Abstract
Background: Triple therapy using salmeterol/fluticasone propionate (SFC) and tiotropium bromide (TIO) is used to treat chronic obstructive pulmonary disease (COPD), but fewevidence have been published in Japanese COPD patients with a lower dose of inhaled corticosteroid.
Aims and Objectives: To compare the effects on lung function of triple therapy using SFC 50/250 mcg(SFC250) twice daily and TIO 18 mcg once daily with the individual treatments in Japanese COPD patients during a 4-week treatment period.
Methods: This was a randomised, double blind, crossover study. Patients were aged 40 - 80 years with a smoking history of >10 pack years, post bronchodilator forced expiratory volume in 1s (FEV1) ≥30% to ≤75% predicted normal, post bronchodilator FEV1/forced vital capacity (FVC) ratio <70%.The primary endpoint was post-dose specific airway conductance (sGaw) area under the curve (AUC0-4h) on day 28. Lung functions (sGaw, sRaw, forced expiratory volume in 1 sec (FEV1))were all assessed by plethysmography.
Results: Fifty threeCOPD patients participated. sGawAUC0-4h on day 28 was significantly higher following SFC250+TIO (0.854) compared with TIO (0.737, 15.8%, p<0.001) and SFC250 (0.663, 28.8%, p<0.001) alone. SFC250+TIO significantly improved trough FEV1 from baseline versus TIO (0.161 L p<0.001) and SFC50/250 mcg (0.103 L, p=0.008).
All treatments were tolerated with AEs reported by 33% (SFC250 and TIO), 16% (TIO) and 22% (SFC50/250) of patients.
Conclusion: These results suggested that triple therapy using SFC250 and TIO improves lung functions compared with the individual treatments and was tolerated in Japanese COPD patients.
- Copyright ©ERS 2015