Safety of Fluticasone Furoate Nasal spray among Filipino patients with Allergic Rhinitis: A post-marketing surveillance study

Introduction@#Allergic rhinitis (AR) is a highly prevalent chronic disease affecting up to 30% of the population worldwide.1 Although AR is not life-threatening, it greatly impacts patients’ health-related quality of life and furthermore, if left untreated, it may be complicated by other respiratory co-morbidities.2 Intranasal corticosteroids are one of the several classes of medications recommended to manage AR. Fluticasone furoate nasal spray is a novel enhancedaffinity glucocorticoid for the management of AR.2 This study assessed the safety profile of Fluticasone furoate nasal spray in the treatment of Filipino patients with AR.@*Methods@#This is a multicenter, prospective, post-marketing surveillance study aimed at documenting adverse events, their frequency and severity as assessed by the investigators among Filipino patients with AR administered with Fluticasone furoate nasal spray from August 2010 to January 2013.@*Results@#Four hundred thirty-nine (439) patients were enrolled in the study. Among these, 421 patients were included in the safety analysis population. Eighteen patients were excluded from the safety analysis population due to protocol violation and lack of post-baseline safety assessment. Of the total eligible population, 10 patients (2.4%) experienced adverse events (AEs) with a total of 10 and no serious adverse events (SAEs) were reported. Eight of these 10 AEs resolved while two AEs had unknown outcome. One patient (0.2%) experienced an AE suspected to be related to study medication. The most common AE occurring in eight patients was respiratoryrelated which were nasal dryness (3 events), rhinorrhea (2 events), epistaxis (1 event), nasal discomfort (1 event) and rhinalgia (1 event).@*Conclusion@#Fluticasone furoate nasal spray, among indicated patients with AR showed AEs which approximate AE of other similar post-marketing studies with incidence of less than 1% for each event.[21] Neither SAEs nor drugrelated deaths were reported throughout the study.

Clinical Study on Fluticasone Furoate Nasal Spray in the Treatment of Allergic Rhinitis / 中国药房

OBJECTIVE:To investigate clinical efficacy and safety of Fluticasone furoate nasal spray in the treatment of aller-gic rhinitis(AR). METHODS:100 AR patients in our hospital during Jan. 2014-Dec. 2015 were divided into control group and ob-servation group according to random number table,with 50 cases in each group. Both groups received decongestant Oxymetazoline hydrochloride spray. Control group was additionally given Budesonide spray,once each nostril on the first day,twice each nostril on the second day,increasing suitably according to disease condition,less than 6 times a day for patients younger than 14 years old,less than 8 times a day for patients older than 14 years old;observation group was additionally given Fluticasone furoate nasal spray,once each nostril,qd for patients younger than 14 years old,once each nostril,while morning and night for patients older than 14 years old. Both groups received treatment for consecutive 30 d. The total nasal symptoms score(TNSS),total eye symp-toms score (TESS),total nasal resistance (TNR) under 75,150 Pa,nasal minimum cross-sectional area (MCA) and the occur-rence of ADR were compared between 2 groups before and after treatment. RESULTS:There was no statistical significance in above indexes between 2 groups before treatment (P>0.05). After treatment,TNSS of 2 groups and TESS of observation group were decreased significantly compared to before treatment,and TESS of observation group was significantly lower than that of con-trol group,with statistical significance (P0.05). TNR of 2 groups under 75,150 Pa were significantly lower than before treatment,and the observation group was lower than the control group,with statistical significance (P0.05). The incidence of ADR in observation group was significant-ly lower than control group,with statistical significance(P<0.05). CONCLUSIONS:Fluticasone furoate is similar to budesonide in the treatment of nasal symptoms of AR patients,but it is better than budesonide in improving eye symptoms and nasal ventila-tion function with milder ADR.