Efficacy and Safety of Inhalation of Budesonide/Formoterol via Turbuhaler® in Chinese Patients With Chronic Obstructive Pulmonary Diseas

Abstract

PURPOSE: Inhaled budesonide (BUD)/formoterol (FORM) via Turbuhaler were widely used in the treatment of asthma, but less in COPD, and no report for Chinese COPD patients. This study was designed to evaluate the efficacy and safety of BUD/FORM Turbuhaler compared with BUD Turbuhaler in Chinese patients with COPD. METHODS: This was a 6-month, multicenter, randomized, parallel-group, doubleblind, double-dummy study. Patients were randomized to either: BUD/FORM 160/4.5 Cg, two inhalations twice daily, or BUD 200Cg, two inhalations twice daily. Improvement of lung function, daily symptoms, reliever use and health-related quality-of-life (St George's Respiratory Questionnaire [SGRQ] score) were compared. RESULTS: 308 Chinese patients with moderate to very severe COPD were randomized in 12 centers (BUD/FORM group, n=156; BUD group, n=152). 1-hour post-dose FEV1 in BUD/FORM group was improved by 0.17 L (from 0.83 L to 1.01 L), significantly better (p<0.001) than the improvement (0.03 L) observed in the BUD group after 24 weeks' treatment. Increases in pre-dose and 15-min postdose FEV1 together with 1-hour post-dose FVC were significantly larger with BUD/FORM than BUD (p<0.001 for all). Compared with BUD alone, BUD/FORM improved COPD symptom total scores (-0.55+0.17 vs. -1.04+0.16; p=0.03), reduced reliever use (-0.31+0.16 puffs/day vs. -0.85+0.16 puffs/day; p=0.012) and improved total SGRQ score -4.5 points (p=0.0182). Overall, both treatments were well tolerated. CONCLUSIONS: Fixed combination treatment with BUD/FORM via Turbuhaler resulted in clinically meaningful improvements compared with BUD alone for lung function, quality-of-life, COPD symptoms and a reduction in reliever use, and it was well tolerated. CLINICAL IMPLICATIONS: The benefits of BUD/FORM to treat Chinese patients with COPD were similar to other ethnic populations, and the improvement of health statues might be better in Chinese patients with COPD.