Allergol Int. 2012 Jun;61(2):323-9.

Effect of Switching from Salmeterol/Fluticasone to Formoterol/Budesonide Combinations in Patients with Uncontrolled Asthma

Taisuke Akamatsu1, Toshihiro Shirai2, Masato Kato1, Dai Hashimoto1, Hideki Yasui1, Naoki Inui1, Takafumi Suda1, Koshi Yokomura3, Hiroshi Hayakawa4, Kyotaro Ide5, Mikio Toyoshima6, Shigeki Kuroishi7, Kazumasa Yasuda8, Hideki Suganuma9, Takashi Yamada10, 
Masafumi Masuda11, Kingo Chida1

1Department of Respiratory Medicine, Hamamatsu University School of Medicine, 2Department of Respiratory Medicine, Shizuoka General Hospital, 3Department of Pulmonary Medicine, Seirei Mikatahara General Hospital, 4Department of Respiratory Medicine, Tenryu Hospital, National Hospital Organization, 5Department of Respiratory Medicine, Japanese Red Cross Hamamatsu Hospital, 6Department of Respiratory Medicine, Hamamatsu Rosai Hospital, 7Department of Respiratory Medicine, Enshu Hospital, 8Department of Respiratory Medicine, Iwata City Hospital, 9Department of Respiratory Medicine, Shimada Municipal Hospital, 10Department of Respiratory Medicine, Shizuoka City Shizuoka Hospital and 11Department of Respiratory Medicine, Shizuoka City Shimizu Hospital, Shizuoka, Japan.

 

Abstract

Background: Combination therapy with an inhaled corticosteroid (ICS) and a long-acting β2-agonist (LABA) in a single inhaler is the mainstay of asthma management and salmeterol/fluticasone combination (SFC) and fixed-dose formoterol/budesonide combination (FBC) are currently available in Japan; however, there is nothing to choose between the two. The purpose of this study was to clarify the effect of switching from SFC to FBC in patients with asthma not adequately controlled under the former treatment regimen.

Methods: This was a prospective, multicenter, open-label, uncontrolled longitudinal study in 87 adult patients with an Asthma Control Questionnaire, 5-item version (ACQ5) score of greater than 0.75 under treatment with SFC 50/250 μg one inhalation twice daily (bid). SFC was switched to FBC 4.5/160 μg two inhalations bid. Study outcomes included ACQ5 score, peak expiratory flow (PEF), FEV1, and fractional exhaled nitric oxide (FeNO) at the end of treatment period.

Results: Eighty-three patients completed the study. ACQ5 scores improved and exceeded the clinically meaningful difference after 12 weeks of treatment and well-controlled asthma (ACQ5 score≦0.75) was attained in 37 (44.6%) patients. Minimum and maximum PEF and FEV1 values improved significantly (figures 1 and 2), but not FeNO values, after switching from SFC to FBC.

Conclusions: Switching ICS/LABA combination therapy is a useful option in the management of asthma that is not optimally controlled.

 

Highlight:

  • SFC 50/250 one inhalation bid was switched to FBC 4.5/160 μg two inhalations bid in 87 adult patients with asthma not adequately controlled under the former treatment regimen.
  • Well-controlled asthma was attained in about half of the patients and ACQ5 score, PEF and FEV1 values improved significantly after switching.
  • Switching ICS/LABA combination therapy is an important option in the management of asthma.

Supplemental figures:

Figure1

Figure 1. Changes in ACQ5 score. The line across the box is the median, the top and bottom portions of the box represent the 25th and 75th percentiles, respectively, and the whiskers indicate the maximum and minimum values at week 0 and 12. *p < 0.0001.

 figure2Figure 2. Changes in FEV1. The line across the box is the median, the top and bottom portions of the box represent the 25th and 75th percentiles, respectively, and the whiskers indicate the maximum and minimum values at week 0 and 12. *p < 0.05.

 

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