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

  • Original Research Article
  • Published:
American Journal of Respiratory Medicine

Abstract

Background

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.

Methods

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.

Results

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.

Conclusion

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.

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Acknowledgements

This study was sponsored by AstraZeneca, Lund, Sweden. Eric D. Bateman has received honoraria for consultancy activities and lectures from AstraZeneca, GSK, Boehringer Ingelheim, Kyowa Hakko and Pfizer. Rudolf M. Huber has received reimbursement for attending international conferences, and fees for speaking over the last 5 years from GSK, AstraZeneca and Altana. Ian Naya is a full-time employee of AstraZeneca. Theo A. Bantje, Maria Joao Gomes, Michael G. Toumbis and Avraham Eliraz have no competing interest.

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Authors and Affiliations

  1. University of Cape Town, Cape Town, South Africa

    Eric D. Bateman

  2. Interconfessional Hospital de Baronie, Langendijk, Breda, The Netherlands

    Theo A. Bantje

  3. Hospital De Pulido Valente, Alameda das Linhas de Torres, Lisbon, Portugal

    Maria João Gomes

  4. 6th Department of Pulmonology, Sotiria Hospital, Athens, Greece

    Michael G. Toumbis

  5. Medizinische Klinik Innenstadt, Ludwig-Maximilians University, Munich, Germany

    Rudolf M. Huber

  6. AstraZeneca, Alderley Park, Macclesfield, Cheshire, UK

    Ian Naya

  7. Pulmonary Department, Kaplan Hospital, Il-Rehovot, Israel

    Avraham Eliraz

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  1. Eric D. Bateman
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  2. Theo A. Bantje
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  3. Maria João Gomes
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  4. Michael G. Toumbis
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  7. Avraham Eliraz
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Correspondence to Eric D. Bateman.

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Bateman, E.D., Bantje, T.A., Gomes, M.J. et al. Combination Therapy with Single Inhaler Budesonide/Formoterol Compared with High Dose of Fluticasone Propionate Alone in Patients with Moderate Persistent Asthma. Am J Respir Med 2, 275–281 (2003). https://doi.org/10.1007/BF03256655

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