A comparison of long-term anti-inflammatory effect of two ICS/LABA combination inhalers; fix-dosed maintenance therapy with budesonide/formoterol and salmeterol/fluticasone

Allergol Int. 2014 Mar;63(1):103-11. doi: 10.2332/allergolint.13-OA-0590.


Background: The clinical usefulness of fixed-dose maintenance therapy with salmeterol/fluticasone (SFC) and budesonide/formoterol combination inhaler (BUD/FM) has been established, though evidence of the long-term anti-inflammatory effects of these 2 inhalers are limited.

Methods: Patients with moderate persistent adult asthma who had received SFC 50/250μg bid with well-control status were recruited. After switching to 8-week therapy with fixed-dose BUD/FM 4 puffs (640/18μg) (phase-1), patients chose either SFC or BUD/FM. FeNO and ACT score were evaluated every 8 weeks until the end of the 52-week treatment period for both treatment groups (phase-2).

Results: In total, 103 patients were examined: BUD/FM was chosen by 34 patients (BUD/FM group), while SFC was chosen by 23 (SFC group). Thirty-six received SFC consistently from the beginning of the study (control). Patients in the BUD/FM and SFC groups showed significant improvements in ACT scores and FeNO levels in phase-1; these beneficial effects persisted for 52 weeks in the BUD/FM group. On the other hand, in the SFC group, although the FeNO level decreased from 54.3 ± 26.4 ppb to 41.9 ± 18.3 ppb in phase-1, it increased to 54.5 ± 26.2 ppb, a level similar to the baseline prior to the beginning of BUD/FM therapy, at 8 weeks in phase-2, and remained at 50-odd ppb thereafter.

Conclusions: These results suggest that maintenance therapy with fixed-dose BUD/FM is a useful treatment option exerting an airway anti-inflammatory effect for a period as long as 1 year, even for asthmatics who could not accomplish total control with SFC.

Publication types

  • Comparative Study

MeSH terms

  • Adrenal Cortex Hormones / administration & dosage*
  • Adrenal Cortex Hormones / adverse effects
  • Adrenergic beta-2 Receptor Agonists / administration & dosage*
  • Adrenergic beta-2 Receptor Agonists / adverse effects
  • Adult
  • Aged
  • Albuterol / administration & dosage
  • Albuterol / analogs & derivatives
  • Androstadienes / administration & dosage
  • Asthma / drug therapy*
  • Asthma / physiopathology
  • Budesonide / administration & dosage
  • Case-Control Studies
  • Drug Combinations
  • Ethanolamines / administration & dosage
  • Exhalation
  • Female
  • Fluticasone-Salmeterol Drug Combination
  • Formoterol Fumarate
  • Humans
  • Male
  • Medication Adherence
  • Middle Aged
  • Nebulizers and Vaporizers
  • Nitric Oxide
  • Young Adult


  • Adrenal Cortex Hormones
  • Adrenergic beta-2 Receptor Agonists
  • Androstadienes
  • Drug Combinations
  • Ethanolamines
  • Fluticasone-Salmeterol Drug Combination
  • Nitric Oxide
  • Budesonide
  • Albuterol
  • Formoterol Fumarate