Step-down treatment from medium-dosage of budesonide/formoterol in controlled asthma.
The stepping down of asthma treatment can be considered when asthma symptoms have been well controlled with inhaled corticosteroids (ICSs)/long-acting β2 adrenergic agonists (LABAs). However, few data are available comparing the efficacy between two step-down strategies, to reduce ICS/LABA dose or to withdraw LABA continuing ICS, in well-controlled asthmatics.



This was a prospective multicentre randomized, two-arm, controlled study. Ninety-one asthmatic patients controlled by budesonide/formoterol combination (BFC) 320/9 μg twice daily were assigned to 2 stepping-down treatments as follows: the BFC group; BUD/FM 160/4.5 μg twice daily, and the ICS group; ICS (budesonide 400 μg twice daily or equivalent dose of ICS) without LABA, and followed for 12 weeks. The primary outcome was the incidence of asthma exacerbations. Asthma control, pulmonary function tests, and fraction of exhaled nitric oxide (FeNO) were evaluated at the beginning and end of the period.



The incidence of exacerbations was 16.3% in the BFC groups and 12.5% in the ICS group, which were not different between the groups (p = 0.766). No significant differences were found in QOL score and FeNO between 0 week and 12 week in the both group. FEV1 and FEV1 percentage of the predicted value were lower at week 12 than at week 0 in the ICS group, but not in the BFC group.



The two step-down strategies for 12 weeks have equal acceptability in well-controlled asthmatics treated with medium-dose of BFC, however, withdrawal of LABA may have potential risk to deteriorate FEV1.



This study was registered to UMIN-CTR (http://www.umin.ac.jp/ctr/), UMIN000010333.
Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan.
Kazutaka
K
Mori
Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan. Electronic address: fujisawa@hama-med.ac.jp.
Tomoyuki
T
Fujisawa
Department of Clinical Pharmacology and Therapeutics, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan.
Naoki
N
Inui
Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan.
Dai
D
Hashimoto
Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan.
Noriyuki
N
Enomoto
Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan.
Yutaro
Y
Nakamura
Department of Respiratory Medicine, Ensyu Hospital, 1-1-1 Chuou, Naka-ku, Hamamatsu, 430-0929, Japan.
Shigeki
S
Kuroishi
Department of Respiratory Medicine, Seirei Mikatahara General Hospital, 3453 Mikatahara-cho, Kita-ku, Hamamatsu, 433-8558, Japan.
Koshi
K
Yokomura
Department of Respiratory Medicine, Hamamatsu Rosai Hospital, 25 Shougen-cho, Higashi-ku, Hamamatsu, 430-8525, Japan.
Mikio
M
Toyoshima
Department of Respiratory Medicine, Iwata City Hospital, 513-2 Ohkubo, Iwata, 438-8550, Japan.
Shiro
S
Imokawa
Department of Respiratory Medicine, Shizuoka City Shizuoka Hospital, 10-93 Ote-cho, Aoi-ku, Shizuoka, 420-8630, Japan.
Takashi
T
Yamada
Department of Respiratory Medicine, Shizuoka General Hospital, 4-27-1 Kita-ando, Aoi-ku, Shizuoka, 420-0881, Japan.
Toshihiro
T
Shirai
Department of Respiratory Medicine, Shizuoka City Shimizu Hospital, 1231 Miyakami, Shimizu-ku, Shizuoka, 424-8636, Japan.
Masafumi
M
Masuda
Department of Respiratory Medicine, Tenryu Hospital, National Hospital Organization, 4201-2 Oro, Hamakita-ku, Hamamatsu, 434-8511, Japan.
Hiroshi
H
Hayakawa
Department of Internal Medicine, Hamamatsu Toyooka Hospital, 110 Toyooksa-cho, Kita-ku, Hamamatsu, 433-8103, Japan.
Kingo
K
Chida
Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan.
Takafumi
T
Suda
D000280:Administration, Inhalation; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D058666:Adrenergic beta-2 Receptor Agonists / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D019819:Budesonide / Q000008:administration & dosage / Q000494:pharmacology*; D018450:Disease Progression; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000379:methods; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D000068759:Formoterol Fumarate / Q000008:administration & dosage / Q000494:pharmacology*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009569:Nitric Oxide / Q000378:metabolism; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D012129:Respiratory Function Tests / Q000379:methods
D000305:Adrenal Cortex Hormones; D058666:Adrenergic beta-2 Receptor Agonists; D018927:Anti-Asthmatic Agents; D009569:Nitric Oxide; D019819:Budesonide; D000068759:Formoterol Fumarate
Asthma; Inhaled corticosteroid; Long acting beta agonists; Pulmonary function; Step-down