Difference in time-course of improvement in asthma control measures between budesonide and budesonide/formoterol

Pulm Pharmacol Ther. 2013 Apr;26(2):189-94. doi: 10.1016/j.pupt.2012.10.006. Epub 2012 Oct 30.


Combinations of inhaled corticosteroids (ICS) and inhaled long-acting beta(2)-agonists (LABA) have become widely used for the initiation of maintenance treatment for asthma. However, it has not been fully elucidated whether ICS/LABA alters the time-course of different control outcome measures in steroid-naive patients with asthma compared to the treatment with ICS alone. We compared the time-response in Asthma Control Questionnaire (ACQ), forced expiratory volume in 1 s (FEV1), exhaled nitric oxide fraction (FE(NO)), and airway responsiveness to methacholine (PD(200)) between budesonide (BUD) and budesonide/formoterol (BUD/FM). BUD/FM therapy significantly improved the ACQ score at week 2 and week 4 (p < 0.01 and p < 0.05), and increased FEV1 and the methacholine threshold at week 8 and week 24 (all p < 0.05) compared to BUD alone. A logistic function model showed that the BUD/FM combination significantly improved ACQ, FEV1, FE(NO) and PD(200) at a faster rate than BUD over 24 weeks (p < 0.001 for ACQ, FEV1, PD(200), and p < 0.05 for FE(NO), z-test). A significant variance in the time-response was also found in the outcomes of the two treatment groups (FE(NO) and ACQ > FEV1 and PD(200), p < 0.001, z-test). The present study provides evidence that ICS/LABA combination therapy results in a more rapid improvement in asthma symptoms, lung function, and airway inflammation compared to ICS monotherapy in steroid-naive patients with asthma.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adrenal Cortex Hormones / administration & dosage
  • Adrenergic beta-2 Receptor Agonists / administration & dosage
  • Adult
  • Asthma / drug therapy*
  • Asthma / physiopathology
  • Breath Tests
  • Bronchodilator Agents / therapeutic use*
  • Budesonide / administration & dosage
  • Budesonide / adverse effects
  • Budesonide / therapeutic use*
  • Ethanolamines / administration & dosage*
  • Ethanolamines / adverse effects
  • Female
  • Forced Expiratory Volume / drug effects
  • Formoterol Fumarate
  • Humans
  • Male
  • Nitric Oxide / analysis
  • Prospective Studies


  • Adrenal Cortex Hormones
  • Adrenergic beta-2 Receptor Agonists
  • Bronchodilator Agents
  • Ethanolamines
  • Nitric Oxide
  • Budesonide
  • Formoterol Fumarate