Comparison of fluticasone/formoterol with budesonide/formoterol pMDI in adults with moderate to severe persistent asthma: Results from a 12-week randomized controlled trial.

BACKGROUND: Combination therapy of inhaled corticosteroid/long acting ß2-agonist (ICS/LABA) is the cornerstone of managing asthmatics who are uncontrolled with low-medium dose of ICS. The novel ICS/LABA combination of fluticasone propionate and formoterol (flu/form) provides potent anti-inflammatory and rapid bronchodilatory effect. This randomized, multi-centre, double-blind study compared the efficacy and safety of flu/form (125/6 mcg BD; Maxiflo®) with the well-established budesonide/formoterol combination (bud/form 200/6 mcg BD), both delivered through a pressurized metered dose inhaler (pMDI) in patients with moderate to severe persistent asthma over 12 weeks. METHODS: This study enrolled patients between 18 and 65 years. The primary end-point was to demonstrate non-inferiority for the mean change in the pre-dose morning peak expiratory flow values (PEF). The secondary end-points included lung function assessments, number of symptom-free days and nights, rescue medication use, day-and night-time symptom scores and safety evaluation. RESULTS: Two hundred and thirty-two patients were randomized to either flu/form (n = 117) or bud/form (n = 115). At the end of 12 weeks, flu/form was non-inferior to bud/form with regards to the primary end-point of morning PEF (48.07 L/min vs. 49.03 L/min, p > 0.05). These improvements were statistically significant (p < 0.0001) vs baseline. Similar improvements were observed between the two groups for secondary efficacy end-points including FEV1, symptom-free nights, rescue medication use, day-and night-time symptom scores (p > 0.05). Flu/form exhibited a safety profile comparable to that of bud/form. CONCLUSION: Fluticasone/formoterol combination administered through a pMDI is as efficacious and well-tolerated as budesonide/formoterol and offers a new therapeutic option for patients with moderate to severe persistent asthma.