title: Clinical efficacy and safety of budesonide-formoterol in non-cystic fibrosis bronchiectasis.
abstract: BACKGROUND
  The aim of this study is to evaluate the efficacy and safety of medium-dose formoterol-budesonide combined inhaled treatment in a single inhaler compared with high-dose budesonide treatment in patients with non-cystic fibrosis (non-CF) bronchiectasis.
  
  
  METHODS
  This is a 12-month randomized, double-blind, parallel-groups clinical trial, to run in 40 patients with non-CF bronchiectasis diagnosed by high-resolution CT scan of the chest, receiving formoterol-budesonide combined treatment (18/640 μg daily) or budesonide treatment (1,600 μg daily). Variables concerning clinical condition, health-related quality of life (HRQL), lung function, β(2)-adrenergic agonist use, potentially pathogenic microorganism (PPM) isolates, and medication side effects were analyzed by intention-to-treat analysis.
  
  
  RESULTS
  The study group receiving a formoterol-budesonide combined treatment showed a significant improvement, both clinically and statistically, of symptoms (dyspnea, number of coughs, and rescue β(2)-adrenergic agonist-free days). Furthermore, we observed an HRQL improvement, with no changes in functional parameters or in PPM isolates, together with an important reduction in overall side effects, especially for those related to inhaled steroids, compared with the high-dose budesonide treatment group.
  
  
  CONCLUSIONS
  Inhaled medium-dose formoterol-budesonide combined treatment in a single inhaler is more effective and safe compared with high-dose budesonide treatment in patients with non-CF bronchiectasis.
  
  
  BACKGROUND
  ClinicalTrials.gov; No.: NCT00728715; URL: www.clinicaltrials.gov.
authors.affiliation: Pneumology Unit, La Fe University Hospital, Valencia, Spain; Pneumology Service, La Fe University Hospital, Valencia, Spain; CIBERes de enfermedades Respiratorias, Valencia, Spain. Electronic address: miangel@comv.es.
authors.forename: Miguel Ángel
authors.initials: MÁ
authors.lastname: Martínez-García
authors.affiliation: Pneumology Unit, La Fe University Hospital, Valencia, Spain.
authors.forename: Juan J
authors.initials: JJ
authors.lastname: Soler-Cataluña
authors.affiliation: Pneumology Unit, La Fe University Hospital, Valencia, Spain.
authors.forename: Pablo
authors.initials: P
authors.lastname: Catalán-Serra
authors.affiliation: Internal Medicine Service, General Hospital of Requena, La Fe University Hospital, Valencia, Spain.
authors.forename: Pilar
authors.initials: P
authors.lastname: Román-Sánchez
authors.affiliation: Pneumology Service, La Fe University Hospital, Valencia, Spain.
authors.forename: Miguel Perpiñá
authors.initials: MP
authors.lastname: Tordera
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000318:Adrenergic beta-Agonists / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001987:Bronchiectasis / Q000000981:diagnostic imaging / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D019819:Budesonide / Q000008:administration & dosage / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D004338:Drug Combinations; D004983:Ethanolamines / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012129:Respiratory Function Tests; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D000318:Adrenergic beta-Agonists; D001993:Bronchodilator Agents; D004338:Drug Combinations; D004983:Ethanolamines; D019819:Budesonide; D000068759:Formoterol Fumarate