in categorical variables. A p ≤0.05 was considered 
statistically significant. Data were expressed as median (interquartile range) or as a percentage 
as appropriate. All analyses were performed with SAS® on Demand for Academics (Cary, NC: 
SAS Institute Inc.)