Efficacy and safety of fluticasone/formoterol combination therapy in patients with moderate-to-severe asthma

Respir Med. 2013 Feb;107(2):180-95. doi: 10.1016/j.rmed.2012.10.025. Epub 2012 Dec 25.


Background: The inhaled corticosteroid, fluticasone propionate, and the long-acting β(2)-adrenergic agonist, formoterol fumarate, are both highly effective treatments for bronchial asthma. This study (NCT00393952/EudraCT number: 2006-005989-39) compared the efficacy and safety of fluticasone/formoterol combination therapy (flutiform(®); 250/10 μg) administered twice daily (b.i.d.) via a single aerosol inhaler, with the individual components (fluticasone 250 μg b.i.d.; formoterol 10 μg b.i.d.), in adult and adolescent patients with moderate-to-severe asthma.

Methods: This was a 12-week, double-blind, randomised, parallel-group, multicentre, placebocontrolled phase 3 study. The co-primary efficacy endpoints were: i) the mean change in the forced expiratory volume in the first second (FEV(1)) from morning pre-dose at baseline to pre-dose at week 12 (fluticasone/formoterol 250/10 μg vs. formoterol), ii) the mean change in FEV(1) from morning pre-dose at baseline to 2 h post-dose at week 12 (fluticasone/formoterol 250/10 μg vs. fluticasone), and iii) the number of patients who discontinued prematurely due to lack of treatment efficacy (fluticasone/formoterol 250/10 μg vs. placebo). The secondary endpoints included measures of lung function, disease control, and asthma symptoms. Safety was assessed based on adverse events, vital signs, and clinical laboratory evaluations.

Results: Overall, 395 (70.9%) patients completed the study. Fluticasone/formoterol 250/10 μg b.i.d. was superior to the individual components and placebo for all three co-primary endpoints and demonstrated numerically greater improvements for multiple secondary efficacy analyses. Fluticasone/formoterol combination therapy had a good safety profile over the 12 weeks.

Conclusion: Fluticasone/formoterol combination therapy will provide clinicians with an efficacious alternative treatment option for patients with moderate-to-severe asthma.

Publication types

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

MeSH terms

  • Administration, Inhalation
  • Adolescent
  • Adrenergic beta-2 Receptor Agonists / administration & dosage*
  • Adrenergic beta-2 Receptor Agonists / adverse effects
  • Adrenergic beta-2 Receptor Agonists / therapeutic use
  • Adult
  • Aged
  • Aged, 80 and over
  • Androstadienes / administration & dosage*
  • Androstadienes / adverse effects
  • Androstadienes / therapeutic use
  • Asthma / drug therapy*
  • Asthma / physiopathology
  • Bronchodilator Agents / administration & dosage*
  • Bronchodilator Agents / adverse effects
  • Bronchodilator Agents / therapeutic use
  • Double-Blind Method
  • Drug Administration Schedule
  • Drug Combinations
  • Ethanolamines / administration & dosage*
  • Ethanolamines / adverse effects
  • Ethanolamines / therapeutic use
  • Female
  • Fluticasone
  • Forced Expiratory Volume / drug effects
  • Formoterol Fumarate
  • Humans
  • Male
  • Metered Dose Inhalers
  • Middle Aged
  • Treatment Failure
  • Treatment Outcome
  • Young Adult


  • Adrenergic beta-2 Receptor Agonists
  • Androstadienes
  • Bronchodilator Agents
  • Drug Combinations
  • Ethanolamines
  • Fluticasone
  • Formoterol Fumarate