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Completed

NCT Number: NCT05301647

Mometasone Furoate Nasal Spray in Italian Children

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nasal cytology

Diagnostic Test

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).

The validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)

Other

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 (TSS)

Other

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

Visual analogic scale (VAS)

Other

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

Primary outcomes

  1. Change in eosinophils, mast cells and neutrophil infiltrate by nasal cytology after the treatment

    Time frame: 2019-2021

    The primary endpoint of this study was the change in eosinophilic mast cells and neutrophil infiltrate, assessed by nasal cytology

Secondary outcomes

  1. Assesment of symptoms during the study

    Time frame: 2019-2021

    The secondary objective was the nasal symptom severity during the study assessed by total symptom score (TSS)

  2. Assesment of quality of life changes during the study

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 31, 2022
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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