title: Effects of beclomethason/formoterol and budesonide/formoterol fixed combinations on lung function and airway inflammation in patients with mild to moderate asthma--an exploratory study.
abstract: BACKGROUND
  Asthma is a chronic inflammatory airway disease of the whole bronchial tree. In this exploratory study we investigated the effects of beclomethasone/formoterol (becl/form) and budesonide/formoterol (bud/form) fixed combinations on lung function and airway inflammation in patients with mild to moderate asthma.
  
  
  METHODS
  22 adult patients with asthma (mean FEV1 91.6% pred.) were recruited to this prospective phase IV, double-blind, double-dummy, two-way cross-over, single-centre, randomised study. After a 7 days run-in period with bud 200 μg bid patients were randomised to receive 4 weeks of becl/form (100/6 μg) bid in a pressurised metered dose inhaler or bud/form (160/4.5 μg) bid administered via dry powder inhaler. We measured spirometry, bodyplethysmography, impulse oscillometry, nitric oxide (NO) and its alveolar fraction (CAlv), and assessed sputum cellularity.
  
  
  RESULTS
  CAlv significantly decreased after 4 weeks of treatment in each treatment period. The adjusted geometric mean (log transformed data, end of treatment vs. baseline) was 0.942 ppb (95% CI: 0.778-1.141 ppb) for becl/form and 0.903 ppb (95% CI: 0.741-1.099 ppb) for bud/form. Impulse oscillometry revealed a significant decrease in mean Delta R5-R20 of -0.033 kPa * L(-1) * sec(-1) for becl/form (95% CI: -0.064 to -0.002) and of -0.048 033 kPa * L(-1) * sec(-1) for bud/form (95% CI: -0.079 to -0.017). Other parameters of lung function and NO showed numerically small and in most cases statistically non-significant changes.
  
  
  CONCLUSIONS
  In patients with mild to moderate asthma pre-treated with inhaled corticosteroids, the use of ICS/LABA formulations led to improvements of CAlv and Delta R5-R20 indicating that these parameters might be helpful to further assess the effects of inhaled ICS/LABA combinations on lung function and airway inflammation.
authors.affiliation: Pulmonary Research Institute at LungClinic Grosshansdorf, Airway Research Center North, Member of the German Center for Lung Research, Grosshansdorf, Germany. Electronic address: a.kirsten@pulmoresearch.de.
authors.forename: Anne-Marie
authors.initials: AM
authors.lastname: Kirsten
authors.affiliation: Pulmonary Research Institute at LungClinic Grosshansdorf, Airway Research Center North, Member of the German Center for Lung Research, Grosshansdorf, Germany.
authors.forename: Henrik
authors.initials: H
authors.lastname: Watz
authors.affiliation: Chiesi Farmaceutici S.p.A., Parma, Italy.
authors.forename: Caterina
authors.initials: C
authors.lastname: Brindicci
authors.affiliation: Chiesi Farmaceutici S.p.A., Parma, Italy.
authors.forename: Annalisa
authors.initials: A
authors.lastname: Piccinno
authors.affiliation: Pulmonary Research Institute at LungClinic Grosshansdorf, Airway Research Center North, Member of the German Center for Lung Research, Grosshansdorf, Germany.
authors.forename: Helgo
authors.initials: H
authors.lastname: Magnussen
mesh_terms: D000280:Administration, Inhalation; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D001507:Beclomethasone / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D000069502:Budesonide, Formoterol Fumarate Drug Combination / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D000068759:Formoterol Fumarate / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D007249:Inflammation / Q000188:drug therapy; D008297:Male; D010349:Patient Compliance; D011446:Prospective Studies; D012129:Respiratory Function Tests; D012720:Severity of Illness Index; D013183:Sputum / Q000276:immunology
chemical_list: D018927:Anti-Asthmatic Agents; D000069502:Budesonide, Formoterol Fumarate Drug Combination; D004338:Drug Combinations; D001507:Beclomethasone; D000068759:Formoterol Fumarate
keywords: Bodyplethysmography; Controlled asthma; Impulse oscillometry; Inhaled corticosteroids/long-acting beta-2-agonists fixed combination; Nitric oxide measurements; Spirometry