Mometasone Furoate Nasal Spray in Italian Children

Last updated: March 19, 2022
Sponsor: University of Campania "Luigi Vanvitelli"
Overall Status: Completed

Phase

N/A

Condition

Rhinitis, Allergic, Perennial

Acute Rhinitis

Allergy

Treatment

N/A

Clinical Study ID

NCT05301647
VANVCIT1
  • Ages 4-12
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Exclusion criteria were: perennial AR, rhinitis due to other causes, concomitant acuteor chronic rhinosinusitis, nasal polyps, asthma comorbidity, current use of topical orsystemic corticosteroids, antihistamines, antileukotrienes, inadequate washout ofthem, nasal anatomic defect, respiratory infections in the last two weeks,participation in other clinical studies in the previous month, documentedhypersensitivity to the study product or its excipients, and trip planned outside ofthe study area.

Study Design

Total Participants: 80
Study Start date:
June 20, 2019
Estimated Completion Date:
October 20, 2021

Study 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.

Connect with a study center

  • Second University

    Naples, 80138
    Italy

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.