Effectiveness of fluticasone furoate 110 μg once daily in the treatment of nasal and ocular symptoms of seasonal allergic rhinitis in adults and adolescents sensitized to mountain cedar pollen^*

ABSTRACT

Background: Fluticasone furoate (FF) is a novel enhanced-affinity corticosteroid for the treatment of allergic rhinitis, delivered by a unique side-actuated device. This study was designed to investigate the efficacy and safety of FF nasal spray (FFNS) 110 μg once daily compared with placebo in adults and adolescents (aged ≥12 years) with seasonal allergic rhinitis (SAR) symptoms caused by mountain cedar (Juniperus ashei) pollen.

Methods: This was a randomized, double-blind, placebo-controlled, parallel-group, phase III study conducted over a 2-week period (between 10 December 2004 and 19 January 2005) at seven study sites, in Austin, Texas, USA, and San Antonio, Texas, two metropolitan cities in the central Texas Hill Country located approximately 80 miles apart. Adult and adolescent patients (aged ≥12 years) with SAR, who were sensitized to mountain cedar (Juniperus ashei) pollen, were randomized to receive either FFNS 110 μg (n = 152) or placebo (n = 150) once daily. Patients rated the severity of each nasal symptom (rhinorrhea, nasal congestion, nasal itching, and sneezing) and ocular symptom (redness, watery eyes, itching and burning) on a 4-point categorical scale (0 = none, 3 = severe) in a reflective and instantaneous manner. Patients also rated their overall evaluation of response to therapy.

Results: FFNS significantly improved the nasal symptoms of SAR compared with placebo. The least square (LS) mean difference in the reflective total nasal symptom score (TNSS) was −0.777 (p = 0.003). A significant reduction in morning pre-dose instantaneous TNSS was also observed compared with placebo (LS mean difference −0.902; p < 0.001). Patients receiving FFNS had significantly greater improvements from baseline in reflective total ocular symptom scores (TOSS) than those receiving placebo (LS mean difference −0.546; p = 0.008). Significant improvements in ocular symptoms with FFNS versus placebo were also observed for morning pre-dose instantaneous TOSS (LS mean difference −0.519; p = 0.009). FFNS had a favorable safety and tolerability profile: fewer adverse events occurred with FFNS (22%) than with placebo (29%), and no serious adverse events were observed.

Conclusions: FFNS 110 μg once daily demonstrated efficacy in relieving both the nasal and ocular symptoms of SAR in adult and adolescent patients.

Trial registration: ClinicalTrials.gov identifier: NCT00115622.

Key words: :

• Fluticasone furoate
• Intranasal corticosteroids
• Juniperus ashei
• Mountain cedar
• Nasal spray
• Nasal symptoms
• Ocular symptoms
• Seasonal allergic rhinitis

Transparency

Declaration of funding

This study was funded by GlaxoSmithKline (Study FFR30003) and registered with ClinicalTrials.gov under Identifier NCT00115622. Employees of GlaxoSmithKline contributed to the interpretation and reporting of trial data in this manuscript.

Declaration of financial/other relationships

R.J. has disclosed that he has received grant/research funding from KCI USA, Schering-Plough, MedPointe Pharmaceuticals, Johnson & Johnson PRD, Inspire, Allied Research International, GlaxoSmithKline and sanofi-aventis. B.M. has disclosed that he has received grant/research funding from GlaxoSmithKline, sanofi-aventis, Allied Research International, Sepracor, MedPointe Pharmaceuticals, Schering-Plough, UCB, AstraZeneca and Merck. F.H. has disclosed that he has no relevant financial relationships. W.T., A.E. and E.P. have disclosed that they are employees of GlaxoSmithKline.

All peer reviewers receive honoraria from CMRO for their review work. Peer Reviewer 1 and Peer Reviewer 2 have disclosed that they have no relevant financial relationships.

Acknowledgments

Financial support for medical editorial assistance was provided by GlaxoSmithKline. The authors thank the FFR30003 GSK study team for their contribution and the editorial assistance of Sian Kneller, MSc, and Susan Cheer, PhD, Innovex Medical Communications, in the development and author review of this manuscript.

Notes

* Data from this study were presented in abstract and poster format at the American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting, held in San Diego, CA, USA, 23–27 February 2007