A subgroup analysis in hispanic patients with allergic rhinitis of fluticasone propionate aqueous nasal spray for sinus pain and pressure caused by nasal congestion

Abstract

Rationale Sinus pain and pressure (SP+P) is a common symptom of allergic rhinitis. Fluticasone propionate aqueous nasal spray (FP) has been shown to reduce SP+P associated with allergies. Most research studies report findings for Caucasian and African American subgroups. Few research studies report findings for Hispanic patients, a growing population in the United States. Methods Two multi-center, double-blind, placebo-controlled, parallel-group studies compared daily dosing of FP 200μg (FP200QD) or placebo in 401 patients (age 12-74) with moderate-to-severe SP+P and nasal congestion. Of these, 115 Hispanic patients received either FP200QD (n=53) or placebo (n=62). Patients used a 100mm visual analog scale each evening to assess the severity of SP+P experienced over the day. Mean change from baseline for SP+P was determined over the 14-day treatment period. Descriptive statistics were displayed for the Hispanic subgroup and the magnitude of improvement was compared to the total population. Results Mean (SE) SP+P scores at baseline were similar for the total populations and Hispanic subgroups ranging from 71.0 (1.98) to 80.3 (2.10). Over the 14-day treatment period, mean changes (SE) from baseline in Study FNM40184 and FNM40185, respectively, were -19.6 (2.41) and -17.8 (2.10) for placebo compared with -26.4 (2.20) and -27.8 (2.41) for FP200QD in the total population (p<0.05 for each study). In the Hispanic subgroups, mean changes (SE) from baseline were -17.2 (4.15) and -21.8 (3.70) for placebo compared with -23.8 (4.44) and -27.0 (5.13) for FP200QD. Conclusions These studies suggest that FP200QD improves sinus pain and pressure in Hispanic patients with allergic rhinitis.