BACKGROUND:Seasonal allergic rhinitis is a common and distressing illness for which treatment is often inadequate. There is a clinical need for safe and effective therapeutic options, including preseasonal treatment, to manage many of these patients. OBJECTIVE: The goal of this study was to evaluate the clinical effects of preseasonal administration of triamcinolone acetonide nasal aerosol in the management of this illness. METHODS: This multicenter, double-blind, placebo-controlled, randomized, parallel group study involved otherwise healthy subjects with a 2-year consecutive history of ragweed-induced seasonal allergic rhinitis. Patients were asymptomatic when randomized to receive 220 micrograms triamcinolone acetonide or placebo nasal aerosol (n = 56 each) once daily for 6 weeks, beginning at least 1 week before significant ragweed pollen was airborne. RESULTS:Triamcinolone acetonide was significantly (P < .001) more effective than placebo in preventing nasal symptoms as determined by mean placebo-adjusted nasal index scores. Patients in the triamcinolone acetonide group had significantly (P < or = .0004) lower scores in the severity of individual nasal symptoms and the overall mean nasal index score. Severity of ocular symptoms was reduced more in the triamcinolone acetonide than in the placebo group (not significant). Physicians' and patients' global evaluations of efficacy favored triamcinolone acetonide, with statistically significant between-group differences in moderate or complete prevention of rhinitis symptoms. The incidence of adverse effects was similar in the two groups, with the most common being headache and increased rhinitis. CONCLUSIONS: This study demonstrates that preseasonal administration of triamcinolone acetonide nasal aerosol is safe and effective for managing seasonal allergic rhinitis.
RCT Entities:
BACKGROUND:Seasonal allergic rhinitis is a common and distressing illness for which treatment is often inadequate. There is a clinical need for safe and effective therapeutic options, including preseasonal treatment, to manage many of these patients. OBJECTIVE: The goal of this study was to evaluate the clinical effects of preseasonal administration of triamcinolone acetonide nasal aerosol in the management of this illness. METHODS: This multicenter, double-blind, placebo-controlled, randomized, parallel group study involved otherwise healthy subjects with a 2-year consecutive history of ragweed-induced seasonal allergic rhinitis. Patients were asymptomatic when randomized to receive 220 micrograms triamcinolone acetonide or placebo nasal aerosol (n = 56 each) once daily for 6 weeks, beginning at least 1 week before significant ragweed pollen was airborne. RESULTS:Triamcinolone acetonide was significantly (P < .001) more effective than placebo in preventing nasal symptoms as determined by mean placebo-adjusted nasal index scores. Patients in the triamcinolone acetonide group had significantly (P < or = .0004) lower scores in the severity of individual nasal symptoms and the overall mean nasal index score. Severity of ocular symptoms was reduced more in the triamcinolone acetonide than in the placebo group (not significant). Physicians' and patients' global evaluations of efficacy favored triamcinolone acetonide, with statistically significant between-group differences in moderate or complete prevention of rhinitis symptoms. The incidence of adverse effects was similar in the two groups, with the most common being headache and increased rhinitis. CONCLUSIONS: This study demonstrates that preseasonal administration of triamcinolone acetonide nasal aerosol is safe and effective for managing seasonal allergic rhinitis.
Authors: Martti Anton Antila; Fabio Morato Castro; Flavio Sano; Adelmir Machado; Fatima Fernandes; Nelson Augusto Rosário Filho; Rafael Stelmach Journal: Braz J Otorhinolaryngol Date: 2016-02-15