Mometasone Furoate Nasal Spray in Italian Children

NCT05301647 | Completed

• 1 other identifier: VANVCIT1
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

seasonal allergic rhinitis; mometasone furoate nasal spray; nasal cytology; type 2 inflammation; symptoms; quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Assesment of symptoms during the study

  2019-2021

• Assesment of quality of life changes during the study

  2019-2021

Study Arms (2)

Active 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)

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)

Interventions

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).

Active Group; Control Group

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.

Active Group; Control Group

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

Active Group; Control Group

Visual analogic scale (VAS) OTHER

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

Active Group; Control Group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Globally, 80 children were enrolled, but 76 (40 males and 36 females, mean age 11.4 + 3.3 years) completed the study. 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.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Second University

Naples, 80138, Italy

Location

Related Publications (18)

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MeSH Terms

Conditions

Rhinitis, Allergic; Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 31, 2022
• Study Start: June 20, 2019
• Primary Completion: September 20, 2021
• Study Completion: October 20, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)