Budesonide/formoterol: a review of its use in asthma

Drugs. 2004;64(14):1597-618. doi: 10.2165/00003495-200464140-00006.


Budesonide and formoterol have been combined in a single dry powder device, Symbicort Turbuhaler (budesonide/formoterol 160/9-640/18 microg/day), in an effort to simplify asthma management. The efficacy of budesonide/formoterol as maintenance therapy in patients with asthma has been examined in several randomised studies.Twice-daily budesonide/formoterol was significantly more effective than an equivalent or higher daily dose of budesonide alone or high-dose fluticasone propionate alone at improving peak expiratory flow (PEF) in adults with predominantly moderate persistent asthma. Symptom control and the risk of mild exacerbations were significantly improved versus budesonide alone. Moreover, budesonide/formoterol appeared to be as effective as concurrent therapy with equivalent dosages of budesonide and formoterol administered via separate inhalers in adults with moderate persistent asthma. Budesonide/formoterol administered once daily was as effective as twice-daily administration (equivalent daily doses) and more effective than once-daily budesonide in adults with moderate persistent asthma. Twice-daily budesonide/formoterol significantly improved PEF compared with budesonide in paediatric patients with asthma. Adjustable maintenance dosing with budesonide/formoterol was associated with significantly less study drug use than fixed dosing with budesonide/formoterol in adults with predominantly mild or moderate persistent asthma. In two of three studies (all longer than 4 months' duration), the risk of exacerbations was significantly lower with adjustable than with fixed dosing, but no difference was detected in four short-term studies. Symptom severity was maintained or improved in most patients receiving either treatment regimen. In adults with moderate-to-severe persistent asthma, adjustable maintenance dosing with budesonide/formoterol reduced the rate of exacerbations and reliever medication use compared with fixed dosing with salmeterol/fluticasone propionate. Budesonide/formoterol was well tolerated in both fixed and adjustable dosing regimens. In conclusion, in patients with persistent asthma symptoms despite treatment with inhaled corticosteroids, budesonide/formoterol administered via a single dry powder Turbuhaler device is an effective, well tolerated, convenient treatment option, which may have the potential for improved compliance. It appears to be as effective as treatment with budesonide and formoterol administered via separate inhalers and is more effective than budesonide monotherapy in improving PEF, controlling symptoms and preventing mild exacerbations. Adjustable maintenance dosing with budesonide/formoterol is associated with a lower overall dosage and appears to maintain control as effectively as fixed dosing.

Publication types

  • Review

MeSH terms

  • Animals
  • Asthma / drug therapy*
  • Asthma / metabolism
  • Budesonide / pharmacokinetics
  • Budesonide / therapeutic use*
  • Clinical Trials as Topic / statistics & numerical data
  • Drug Combinations
  • Ethanolamines / pharmacokinetics
  • Ethanolamines / therapeutic use*
  • Formoterol Fumarate
  • Humans


  • Drug Combinations
  • Ethanolamines
  • Budesonide
  • Formoterol Fumarate