Safety of Fluticasone Furoate Nasal spray among Filipino patients with Allergic Rhinitis: A post-marketing surveillance study
- Author:
Joselito C. Javier
1
;
Sheila C. Chua
1
,
2
;
Giovell P. Barangan
1
,
3
Author Information
- Publication Type:Clinical Trial
- Keywords: Fluticasone furoate nasal spray; Filipino
- MeSH: Rhinitis, Allergic
- From: Philippine Journal of Internal Medicine 2018;56(1):48-55
- CountryPhilippines
- Language:English
-
Abstract:
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. - Full text:FINAL-2017-022_Safety.pdf
