Clinical trial NCT05301647: Mometasone Furoate Nasal Spray in Italian Children
Official title: Mometasone Furoate Nasal Spray in Italian Children With Seasonal Allergic Rhinitis: a Comprehensive Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in eosinophils, mast cells and neutrophil infiltrate by nasal cytology after the treatment
timeFrame: 2019-2021
Secondary outcomes:
measure: Assesment of symptoms during the study
timeFrame: 2019-2021
measure: Assesment of quality of life changes during the study
timeFrame: 2019-2021
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Second University
Study officials:
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