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Original Research: ASTHMA |

Budesonide/Formoterol in a Single Inhaler for Maintenance and Relief in Mild-to-Moderate Asthma*: A Randomized, Double-Blind Trial

Klaus F. Rabe, MD, PhD; Emilio Pizzichini, MD, PhD; Björn Ställberg, MD; Santiago Romero, MD; Ana M. Balanzat, MD; Tito Atienza, MD; Per Arve Lier, MD; Carin Jorup, MD
Author and Funding Information

*From the University of Leiden (Dr. Rabe), Leiden, the Netherlands; the University Hospital of Florianópolis (Dr. Pizzichini), Florianópolis, Brazil; the Uppsala University (Dr. Ställberg), Uppsala, Sweden; the Hospital General de Alicante (Dr. Romero), Alicante, Spain; the Hospital de Clinicas “Jose de San Martin” (Dr. Balanzat), Buenos Aires, Argentina; the Mary Mediatrix Medical Center (Dr. Atienza), Lipa City, Philippines; the Humana Medical Centre (Dr. Lier), Sandvika, Norway; and AstraZeneca R&D (Dr. Jorup), Lund, Sweden.

Correspondence to: Klaus F. Rabe, MD, PhD, Department of Pulmonology, C3-P, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, the Netherlands; e-mail: K.F.Rabe@lumc.nl



Chest. 2006;129(2):246-256. doi:10.1378/chest.129.2.246
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Study objective: To compare a novel asthma management strategy—budesonide/formoterol in a single inhaler for both maintenance therapy and symptom relief—with a higher dose of budesonide plus as-needed terbutaline.

Methods: This was a 6-month, randomized, double-blind, parallel-group study in patients with mild-to-moderate asthma (n = 697; mean age, 38 years [range, 11 to 79 years]; mean baseline FEV1, 75% of predicted; mean inhaled corticosteroid [ICS] dosage, 348 μg/d). Following a 2-week run-in period, all patients received two blinded, dry powder inhalers, one containing maintenance medication and one containing medication to be used as needed for the relief of symptoms. Patients were randomized to receive either budesonide/formoterol (80 μg/4.5 μg, two inhalations qd) for maintenance plus additional inhalations as needed for symptom relief, or budesonide (160 μg, two inhalations qd) for maintenance medication plus terbutaline (0.4 mg) as needed. The primary efficacy variable was morning peak expiratory flow (PEF).

Results: Patients receiving budesonide/formoterol showed greater improvements in morning PEF than patients receiving budesonide (increases of 34.5 L/min vs 9.5 L/min, respectively; p < 0.001). The risk of having a severe exacerbation (hospitalization/emergency department [ED] treatment, oral steroids for asthma, or a ≥ 30% decrease from baseline in morning PEF on 2 consecutive days) was 54% lower with budesonide/formoterol vs budesonide (p = 0.0011). Budesonide/formoterol patients experienced 90% fewer hospitalizations/ED treatments due to asthma than budesonide patients (1 vs 10, respectively; p = 0.026). The increased efficacy with budesonide/formoterol was achieved with less ICS than was used in the budesonide group (mean dose, 240 μg/d vs 320 μg/d, respectively) and with 77% fewer oral steroid treatment days vs budesonide (114 days vs 498 days, respectively). Both treatments were well tolerated.

Conclusions: Budesonide/formoterol for both maintenance and relief improves asthma control with a lower steroid load compared with a higher dose of budesonide plus terbutaline.

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