Mometasone Furoate Nasal Spray in Italian Children

University of Campania "Luigi Vanvitelli"

Status: Completed

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

Treatments: Other: Total symptom score (TSS); Other: The validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ); Other: Visual analogic scale (VAS); Diagnostic Test: Nasal cytology

Study type: Observational

Funder types: Other

Identifiers

NCT05301647

VANVCIT1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

80 participants in 2 patient groups

Active Group

Treatment:

Other: Visual analogic scale (VAS)

Diagnostic Test: Nasal cytology

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

Other: Total symptom score (TSS)

Control Group

Treatment:

Other: Visual analogic scale (VAS)

Diagnostic Test: Nasal cytology

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

Other: Total symptom score (TSS)