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, double-blind, double-dummy study. Patients were randomized to either: BUD/FORM 160/4.5 μg, two inhalations twice daily, or BUD 200μg, 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 post-dose 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.
DISCLOSURE: The following authors have nothing to disclose: Nanshan Zhong, Jinping Zheng, Fuqiang Wen, Lan Yang, Ping Chen, Qingyu Xiu, Wanzhen Yao, Tieying Sun, Ziwen Zhao, Huahao Shen, Yi Shi, Jiangtao Lin, Qiang Li
In order to reduce the interference of the trial and prove the efficacy of these bronchodilators,we used the products from AstraZeneca to evaluate the difference bewteen inhaling BUD/FORM(Symbicort Turbuhaler) and BUD(Pulmicort Turbuhaler), two different version of the same product, rather than commercial purpose.