Mometasone Furoate Nasal Spray in Italian Children

CompletedOBSERVATIONAL
Enrollment

80

Participants

Timeline

Start Date

June 20, 2019

Primary Completion Date

September 20, 2021

Study Completion Date

October 20, 2021

Conditions
Rhinitis, AllergicNasal AllergyAllergy PollenNasal, CytologyMometasone AllergyQuality of LifeChild, Only
Interventions
DIAGNOSTIC_TEST

Nasal cytology

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).

OTHER

The validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)

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.

OTHER

Total symptom score (TSS)

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

OTHER

Visual analogic scale (VAS)

A visual analogic scale (VAS) measured the parental perception of symptom severity (0=no symptom; 10=very severe symptoms).

Trial Locations (1)

80138

Second University, Naples

All Listed Sponsors
lead

University of Campania Luigi Vanvitelli

OTHER

NCT05301647 - Mometasone Furoate Nasal Spray in Italian Children | Biotech Hunter | Biotech Hunter