Efficacy and safety of tiotropium bromide combined with budesonide/formoterol in the treatment of moderate to severe chronic obstructive pulmonary disease.

With the increase of environmental pollution, chronic obstructive pulmonary disease (COPD) has become a serious health threat. In the present study, the efficacy and safety of inhalation therapy of tiotropium bromide combined with budesonide/formoterol were assessed in 180 patients with moderate to severe COPD (clinical trial registry no. ChiCTR1800017584). Patients were treated by inhalation of budesonide/formoterol (control group) or inhalation of tiotropium bromide combined with budesonide/formoterol (intervention group). The results indicated that after the treatment, the forced expiratory volume in 1 sec, the modified Medical Research Council scale, the 6-min walking distance and the St. George's Respiratory Questionnaire scores for quality of life were significantly improved in the two groups, while the improvements in the intervention group were more significant (all P<0.05). There was no significant difference in body mass indices between the two groups during the course of the treatment (P=0.302). The difference in the risk of an acute exacerbation between the two groups was also not significant (P=0.238). The median time to the first acute exacerbation from the start of treatment in the intervention group (53 days; 25% quartile, 50 days; 75% quartile, 62 days) was significantly longer than that in the control group (37 days; 25% quartile, 23 days; 75% quartile, 39 days; P=0.042). The adverse reaction rates in the intervention and control groups were 14.4 and 10.0%, respectively, without any significant difference. In conclusion, inhalation treatment of tiotropium bromide combined with budesonide/formoterol significantly improves pulmonary function, exercise capacity and quality of life of patients with COPD compared with budesonide/formoterol inhalation alone, while the effect of reducing the acute attack risk requires further evaluation.