Second University
Naples, 80138, Italy
NCT Number: NCT05301647
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.
Looking for future studies?
Notify Me4 year–12 year
All sexes
Observational
Naples, 80138, Italy
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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 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
A visual analogic scale (VAS) measured the parental perception of symptom severity (0=no symptom; 10=very severe symptoms).
Time frame: 2019-2021
The primary endpoint of this study was the change in eosinophilic mast cells and neutrophil infiltrate, assessed by nasal cytology
Time frame: 2019-2021
The secondary objective was the nasal symptom severity during the study assessed by total symptom score (TSS)
Time frame: 2019-2021
The secondary objective was the changes of quality of life during the study assessed by the validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)
University of Campania Luigi Vanvitelli
Other
Mometasone Furoate Nasal Spray in Italian Children With Seasonal Allergic Rhinitis: a Comprehensive Assessment
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03286049
Hypersensitivity, Hypersensitivity, Immediate
Palermo, Sicily, Italy
View Trial DetailsNCT06535087
Hypersensitivity, Hypersensitivity, Immediate
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT07283250
Air Pollution, Air Quality
Istanbul, Şişli, Turkey (Türkiye)
View Trial DetailsNCT07427576
Asthma, Bronchial Diseases
Santa Cruz de Tenerife, Canary Islands, Spain
View Trial Details