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Allergic Rhinitis in Children: A Randomized Clinical Trial Targeted at Symptoms
Nicola Mansi1, Gabriele D'Agostino1, Antonella Silvia Scirè2
1S.C. di Otorinolaringoiatria della A.O.R.N. Santobono Pausilipon di Napoli, Naples, Italy.
Insights
Narivent(®) effectively managed allergic rhinitis symptoms like nasal congestion in children over 30 days. It demonstrated comparable efficacy to topical corticosteroids but with an improved safety profile for pediatric patients.
Area of Science:
- Pediatric Allergy and Immunology
- Otolaryngology
- Medical Device Research
Background:
- Allergic rhinitis (AR) significantly impacts children's quality of life.
- Effective symptomatic management is crucial for pediatric patients.
- Current treatments include topical corticosteroids, with varying safety profiles.
Purpose of the Study:
- To evaluate the efficacy and safety of Narivent(®) compared to topical corticosteroids for AR symptom management in children.
- To assess the impact of Narivent(®) on key AR symptoms including nasal congestion, rhinorrhoea, sneezing, and nasal itching.
- To determine if Narivent(®) offers a favorable safety profile in pediatric AR treatment.
Main Methods:
- A randomized, two-arm study involving 40 pediatric patients diagnosed with AR.
- Participants received either Narivent(®) or topical intranasal corticosteroids (one puff per nostril, twice daily for 30 days).
- Symptom severity was subjectively assessed using a 0-100 mm visual analogue scale.
Main Results:
- Narivent(®) treatment led to significant improvements in nasal congestion, rhinorrhoea, and sneezing after 30 days.
- Topical corticosteroids also significantly reduced the severity of all assessed subjective symptoms.
- Narivent(®) showed comparable efficacy to intranasal corticosteroids in managing major AR symptoms.
Conclusions:
- Narivent(®) is effective for treating nasal congestion and other major symptoms in children with AR over a 30-day period.
- The medical device demonstrated comparable results to intranasal corticosteroids.
- Narivent(®) presents a potentially better safety profile for pediatric AR management.
Abstract:
Allergic rhinitis (AR) underlies many symptoms and complications which severely affect children's quality of life. This two-arm study aimed at evaluate the efficacy and safety of the medical device Narivent(®) versus topical corticosteroids in the symptomatic management of allergic rhinitis in paediatric patients. A randomized study was conducted. Forty subjects with a diagnosis of allergic rhinitis were randomized to receive one puff of Narivent(®) into each nostril twice daily for 30 days (n = 20) or to receive one puff of topical intranasal corticosteroid into each nostril twice daily for 30 days (n = 20). In both treatment arms, severity of major symptoms related to AR, including nasal congestion, rhinorrhoea, sneezing and nasal itching, was assessed subjectively on a 0-100 mm visual analogue scale. Nasal congestion, rhinorrhoea and sneezing improved significantly after 30 days of treatment with Narivent(®). Similarly, in topical steroids group severity of all subjective symptoms decreased significantly. Narivent(®) appears to be efficacious in treating nasal congestion and other major symptoms in children with AR over a 30-day period, showing comparable results to intranasal corticosteroids therapy but with a better safety profile.
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