OBJECTIVE AND DESIGN: There is comparatively little information on asthma management in China. A multicentre, randomised, open-label, parallel-group, 6-week treatment study was conducted to evaluate the efficacy and safety of salmeterol/fluticasone propionate combination treatment in Chinese adult asthmatic patients. SETTING AND PATIENTS: 398 patients with a documented history of moderate-to-severe asthma were randomised to treatment. INTERVENTIONS:Salmeterol 50mug/fluticasone propionate 100mug twice daily for 6 weeks via Accuhaler((R)) (Diskustrade mark) inhaler and budesonide 400mug twice daily for 6 weeks via Turbuhaler((R)) inhaler. MAIN OUTCOME MEASURES AND RESULTS:Morning peak expiratory flow (PEF) was investigated as the primary efficacy endpoint; evening PEF, use of salbutamol (albuterol) as rescue medication, and day- and night-time asthma symptom scores were secondary efficacy endpoints. Safety was assessed according to adverse events recorded. Over the 6-week treatment period, salmeterol/fluticasone propionate led to a significantly greater increase in morning (p < 0.0001) and evening (p = 0.0066) PEF compared with budesonide. Moreover, the significant benefit of salmeterol/fluticasone propionate was evident from the first week. Similarly, salmeterol/fluticasone propionate led to significantly greater improvements in the use of rescue medication and day- and night-time asthma symptom scores, compared with budesonide. Both treatments were well tolerated, with a similar incidence (23%) of adverse events in both treatment groups and no serious adverse events. CONCLUSIONS:Salmeterol/fluticasone propionate 50mug /100mug twice daily was significantly more effective than budesonide 400mug twice daily in improving lung function and reducing symptoms and use of rescue medication in Chinese asthmatic patients who were poorly controlled on low-dose inhaled corticosteroids. This confirms the findings of superior efficacy of this combination product over budesonide in other populations.
RCT Entities:
OBJECTIVE AND DESIGN: There is comparatively little information on asthma management in China. A multicentre, randomised, open-label, parallel-group, 6-week treatment study was conducted to evaluate the efficacy and safety of salmeterol/fluticasone propionate combination treatment in Chinese adult asthmatic patients. SETTING AND PATIENTS: 398 patients with a documented history of moderate-to-severe asthma were randomised to treatment. INTERVENTIONS:Salmeterol 50mug/fluticasone propionate 100mug twice daily for 6 weeks via Accuhaler((R)) (Diskustrade mark) inhaler and budesonide 400mug twice daily for 6 weeks via Turbuhaler((R)) inhaler. MAIN OUTCOME MEASURES AND RESULTS: Morning peak expiratory flow (PEF) was investigated as the primary efficacy endpoint; evening PEF, use of salbutamol (albuterol) as rescue medication, and day- and night-time asthma symptom scores were secondary efficacy endpoints. Safety was assessed according to adverse events recorded. Over the 6-week treatment period, salmeterol/fluticasone propionate led to a significantly greater increase in morning (p < 0.0001) and evening (p = 0.0066) PEF compared with budesonide. Moreover, the significant benefit of salmeterol/fluticasone propionate was evident from the first week. Similarly, salmeterol/fluticasone propionate led to significantly greater improvements in the use of rescue medication and day- and night-time asthma symptom scores, compared with budesonide. Both treatments were well tolerated, with a similar incidence (23%) of adverse events in both treatment groups and no serious adverse events. CONCLUSIONS:Salmeterol/fluticasone propionate 50mug /100mug twice daily was significantly more effective than budesonide 400mug twice daily in improving lung function and reducing symptoms and use of rescue medication in Chinese asthmatic patients who were poorly controlled on low-dose inhaled corticosteroids. This confirms the findings of superior efficacy of this combination product over budesonide in other populations.
Authors: Christopher K W Lai; Teresita S De Guia; You-Young Kim; Sow-Hsong Kuo; Amartya Mukhopadhyay; Joan B Soriano; Pham Long Trung; Nan Shan Zhong; Norzila Zainudin; B M Z Zainudin Journal: J Allergy Clin Immunol Date: 2003-02 Impact factor: 10.793