From:  Combined intranasal treatment for allergic rhinitis: an option for children under 12 years of age

 Studies of combined nasal therapy in children under 12 years of age with allergic rhinitis.

AuthorAge (years)Number of patientsStudy groupsFollow-upEfficacy outcomesSafety outcomes
Berger et al. [14]4–11348 (304 children aged 6–11 years, 44 children < 6 years excluded for statistical analysis)AzeFlu (Aze 137 μg/Flu 50 μg) 1 puff in each nostril twice daily vs. placebo15 daysAverage QoL at day 15 decreased by –0.29 points in the AzeFlu group (p = 0.027).
Children with > 90% self-reported symptoms: fewer nasal (p = 0.002) and ocular (p = 0.009) symptoms; children with < 10% self-reported symptoms: no significant differences in symptoms.		No significant differences were found in AEs, most of which were mild (dysgeusia, epistaxis).
Berger et al. [15]6–11353AzeFlu vs. Flu (Aze 137 μg/Flu 50 μg) 1 puff in each nostril twice daily vs. Flu (50 μg) 1 puff in each nostril twice daily3 monthsAzeFlu group reduction of –0.68 points, Flu group reduction of –0.54 points (p = 0.04). The AzeFlu group controlled symptoms 16 days earlier than the Flu group.Not applicable.
Berger et al. [16]4–11404AzeFlu (Aze 137 μg/Flu 50 μg) 1 puff in each nostril twice daily vs. Flu (50 μg) 1 puff in each nostril twice daily3 monthsNot applicable.Incidence of AEs: AzeFlu (16%), Flu (13%). Epistaxis and headache were the most frequent AEs.
Prenner et al. [17]6–11446OloMom (Olo 665 μg/Mom 25 μg) 1 puff in each nostril twice daily vs. placebo14 daysThe OloMom group significantly improved individual symptom scores (p = 0.001), physician symptom scores (p < 0.01), and QoL scores (p < 0.001) compared to placebo.Treatment-related AEs: OloMom (12.0%) and placebo (10.4%): most common: dysgeusia, headache, epistaxis.
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QoL: quality of life; AEs: adverse effects; Aze: azelastine hydrochloride; Flu: fluticasone propionate; Olo: olopatadine hydrochloride; Mom: mometasone furoate; AzeFlu: Aze and Flu combination; OloMom: Olo and Mom combination.