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* From the Nelson R. Mandela School of Medicine (Dr. Lalloo), University of Natal, Durban, South Africa; Medical Academy (Dr. Malolepszy), Wroclaw, Poland; Korányi National Institute of Tuberculosis and Pulmonology (Dr. Kozma), Budapest, Hungary; Thomayer Teaching Hospital (Dr. Krofta), Prague, Czech Republic; Lund University Hospital (Dr. Ankerst), Lund, Sweden; University Hospital (Dr. Johansen), Oslo, Norway; and Western Infirmary (Dr. Thomson), Glasgow, United Kingdom.
Correspondence to: Umesh G. Lalloo, MD, FCCP, Nelson R. Mandela School of Medicine, University of Natal, Private Bag 7, Congella 4013, Durban, South Africa; e-mail: lalloo{at}nu.ac.za
Background: We evaluated the efficacy and safety of low-dose budesonide/formoterol, 80 µg/4.5 µg, bid in a single inhaler (Symbicort Turbuhaler; AstraZeneca; Lund, Sweden) compared with an increased dose of budesonide, 200 µg bid, in adult patients with mild-to-moderate asthma not fully controlled on low doses of inhaled corticosteroid alone.
Methods: All patients received budesonide, 100 µg bid, during a 2-week run-in period. At the end of the run-in phase, 467 patients with a mean FEV1 of 82% predicted received 12 weeks of treatment with budesonide/formoterol in a single inhaler or budesonide alone in a higher dose. Patients kept daily records of their morning and evening peak expiratory flow (PEF), nighttime and daytime symptom scores, and use of reliever medication.
Results: The increase in mean morning PEF—the primary efficacy measure—was significantly higher for budesonide/formoterol compared with budesonide alone (16.5 L/min vs 7.3 L/min, p = 0.002). Similarly, evening PEF was significantly greater in the budesonide/formoterol group (p < 0.001). In addition, the percentage of symptom-free days and asthma-control days (p = 0.007 and p = 0.002, respectively) were significantly improved in the budesonide/formoterol group. Budesonide/formoterol decreased the relative risk of an asthma exacerbation by 26% (p = 0.02) compared with budesonide alone. Adverse events were comparable between the two treatment groups.
Conclusion: This study shows that in adult patients whose mild-to-moderate asthma is not fully controlled on low doses of inhaled corticosteroids, single-inhaler therapy with budesonide and formoterol provides greater improvements in asthma control than increasing the maintenance dose of inhaled corticosteroid.
Key Words: asthma • budesonide • formoterol • inhaled corticosteroids • long-acting ß2-agonists • Symbicort
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