American Journal of Respiratory Medicine

, Volume 2, Issue 3, pp 275–281

Combination Therapy with Single Inhaler Budesonide/Formoterol Compared with High Dose of Fluticasone Propionate Alone in Patients with Moderate Persistent Asthma

  • Eric D. Bateman
  • Theo A. Bantje
  • Maria João Gomes
  • Michael G. Toumbis
  • Rudolf M. Huber
  • Ian Naya
  • Avraham Eliraz
Original Research Article

DOI: 10.1007/BF03256655

Cite this article as:
Bateman, E.D., Bantje, T.A., Gomes, M.J. et al. Am J Respir Med (2003) 2: 275. doi:10.1007/BF03256655



The efficacy and safety of Symbicort®1 (budesonide and formoterol in a single inhaler) were compared with those of a high dose of the commonly used corticosteroid fluticasone propionate in patients with moderate persistent asthma.


This randomized, double-blind, double-dummy, parallel-group study involved 373 patients with asthma (mean age 42 years; FEV1 78% of predicted; reversibility 21%). After a 2-week run-in period, during which patients received budesonide 200μg twice daily, they were randomly assigned to treatment with either Symbicort® Turbuhaler® (budesonide/formoterol 160/4.5μg, one inhalation twice daily) or Flovent®/Flixotide® Diskus™ (fluticasone propionate 250μg twice daily) for 12 weeks.


Significantly greater increases in morning PEF, the primary efficacy variable, were observed in patients treated with budesonide/formoterol compared with fluticasone propionate (27.4 L/min vs 7.7 L/min; p < 0.001). Evening PEF and clinic FEV1 also favored budesonide/formoterol compared with fluticasone propionate (p < 0.001), as did use of reliever medication (p = 0.04) and the proportion of reliever-free days (p < 0.001). There were also numerical improvements in symptom-free days (60.4% vs 55.5%), night-time awakenings (7.9% vs 9.6%) and asthma-control days (57.8% vs 52.4%) in favor of budesonide/formoterol. The risk of an exacerbation was reduced by 32% in the budesonide/formoterol group compared with the fluticasone propionate group (p < 0.05). Both treatments were well tolerated.


Symbicort® (budesonide/formoterol in a single inhaler) was more effective than a high dose of fluticasone propionate in improving lung function, reducing use of reliever medication and improving control of moderate persistent asthma.

Copyright information

© Adis Data Information BV 2003

Authors and Affiliations

  • Eric D. Bateman
    • 1
  • Theo A. Bantje
    • 2
  • Maria João Gomes
    • 3
  • Michael G. Toumbis
    • 4
  • Rudolf M. Huber
    • 5
  • Ian Naya
    • 6
  • Avraham Eliraz
    • 7
  1. 1.University of Cape TownCape TownSouth Africa
  2. 2.Interconfessional Hospital de BaronieLangendijk, BredaThe Netherlands
  3. 3.Hospital De Pulido ValenteLisbonPortugal
  4. 4.6th Department of PulmonologySotiria HospitalAthensGreece
  5. 5.Medizinische Klinik InnenstadtLudwig-Maximilians UniversityMunichGermany
  6. 6.AstraZenecaMacclesfield, CheshireUK
  7. 7.Pulmonary DepartmentKaplan HospitalIl-RehovotIsrael
  8. 8.UCT Lung InstituteMowbray, Cape TownSouth Africa