The effect of adjustable dosing with budesonide/formoterol on health-related quality of life and asthma control compared with fixed dosing

Curr Med Res Opin. 2004 Aug;20(8):1209-20. doi: 10.1185/030079903125004303.


Background: Budesonide/formoterol in a single inhaler is an effective therapy for asthma. We investigated whether adjustable maintenance dosing with budesonide/formoterol could maintain health-related quality of life (HRQL) and asthma control.

Patients/methods: Asthma patients (n = 4025) received budesonide/formoterol (Symbicort 160/4.5 microg) 2 inhalations twice daily (b.i.d.) for 4 weeks during run-in of this open, multicentre study. Patients were randomised to adjustable dosing (budesonide/formoterol 1 inhalation b.i.d.; stepping up to 2 or 4 inhalations bid for 1 week if asthma worsened) or fixed dosing (budesonide/formoterol 2 inhalations b.i.d.), for 12 weeks. Change in HRQL (standardised Asthma Quality of Life Questionnaire, AQLQ[S], score) during randomised treatment was the primary efficacy variable. Secondary variables included asthma control (peak expiratory flow [PEF], symptom-severity score, nocturnal awakenings, reliever-medication use) and study-medication intake.

Results: Clinically significant (> or = 0.5) improvements in AQLQ(S) score (mean 0.73), morning and evening PEF (mean 42.5 and 24.8 L/min, respectively), and symptom-severity score (mean 0.36) were achieved during run-in. The improvements were maintained in both groups although, overall, adjustable-dosing patients took fewer daily inhalations of budesonide/formoterol than fixed-dosing patients (mean 2.63 versus 3.82, p < 0.001).

Conclusion: Adjustable maintenance dosing with budesonide/formoterol maintains HRQL and asthma control as effectively as fixed dosing and is associated with a reduced drug load overall.

Publication types

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

MeSH terms

  • Administration, Inhalation
  • Adolescent
  • Adult
  • Aged
  • Anti-Asthmatic Agents / administration & dosage*
  • Asthma / diagnosis
  • Asthma / drug therapy*
  • Budesonide / administration & dosage*
  • Drug Administration Schedule
  • Drug Combinations
  • Ethanolamines / administration & dosage*
  • Female
  • Formoterol Fumarate
  • Humans
  • Male
  • Metered Dose Inhalers
  • Middle Aged
  • Quality of Life
  • Respiratory Function Tests
  • Treatment Outcome


  • Anti-Asthmatic Agents
  • Drug Combinations
  • Ethanolamines
  • Budesonide
  • Formoterol Fumarate