Comparative efficacy and tolerability of beclomethasone/formoterol and fluticasone/salmeterol fixed combination in Taiwanese asthmatic patients

Meng Jer Hsieh, Yu Ching Lin, Ruay Sheng Lai, Chien Liang Wu, Chun Liang Lai, Chin Chou Wang, Diahn Warng Perng, Shang Jyh Kao, En Ting Chang, Hao Chien Wang, Wann Cherng Perng, Jeng Yuan Hsu, Ching Hsiung Lin, Ying Huang Tsai

Research output: Contribution to journalArticle

2 Citations (Scopus)

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. Conclusions: 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.

Original languageEnglish
JournalJournal of the Formosan Medical Association
DOIs
Publication statusAccepted/In press - Jan 1 2017

Fingerprint

Beclomethasone
Vital Capacity
Inhalation
Asthma
Forced Expiratory Volume
Lung
Formoterol Fumarate
Salmeterol Xinafoate Drug Combination Fluticasone Propionate
Therapeutics

Keywords

  • Asthma
  • Combination therapy
  • Inhaled corticosteroid
  • Long acting beta2-agonist
  • Pulmonary hyperinflation

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Comparative efficacy and tolerability of beclomethasone/formoterol and fluticasone/salmeterol fixed combination in Taiwanese asthmatic patients. / Hsieh, Meng Jer; Lin, Yu Ching; Lai, Ruay Sheng; Wu, Chien Liang; Lai, Chun Liang; Wang, Chin Chou; Perng, Diahn Warng; Kao, Shang Jyh; Chang, En Ting; Wang, Hao Chien; Perng, Wann Cherng; Hsu, Jeng Yuan; Lin, Ching Hsiung; Tsai, Ying Huang.

In: Journal of the Formosan Medical Association, 01.01.2017.

Research output: Contribution to journalArticle

Hsieh, Meng Jer ; Lin, Yu Ching ; Lai, Ruay Sheng ; Wu, Chien Liang ; Lai, Chun Liang ; Wang, Chin Chou ; Perng, Diahn Warng ; Kao, Shang Jyh ; Chang, En Ting ; Wang, Hao Chien ; Perng, Wann Cherng ; Hsu, Jeng Yuan ; Lin, Ching Hsiung ; Tsai, Ying Huang. / Comparative efficacy and tolerability of beclomethasone/formoterol and fluticasone/salmeterol fixed combination in Taiwanese asthmatic patients. In: Journal of the Formosan Medical Association. 2017.
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AU - Hsieh, Meng Jer

AU - Lin, Yu Ching

AU - Lai, Ruay Sheng

AU - Wu, Chien Liang

AU - Lai, Chun Liang

AU - Wang, Chin Chou

AU - Perng, Diahn Warng

AU - Kao, Shang Jyh

AU - Chang, En Ting

AU - Wang, Hao Chien

AU - Perng, Wann Cherng

AU - Hsu, Jeng Yuan

AU - Lin, Ching Hsiung

AU - Tsai, Ying Huang

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N2 - 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. Conclusions: 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.

AB - 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. Conclusions: 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.

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