Meng-Jer Hsieh1, Yu-Ching Lin2, Ruay-Sheng Lai3, Chien-Liang Wu4, Chun-Liang Lai5, Chin-Chou Wang6, Diahn-Warng Perng7, Shang-Jyh Kao8, En-Ting Chang9, Hao-Chien Wang10, Wann-Cherng Perng11, Jeng-Yuan Hsu12, Ching-Hsiung Lin13, Ying-Huang Tsai14. 1. Department of Pulmonary and Critical Care Medicine, Chia-Yi Chang-Gung Memorial Hospital, Chang-Gung Medical Foundation, Taiwan; Department of Respiratory Therapy, School of Medicine, Chang-Gung University, Taiwan. 2. Department of Pulmonary and Critical Care Medicine, Chia-Yi Chang-Gung Memorial Hospital, Chang-Gung Medical Foundation, Taiwan. 3. Division of Chest Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan. 4. Division of Chest Medicine, Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan. 5. Division of Pulmonology and Critical Care, Department of Internal Medicine, Dalin Tzu Chi Hospital, Chiayi, Taiwan; School of Medicine, Tzu Chi University, Hualien, Taiwan. 6. Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang-Gung Medical Foundation, Taiwan. 7. Department of Chest Medicine, Taipei Veterans General Hospital, Taipei, Taiwan. 8. Division of Pulmonary Medicine, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan. 9. Department of Chest Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan; School of Medicine, Tzu Chi University, Hualien, Taiwan. 10. Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. 11. Division of Pulmonary and Critical Care Medicine, Department of Medicine, Tri-Service General Hospital, Taiwan. 12. Division of Chest Medicine, Taichung Veterans General Hospital, Taiwan. 13. Division of Chest Medicine, Department of Internal Medicine, Changhua Christian Hospital, Changhua 500, Taiwan. 14. Department of Pulmonary and Critical Care Medicine, Chia-Yi Chang-Gung Memorial Hospital, Chang-Gung Medical Foundation, Taiwan; Department of Respiratory Therapy, School of Medicine, Chang-Gung University, Taiwan. Electronic address: chestmed@cgmh.org.tw.
Abstract
BACKGROUND: The study was designed to compare the efficacy and tolerability of a fixed combination of extra-fine beclomethasone and formoterol, with the fixed combination fluticasone and salmeterol in Taiwanese asthmatic patients. METHODS: This was a phase III, multicentre, randomized, two-arm parallel groups, controlled study. Patients with moderate to severe asthma were randomized to a 12-week treatment with either beclomethasone 100 mcg plus formoterol 6 mcg (BDP/F) or fluticasone 125 mcg plus salmeterol 25 mcg (FP/S), both delivered 2 inhalations twice daily. The efficacy and tolerability of these two combinations were compared. RESULTS: Among the 253 randomized subjects, 244 patients were evaluable (119 in the BDP/F group and 125 in the FP/S group). A significant improvement from baseline to the end of treatment period was observed in both BDP/F and FP/S groups in forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), morning and evening peak expiratory flow (PEF), Asthma Control Test (ACT) score and the use of rescue medication. FVC increase from pre-dose was significant after 5 min post inhalation in the BDP/F group only, while statistically significant within group improvement was not achieved until 30 min post inhalation in the FP/S group. CONCLUSION: The BDP/F combination is comparable in efficacy and tolerability to FP/S combination in Taiwanese asthmatic patients, with the advantage of rapid onset of improvement of FVC, consistent with the faster improvement of pulmonary hyperinflation with BDP/F.
RCT Entities:
BACKGROUND: The study was designed to compare the efficacy and tolerability of a fixed combination of extra-fine beclomethasone and formoterol, with the fixed combination fluticasone and salmeterol in Taiwanese asthmatic patients. METHODS: This was a phase III, multicentre, randomized, two-arm parallel groups, controlled study. Patients with moderate to severe asthma were randomized to a 12-week treatment with either beclomethasone 100 mcg plus formoterol 6 mcg (BDP/F) or fluticasone 125 mcg plus salmeterol 25 mcg (FP/S), both delivered 2 inhalations twice daily. The efficacy and tolerability of these two combinations were compared. RESULTS: Among the 253 randomized subjects, 244 patients were evaluable (119 in the BDP/F group and 125 in the FP/S group). A significant improvement from baseline to the end of treatment period was observed in both BDP/F and FP/S groups in forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), morning and evening peak expiratory flow (PEF), Asthma Control Test (ACT) score and the use of rescue medication. FVC increase from pre-dose was significant after 5 min post inhalation in the BDP/F group only, while statistically significant within group improvement was not achieved until 30 min post inhalation in the FP/S group. CONCLUSION: The BDP/F combination is comparable in efficacy and tolerability to FP/S combination in Taiwanese asthmatic patients, with the advantage of rapid onset of improvement of FVC, consistent with the faster improvement of pulmonary hyperinflation with BDP/F.