Loss of asthma control when patients receiving fluticasone propionate/salmeterol 100/50μg Diskus® are “stepped-down” to fluticasone propionate, salmeterol or montelukast alone

Abstract

Rationale To determine if patients who are adequately controlled with fluticasone propionate/salmeterol 100/50μg (FSC) maintain control when therapy is “stepped-down” to fluticasone propionate (FP), salmeterol, or montelukast. Methods At baseline, patients had a mean FEV 1=2.3-2.4 L (69-70% predicted). Following a 2-week run-in on current ICS therapy, all patients received FSC 100/50μg BID for 4 weeks. Patients were then randomized to continue FSC (n=172) or “step-down” to FP 100μg BID (n=159), salmeterol 50μg BID (n=152), or montelukast 10mg QD (n=164) for 16 weeks. Prior to randomization, patients had a mean FEV 1=2.65-2.72L (79-80% predicted). Results Based upon AMPEF (primary endpoint), there were declines with all treatments except FSC (+4.4L/min) and AMPEF was significantly greater (p≤0.001) than FP, salmeterol and montelukast at endpoint (−16.8, −26.3, and −31.4L/min, respectively). Overall asthma control was significantly improved with FSC (p<0.019) relative to salmeterol and montelukast for all secondary endpoints including FEV 1, symptom- and rescue-free days and all secondary endpoints relative to FP, except symptom-free days (FSC vs. FP; p=0.083). Significantly more FSC recipients were satisfied or very satisfied with their therapy (77%; p<0.001) compared with 61% for FP, 47% for salmeterol and 32% for montelukast. Significantly fewer patients receiving FSC discontinued the study due to worsening asthma compared with FP, salmeterol and montelukast (p<0.001). Conclusions Once asthma control is achieved with FSC, “stepping-down” to FP, salmeterol or montelukast results in loss of asthma control. This study confirms that treatment of both inflammation and smooth muscle dysfunction is necessary to achieve and maintain optimal asthma control. (SAS40036)