Efficacy and safety of fluticasone propionate 44 μg/salmeterol 21 μg administered in a hydrofluoroalkane metered-dose inhaler as an initial asthma maintenance treatment

Background: We wanted to evaluate whether treatment with an inhaled corticosteroid and an inhaled long-acting beta(2)-agonist is more effective than an inhaled corticosteroid alone for patients using as-needed albuterol who are initiating maintenance treatment. Objective: To compare the efficacy and safety of twice-daily fluticasone propionate (FP) 88 mug and salmeterol 42 mug combined in a chlorofluorocarbon (CFC)-free (hydrofluoroalkane 134a) metered-dose inhaler (MDI) with the individual agents alone, each delivered through an MDI containing CFC propellants, in patient with persistent asthma previously uncontrolled with as-needed short-acting beta(2)-agonists alone. Methods: Patients with asthma (n = 283) were randomized to twice-daily treatment for 12 weeks with FP 88 mug combined with salmeterol 42 mug (FSC) in a CFC-free MDI or the individual components alone from CFC-containing MDIs. Results: At endpoint, mean change from baseline in morning predose forced expiratory volume in 1 second was significantly (P less than or equal to 0.016) greater with FSC (0.69 L) compared with FP (0.51 L) or salmeterol (0.47 L). Fewer patients treated with FSC withdrew due to worsening asthma (1%) compared with FP (3%) or salmeterol (8%; P = 0.024). FSC significantly increased (P less than or equal to 0.002) morning and evening peak expiratory flow rate at endpoint (66.5 and 51.5 L/min, respectively) compared with FP (43.0 and 29.9 L/min, respectively) and salmeterol (29.2 and 21.6 L/min, respectively). In addition, asthma symptom scores were reduced, and percentages of days with no asthma symptoms increased in all treatment groups. Conclusions: Treatment with FSC in a CFC-free MDI is more effective than FP or salmeterol alone in asthma patients who are symptomatic taking short-acting beta(2)-agonists alone.