title: A comparison of long-term anti-inflammatory effect of two ICS/LABA combination inhalers; fix-dosed maintenance therapy with budesonide/formoterol and salmeterol/fluticasone.
abstract: 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.
authors.affiliation: Division of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan; Department of Respiratory Medicine, Juntendo University School of Medicine, Tokyo, Japan.
authors.forename: Masayuki
authors.initials: M
authors.lastname: Hojo
authors.affiliation: Division of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan.
authors.forename: Motoyasu
authors.initials: M
authors.lastname: Iikura
authors.affiliation: Division of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan.
authors.forename: Junko
authors.initials: J
authors.lastname: Hirashima
authors.affiliation: Division of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan.
authors.forename: Manabu
authors.initials: M
authors.lastname: Suzuki
authors.affiliation: Division of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan.
authors.forename: Haruhito
authors.initials: H
authors.lastname: Sugiyama
mesh_terms: D000305:Adrenal Cortex Hormones / Q000008:administration & dosage* / Q000009:adverse effects; D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000008:administration & dosage / Q000031:analogs & derivatives; D000730:Androstadienes / Q000008:administration & dosage; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D019819:Budesonide / Q000008:administration & dosage; D016022:Case-Control Studies; D004338:Drug Combinations; D004983:Ethanolamines / Q000008:administration & dosage; D045853:Exhalation; D005260:Female; D000068297:Fluticasone-Salmeterol Drug Combination; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D009569:Nitric Oxide; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D058666:Adrenergic beta-2 Receptor Agonists; D000730:Androstadienes; D004338:Drug Combinations; D004983:Ethanolamines; D000068297:Fluticasone-Salmeterol Drug Combination; D009569:Nitric Oxide; D019819:Budesonide; D000420:Albuterol; D000068759:Formoterol Fumarate