Combination Therapy with Single Inhaler Budesonide/Formoterol Compared with High Dose of Fluticasone Propionate Alone in Patients with Moderate Persistent Asthma
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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.
KeywordsAsthma Budesonide Fluticasone Propionate Formoterol Persistent Asthma
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.
- 1.National Institutes of Health: National Heart Lung and Blood Institute. Global Initiative for Asthma. Global strategy for asthma management and prevention. NHLBI/WHO Workshop Report. Report no. NIH-NHLI 95-3659. Bethesda (MD): National Institutes of Health National Heart and Lung Institute; 1995Google Scholar
- 2.National Institutes of Health: National Heart Lung and Blood Institute. National Asthma Education and Prevention Program. Expert panel report II: guidelines for the diagnosis and management of asthma. Report no. NIH-NHLI 97-4051. Bethesda (MD): National Institutes of Health National Heart and Lung Institute; 1997Google Scholar
- 3.National Institutes of Health: National Heart Lung and Blood Institute. Global Initiative for Asthma. Global strategy for asthma management and prevention. Report no. NIH-NHLI 02-3659. Bethesda (MD): National Institutes of Health National Heart and Lung Institute; 2002Google Scholar
- 9.Lalloo UG, Malolepszy J, Kozma D, et al. Symbicort® (budesonide and formoterol in a single inhaler) is more effective than increasing the dose of inhaled corticosteroids in mild asthma [abstract]. Am J Respir Crit Care Med 2001; 163: A863Google Scholar
- 11.O’Byrne PM, Barnes PJ, Rodriguez-Roison R, et al. Low dose inhaled budesonide with and without formoterol in steroid free patients with mild persistent asthma [abstract]. Am J Respir Crit Care Med 2001; 163: A862Google Scholar
- 15.Quanjer PH, Tammeling GJ, Cotes JE, et al. Lung volumes and forced ventilatory flows: report of the working party standardization of lung function tests, European Community for Steel and Coal: Official Statement of the European Respiratory Society. Eur Respir J 1993; 6 Suppl. 16: 5–40Google Scholar
- 16.National Institutes of Health: National Heart Lung and Blood Institute. Global initiative for asthma: Pocket Guide for asthma management and prevention. Report no. NIH-NHLI 96-3659B. Bethesda (MD): National Institutes of Health National Heart and Lung Institute; 1998Google Scholar