title: Budesonide/formoterol maintenance and reliever therapy in asthma control: acute, dose-related effects and real-life effectiveness.
abstract: OBJECTIVE
  The efficacy of budesonide/formoterol maintenance and reliever therapy (BFMRT) in asthma control is well documented in large randomized controlled trials. However, the acute reliever effects and real-life effectiveness are seldom reported.
  
  
  METHODS
  This multicenter trial enrolled steroid-naïve, symptomatic asthmatics with baseline exhaled nitric oxide (eNO) of ≥ 40 ppb. There were 120 eligible patients who were randomized and received a dose of inhaled budesonide/formoterol 320/9 μg (lower dose budesonide/formoterol), 640/18 μg (higher dose budesonide/formoterol (HDBF)), or terbutaline (TERB) 1 mg. Inflammatory cells and mediators in induced sputum, eNO and lung function were measured at baseline and 6 h (acute phase). Subsequently, all patients used BFMRT as real-life practice for 24 weeks (maintenance phase).
  
  
  RESULTS
  In the acute phase, the degree of post-treatment reduction in total eosinophil counts, interleukin-8 and matrix metalloproteinase-9 in induced sputum were significantly greater in group HDBF (vs TERB, P < 0.05). The increase in forced expiratory volume in first second (FEV1 ) in group HDBF was significantly higher (vs LDBF and TERB, P < 0.05) 3 h after dosing. In the maintenance phase, significant improvement of asthma control (presented by eNO, FEV1 and a five-item asthma control questionnaire) in real-life settings was observed at 4 weeks and sustained to the end of study. The rate of patients who followed scheduled visits declined over time (87% at week 4 and 42% at week 24).
  
  
  CONCLUSIONS
  Budesonide/formoterol as reliever exerts acute, dose-related anti-inflammatory effects and FEV1 improvement in symptomatic asthmatics. BFMRT is effective in asthma control. However, the decrease in long-term follow-up rate remains an issue to overcome in real-life settings.
authors.affiliation: Division of Chest Medicine, Department of Internal Medicine, Changhua Christian Hospital, Changhua, Taiwan; Department of Respiratory Care, College of Health Sciences, Chang Jung Christian University, Tainan, Taiwan; School of Medicine, Chung Shan Medical University, Taichung, Taiwan.
authors.forename: Ching-Hsiung
authors.initials: CH
authors.lastname: Lin
authors.forename: Jeng-Yuan
authors.initials: JY
authors.lastname: Hsu
authors.forename: Yi-Han
authors.initials: YH
authors.lastname: Hsiao
authors.forename: Ching-Min
authors.initials: CM
authors.lastname: Tseng
authors.forename: Vincent Yi-Fong
authors.initials: VY
authors.lastname: Su
authors.forename: Yu-Hsuan
authors.initials: YH
authors.lastname: Chen
authors.forename: Sheau-Ning
authors.initials: SN
authors.lastname: Yang
authors.forename: Yu-Chin
authors.initials: YC
authors.lastname: Lee
authors.forename: Kang-Cheng
authors.initials: KC
authors.lastname: Su
authors.forename: Diahn-Warng
authors.initials: DW
authors.lastname: Perng
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001944:Breath Tests; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D000069502:Budesonide, Formoterol Fumarate Drug Combination / Q000008:administration & dosage*; D002452:Cell Count; D004338:Drug Combinations; D004804:Eosinophils; D004983:Ethanolamines / Q000627:therapeutic use; D045853:Exhalation; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D016209:Interleukin-8 / Q000032:analysis; D060046:Maintenance Chemotherapy; D008297:Male; D020780:Matrix Metalloproteinase 9 / Q000032:analysis; D008875:Middle Aged; D009569:Nitric Oxide / Q000032:analysis; D013183:Sputum / Q000737:chemistry / Q000166:cytology; D013726:Terbutaline / Q000627:therapeutic use; D014797:Vital Capacity; D055815:Young Adult
chemical_list: D001993:Bronchodilator Agents; D000069502:Budesonide, Formoterol Fumarate Drug Combination; C508606:CXCL8 protein, human; D004338:Drug Combinations; D004983:Ethanolamines; D016209:Interleukin-8; D009569:Nitric Oxide; D020780:Matrix Metalloproteinase 9; D013726:Terbutaline
keywords: acute anti-inflammation; eosinophil; exhaled nitric oxide; real-life effectiveness; reliever therapy