Efficacy and Tolerability of Salmeterol/Fluticasone Propionate versus Fluticasone Propionate in Asthma Patients: A Randomized, Double-blind Study

Background: A combination of salmeterol and fluticasone propionate (SAL/FP) has beenshown to be effective in the treatment of asthma. We compared the efficacyand tolerability of SAL/FP (50/250 μg) with fluticasone propionate (FP)250 μg administrated twice daily for 2 weeks in treating patients with mild tomoderate asthma.Methods: This was a randomized, double-blind study in adult patients with symptomatic asthma that was not controlled by 1000 μg/d inhaled corticosteroids(ICS) alone. 48 asthmatics were randomized to receive 2 inhalations ofSAL/FP 50/250 μg bis in die (BID) or 2 inhalations of FP 250 μg BID, bothdelivered via Accuhaler device, for 2 weeks. The primary objective was themean change from baseline in the mean morning peak expiratory flow (PEF)over the two week period. Other parameters included lung function, dailyasthma symptom scores, evening PEF, percentage of days free of rescuemedication use and daily rescue medication use. Tolerability was assessed byadverse events spontaneously elicited at clinic visits.Results: 46 patients provided evaluable efficacy for analysis. The morning PEFimproved significantly throughout the two weeks of treatment comparedwith baseline in the SAL/FP group. Mean morning PEF was 23.0 L/minhigher in SAL/FP group than in FP group (p = 0.013). The change of forcedexpiratory volume in one second (FEV1) from baseline was greater inSAL/FP group compared to FP group (p = 0.048). There were similar effectson day-time and night-time symptom scores, percentage symptom free daysand nights and usage of salbutamol. 70.8% of the patients receiving SAL/FPwere satisfied with the treatment, while only 26.1% of patients receiving FPalone were (p = 0.020). No death or acute exacerbation occurred.Conclusion: SAL/FP 50/250 μg was safe and effective, and had a high level of patientsatisfaction resulting in significantly greater increases in morning PEF andFEV1 compared to the use of FP 250 μg alone