Beclomethasone/formoterol vs fluticasone/salmeterol inhaled combination in moderate to severe asthma

Allergy. 2007 Oct;62(10):1182-8. doi: 10.1111/j.1398-9995.2007.01493.x.


Background: Recommended treatment for moderate to severe asthma is the combination of an inhaled corticosteroid and a long-acting beta(2)-agonist. The present study was designed to compare a new fixed combination of extrafine beclomethasone and formoterol, with the fixed combination fluticasone and salmeterol.

Methods: This was a phase III, multinational, multicentre, double-blind, randomized, two-arm parallel groups, controlled study. After a 2-week run-in period, 228 patients with moderate to severe asthma were randomized to a 12-week treatment with either beclomethasone 100 microg plus formoterol 6 microg or fluticasone 125 microg plus salmeterol 25 microg, both delivered two inhalations b.i.d. via a pressurized metered dose inhaler.

Results: The analysis of noninferiority on the primary outcome, morning peak expiratory flow in the last 2 weeks of treatment, showed no difference between groups (difference -3.32 l/min; 95% CI -17.92 to 11.28). A significant improvement from baseline in lung function, symptom score and rescue medication use was observed in both groups at all time points. Beclomethasone plus formoterol combination showed a significantly faster onset of bronchodilation when compared with fluticasone plus salmeterol with the difference maintained for up to 1 h postdosing. No differences were observed between treatments in the rate of asthma exacerbations, frequency of adverse events and overnight urinary cortisol/creatinine ratio.

Conclusions: The new combination of extrafine beclomethasone plus formoterol is not inferior to the marketed combination of fluticasone and salmeterol in terms of efficacy and tolerability, with the advantage of a faster onset of bronchodilation. ( number, NCT00394368).

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Albuterol / administration & dosage
  • Albuterol / analogs & derivatives*
  • Androstadienes / administration & dosage*
  • Anti-Asthmatic Agents / administration & dosage*
  • Asthma / drug therapy*
  • Beclomethasone / administration & dosage*
  • Bronchodilator Agents / administration & dosage*
  • Drug Combinations
  • Ethanolamines / administration & dosage*
  • Female
  • Fluticasone
  • Formoterol Fumarate
  • Humans
  • Male
  • Metered Dose Inhalers
  • Middle Aged
  • Peak Expiratory Flow Rate
  • Salmeterol Xinafoate
  • Severity of Illness Index
  • Time Factors


  • Androstadienes
  • Anti-Asthmatic Agents
  • Bronchodilator Agents
  • Drug Combinations
  • Ethanolamines
  • Salmeterol Xinafoate
  • Fluticasone
  • Beclomethasone
  • Albuterol
  • Formoterol Fumarate

Associated data