Mometasone Furoate Nasal Spray in Italian Children

Sponsor

University of Campania "Luigi Vanvitelli" (Other)

Overall Status

Completed

CT.gov ID

NCT05301647

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rhinitis, Allergic Nasal Allergy Allergy Pollen Nasal, Cytology Mometasone Allergy Quality of Life Child, Only	Diagnostic Test: Nasal cytology Other: The validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Other: Total symptom score (TSS) Other: Visual analogic scale (VAS)

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

80 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 20, 2019

Actual Primary Completion Date :

Sep 20, 2021

Actual Study Completion Date :

Oct 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Group	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).
Control Group	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).

Arm

Intervention/Treatment

Active Group

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).

Control Group

Diagnostic Test: Nasal cytology

Other: The validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)

Other: Total symptom score (TSS)

Other: Visual analogic scale (VAS)

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

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.