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(Chest. 2006;130:1733-1743.)
© 2006 American College of Chest Physicians

Budesonide/Formoterol Maintenance Plus Reliever Therapy*

A New Strategy in Pediatric Asthma

Hans Bisgaard, MD, DMSci; Pascal Le Roux, MD; Ditlef Bjåmer, MD; Andrzej Dymek, MD; Jan H. Vermeulen, FCP (Paediatrics) and Christer Hultquist, MD{dagger}

* From the Department of Pediatrics (Dr. Bisgaard), Copenhagen University Hospital, Copenhagen, Denmark; Service de Pédiatrie (Dr. Le Roux), Groupe Hospitalier du Havre, Le Havre, France; Poliklinikk for Asthma and Allergy (Dr. Bjåmer), Bekkestua, Norway; Medical Center of Lucyna and Andrzej Dymek (Dr. Dymek), Zawadzkie, Poland; Department of Pediatrics (Dr. Vermeulen), Panorama Mediclinic, Cape Town, South Africa; and AstraZeneca R&D (Dr. Hultquist), Lund, Sweden. {dagger} See Appendix for additional participating investigators.

Correspondence to: Hans Bisgaard, MD, Danish Pediatric Asthma Center, Department of Pediatrics, Copenhagen University Hospital, Gentofte, DK-2900 Copenhagen, Denmark; e-mail: bisgaard{at}copsac.dk

Abstract

Objectives: A fixed combination of long-acting ß2-agonists (LABA) plus inhaled corticosteroids (ICS) has never been proven to reduce asthma exacerbations vs ICS alone in children. This 12-month, double-blind, randomized study in 341 children (age range, 4 to 11 years) with asthma uncontrolled on ICS investigated whether a novel regimen using budesonide/formoterol for maintenance and reliever therapy (Symbicort maintenance and relief therapy [SMART]) [Symbicort; AstraZeneca R&D; Lund, Sweden] could reduce exacerbations.

Methods: Patients received SMART (budesonide/formoterol 80/4.5 µg qd maintenance plus additional inhalations for symptom relief), budesonide/formoterol 80/4.5 µg qd for maintenance (fixed combination), or higher-dose budesonide 320 µg qd (fixed-dose budesonide). Blinded as-needed medication (terbutaline 0.4 µg) was provided in both fixed-dose groups.

Results: SMART prolonged the time to first exacerbation vs fixed-dose budesonide (p = 0.02) and fixed-dose combination (p < 0.001). Rates of exacerbation requiring medical intervention were reduced by 70 to 79% with SMART vs fixed-dose budesonide and fixed-dose combination (0.08/patient vs 0.28/patient and 0.40/patient, respectively; both p < 0.001). Mild exacerbation days and awakenings were significantly lower with SMART; yearly growth improved by 1.0 cm vs fixed-dose budesonide (p < 0.01).

Conclusion: The SMART regimen using budesonide/formoterol for both maintenance and as-needed symptom relief reduces the exacerbation rate compared with both fixed-dose combination and higher fixed-dose ICS alone in children with asthma.

Key Words: asthma • budesonide/formoterol • inhaled corticosteroids • long-acting ß2-agonist • pediatric • Symbicort






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Copyright © 2006 by the American College of Chest Physicians.