Step-down treatment from medium-dosage of budesonide/formoterol in controlled asthma

Respir Med. 2016 Oct;119:1-6. doi: 10.1016/j.rmed.2016.08.007. Epub 2016 Aug 15.


Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Clinical trial registration: This study was registered to UMIN-CTR (, UMIN000010333.

Keywords: Asthma; Inhaled corticosteroid; Long acting beta agonists; Pulmonary function; Step-down.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Inhalation
  • Adrenal Cortex Hormones / therapeutic use
  • Adrenergic beta-2 Receptor Agonists / therapeutic use
  • Adult
  • Aged
  • Anti-Asthmatic Agents / therapeutic use
  • Asthma / drug therapy*
  • Asthma / epidemiology
  • Asthma / physiopathology
  • Budesonide / administration & dosage
  • Budesonide / pharmacology*
  • Disease Progression
  • Drug Therapy, Combination / adverse effects
  • Drug Therapy, Combination / methods
  • Female
  • Forced Expiratory Volume / drug effects
  • Formoterol Fumarate / administration & dosage
  • Formoterol Fumarate / pharmacology*
  • Humans
  • Incidence
  • Male
  • Middle Aged
  • Nitric Oxide / metabolism
  • Outcome Assessment, Health Care
  • Prospective Studies
  • Respiratory Function Tests / methods


  • Adrenal Cortex Hormones
  • Adrenergic beta-2 Receptor Agonists
  • Anti-Asthmatic Agents
  • Nitric Oxide
  • Budesonide
  • Formoterol Fumarate