METHODS: Randomized single-blind trial to compare the outcomes of FLU/AZE, Fluticasone propionate (FLU) and Azelastin hydrochloride (AZE), 1 puff per nostril each bid for four weeks in 6 year-old children with AR. All patients had total nasal score symptom (TNSS) ≥ 8 (moderate to severe AR) and positive SPT to D. pteronyssinus (Dp) extract. SPT were carried on with histamine 10mg/mL and Dp 10000 PNU/mL and saline. TNSS and SPT were performed before (V1) and after (V2) four weeks of treatment.
RESULTS: Forty-five patients, 63% male, mean age11.3±1.7 years, were randomized to FLU/AZE (n=15), FLU (n=13) and AZE (n=15). One children dropped-out and other did not show up V2 in the FLU group. After four weeks, the mean TNSS reduction was higher in FLU/AZE group (58.2%) than FLU (48.2%) and AZE (44.4%) groups (p=0.02). The mean wheal size reduction in the SPT for histamine was higher in the FLU/AZE group (31.3%) than FLU (13.2%) and AZE (27.3%) groups (p=0.0008). There were no difference between groups in mean wheal size reduction for Dp, FLU/AZE (36.4%), FLU (21.7%) and AZE (31.6%), (p=0.09).
the association of intranasal FLU/AZE was more effective than intranasal corticosteroids or anti-histamine isolated, and promote more SPT inhibition in children.