Initiation of maintenance treatment with salmeterol/fluticasone propionate 50/100μg bd versus fluticasone propionate 100μg bd alone in patients with persistent asthma:: Integrated analysis of four randomised trials

To identify the asthma patients, on short-acting beta 2-agonists alone, who would benefit from initial maintenance therapy (IMT) with salmeterol/fluticasone (SFC) propionate 50/100 mu g bd compared with fluticasone propionate (FP) 100 mu g bd alone. The results of an integrated analysis of data from four previous trials are presented. Methods: The four original trials were randomised, double-blind, parallel group studies and included patients who had received IMT with SFC 50/100 mu g bd or FP 100 mu g bd. Patients were >= 12 years with a 6 month history of asthma and >= 15% reversibility in FEV1. Patients had either not received inhaled corticosteroids in the preceding month or were steroid naive. Patients were assessed to determine whether any GINA-defined asthma characteristics or combination of asthma characteristics could predict those individuals who would achieve well controlled asthma status with IMT with SFC rather than with inhaled steroid alone. Patients with persistent asthma were assessed based on GINA-defined baseline asthma characteristics and well controlled asthma status in response to each treatment was investigated according to combinations of these baseline features. Subsequently, a further range of endpoints, including asthma symptoms, rescue medication use and asthma control, were analysed over weeks 1-12 for the combinations of features where the treatment difference in well controlled asthma status was greatest. Results: The results of the initial analyses demonstrated that patients exhibiting two or three features of uncontrolled asthma at baseline were more likely to achieve well