Mometasone Furoate Nasal Spray in Italian Children

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05301647
• Other study ID #: VANVCIT1
• Status: Completed
• Start date: June 20, 2019
• Est. completion date: October 20, 2021

Study information

• Verified date: March 2022
• Source: University of Campania "Luigi Vanvitelli"
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 20, 2021
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergy Pollen
• Child, Only
• Hypersensitivity
• Nasal Allergy
• Quality of Life
• Rhinitis
• Rhinitis, Allergic

Intervention

Diagnostic Test:
• Nasal cytology
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).

Other:
• The validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)
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)
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)
A visual analogic scale (VAS) measured the parental perception of symptom severity (0=no symptom; 10=very severe symptoms).

Locations

Country	Name	City	State
Italy	Second University	Naples

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

References & Publications (18)

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Ciprandi G, Tosca MA, Passalacqua G, Canonica GW. Intranasal mometasone furoate reduces late-phase inflammation after allergen challenge. Ann Allergy Asthma Immunol. 2001 Apr;86(4):433-8. — View Citation

Ciprandi G, Varricchio A. The relevance of the Mometasone furoate nasal spray in clinical practice. J Biol Regul Homeost Agents. 2018 Jul-Aug;32(4):1051-1054. — View Citation

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Madison S, Brown EA, Franklin R, Wickersham EA, McCarthy LH. Clinical Question: Nasal saline or intranasal corticosteroids to treat allergic rhinitis in children. J Okla State Med Assoc. 2016 Apr-May;109(4-5):152-3. Review. — View Citation

Meltzer EO, Baena-Cagnani CE, Gates D, Teper A. Relieving nasal congestion in children with seasonal and perennial allergic rhinitis: efficacy and safety studies of mometasone furoate nasal spray. World Allergy Organ J. 2013 Mar 4;6(1):5. doi: 10.1186/193 — View Citation

Meltzer EO, Shekar T, Teper AA. Mometasone furoate nasal spray for moderate-to-severe nasal congestion in subjects with seasonal allergic rhinitis. Allergy Asthma Proc. 2011 Mar-Apr;32(2):159-67. doi: 10.2500/aap.2011.32.3424. — View Citation

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Wise SK, Lin SY, Toskala E, Orlandi RR, Akdis CA, Alt JA, Azar A, Baroody FM, Bachert C, Canonica GW, Chacko T, Cingi C, Ciprandi G, Corey J, Cox LS, Creticos PS, Custovic A, Damask C, DeConde A, DelGaudio JM, Ebert CS, Eloy JA, Flanagan CE, Fokkens WJ, F — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assesment of symptoms during the study	The secondary objective was the nasal symptom severity during the study assessed by total symptom score (TSS)	2019-2021
Secondary	Assesment of quality of life changes during the study	The secondary objective was the changes of quality of life during the study assessed by the validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)	2019-2021