PURPOSE:Asthma and seasonal allergic rhinitis often coexist and symptoms manifest concurrently. However, limited data is available regarding the role of fluticasone propionate/salmeterol (FSC) in this population. This study compared the effect of FSC vs montelukast (MON) on asthma control in subjects with active asthma and allergic rhinitis symptoms. In addition, this study was designed to evaluate whether fluticasone propionate aqueous nasal spray (FPANS) was superior to MON for control of allergic rhinitis in the presence of FSC.
METHODS:725 subjects (>15 years) with persistent asthma (FEV1 65–95%) and active seasonal allergic rhinitis received FSC 100/50mcg BID+FPANS 200mcg QD, FSC 100/50mcg BID+MON 10mg QD, FSC 100mcg/50mcg BID, or MON 10mg QD for 4 weeks during a pollen season.
RESULTS:Treatment with FSC produced significant improvements in AM PEF (primary outcome) vs MON [FSC: 26.4L/min; MON: 3.6L/min; p<0.001]. Secondary asthma measures (FEV1 [FSC: 0.148L; MON: 0.043L; p=0.010], symptom-free days [FSC: 34.8; MON: 26.1; p=0.017], and rescue-free days [FSC: 37.5; MON: 26.7; p=0.017]) significantly improved with FSC compared with MON monotherapy. FSC+FPANS was superior to FSC+MON (FSC+FPANS: -3.4; FSC+MON: -2.6; p≤;0.001) in improving daytime nasal symptom scores. The incidence of adverse events was similar among treatments.
CONCLUSION:In subjects with both asthma and allergic rhinitis, FSC was superior to MON in asthma control. FPANS provided superior daytime rhinitis symptom control vs MON in allergic asthma subjects treated with FSC.
CLINICAL IMPLICATIONS:These data suggest that optimal therapy for the individual conditions should be the goal of treatment for patients with coexistent allergic rhinitis and asthma. (ADA103575).
DISCLOSURE:John Oppenheimer, Employee Waitkus-Edwards, Prillaman and Ortega: GSK; Consultant fee, speaker bureau, advisory committee, etc. Oppenheimer and Mosnaim: GSK; No Product/Research Disclosure Information