Inhaled salmeterol and fluticasone: a study comparing monotherapy and combination therapy in asthma

Background: The current stepwise approach to pharmacotherapy in the treatment of asthma includes the initiation of an inhaled corticosteroid with the addition of a long-acting inhaled bronchodilator if low dose inhaled corticosteroid fails to control asthma symptoms. Objective: To determine whether initiation of salmeterol and fluticasone propionate treatment together improves asthma control greater than initiation of monotherapy with the individual agents alone with no additional safety risk in patients with asthma who had not previously been treated with inhaled corticosteroids. Methods: A total of 136 male and female patients at least 12 years of age with asthma [forced expiratory volume in 1 second (FEV1) between 50% and 80% of predicted] were randomized to twice daily salmeterol 42 mu g, fluticasone propionate 88 mu g, fluticasone propionate 220 mu g, salmeterol 42 mu g plus fluticasone propionate 88 mu g, salmeterol 42 mu g plus fluticasone propionate 220 mu g, or placebo for 4 weeks. Results: Patients treated with salmeterol combined with fluticasone propionate had improvements over baseline in FEV1 at endpoint that were at least twice as great (0.6 to 0.7 L) as improvements in patients treated with salmeterol (0.3 L) or fluticasone propionate alone (0.3 L) (P < .05). Patient-rated data (peak expiratory flow, asthma symptom scores, percent of days with no asthma symptoms) confirmed greater (P < .05) mean change from baseline improvements after combined treatment compared with fluticasone propionate alone. No clinically significant differences were noted between treatment groups in any safety measurement. Conclusion: Initiation of maintenance therapy with salmeterol and fluticasone propionate in patients with asthma treated with short-acting beta(2)-agonists alone provides greater improvements in pulmonary function and symptom control than initiation of maintenance therapy with fluticasone propionate alone.