In patients taking fluticasone propionate/salmeterol 100/50[mu]g Diskus® for asthma, the addition of fluticasone propionate nasal spray 200[mu]g QD to treat concomitant allergic rhinitis has a safety profile comparable to the addition of montelukast 10mg QD or placebo

• Published in: Journal of allergy and clinical immunology 2004-02, Vol.113 (2), p.S202
• Main Authors: Nathan, RA, Philpot, E, Faris, M, Prillaman, B, Yancey, S, Dorinsky, P
• Format: Article
• Language: English
• ISSN: 0091-6749; 1097-6825
• DOI: 10.1016/j.jaci.2004.01.173

Rationale When a patient has coexistent asthma and allergic rhinitis, optimal management of the individual diseases should be the treatment goal. However, there are limited data comparing the safety of concurrent treatment with inhaled corticosteroids and either an intranasal corticosteroid or a nonsteroidal rhinitis controller. Methods This 4-week study included a comparison of the safety profiles of fluticasone propionate nasal spray (FPNS), montelukast (MON) and placebo when added to fluticasone propionate/salmeterol 100/50μg BID (FSC) in 863 patients (>=15 years) with symptomatic seasonal allergic rhinitis and persistent asthma. Safety assessments included adverse event monitoring and 24-hour urinary cortisol measurement at baseline and endpoint. Results Both FPNS+FSC and MON+FSC were well tolerated. The overall incidence of all adverse events for FPNS+FSC and MON+FSC was similar to placebo+FSC. There were no differences in the incidence or type of drug related adverse events across the three treatment groups. Importantly, urinary cortisol excretion during treatment with FPNS+FSC was similar to that observed with MON+FSC and Placebo+FSC. Conclusions In patients with asthma and allergic rhinitis taking FSC, concurrent treatment with FPNS is as safe as treatment with MON or placebo and does not lead to an increased risk for HPA axis suppression. These data suggest there is no safety advantage in using a nonsteroidal rhinitis controller versus an intranasal corticosteroid concurrently with an inhaled corticosteroid.