Efficacy of theophylline plus salmeterol/fluticasone propionate combination therapy in patients with asthma

Summary Objective To compare the efficacy of theophylline plus salmeterol/fluticasone propionate combination product (SFC) with SFC plus placebo in asthmatic patients. Methods In this randomized, stratified, parallel-group study, 325 patients were randomized to receive either 200 mg theophylline plus 50/250 μg SFC or placebo tablet plus 50/250 μg SFC twice daily for 24 weeks. Outcome variables included the level of asthma control (assessed by the Asthma Control Test) and the number of patients experiencing ≥1 exacerbations during the 24-week treatment period. Testing of lung function as well as measurement of the levels of inflammatory markers in induced sputum was performed. Results There were significantly fewer patients with ≥1 asthma exacerbation in the theophylline plus SFC group (29.6%) when compared with the SFC plus placebo group (46.9%) ( p = 0.004). Theophylline plus SFC improved the FEF25–75% value, which indicates enhanced small airway function, to a greater extent than SFC plus placebo (66.9 ± 18.8% and 57.4 ± 17.6%, respectively; p