Budesonide/Formoterol Maintenance and Reliever Therapy versus Free-Combination Therapy for Asthma: A Real-Life Study

Abstract

Background: This non-interventional real-life study (NCT00884689) compared budesonide/formoterol (Symbicort^®) maintenance and reliever therapy (SMART™) with a free combination of inhaled corticosteroid (ICS) + long-acting β₂-agonist (LABA) (in separate inhalers) and as-needed short-acting β₂-agonist (SABA) in adult asthma patients with an exacerbation in the past 24 months.

Methods: Asthma patients received SMART™ or free-combination ICS + LABA and as-needed SABA for 6 months. Allocation of patients and doses prescribed were at physician’s discretion. No other restrictions applied. Primary endpoint: mean no. of rescue medication puffs/day.

Results: 482 patients were included (SMART™ n = 310; free combination n = 172). SMART™ patients used less rescue medication vs the free-combination group (mean difference – 0.27 puffs/day; p = 0.013). Severe asthma exacerbations were rare (mean rate 0.20 vs 0.17/year for SMART™ vs free combination). The mean ICS dose was 615 µg in SMART™ and 678 µg in free-combination group.

Conclusions: In this real-life setting, SMART™-treated patients used less rescue medication despite a lower ICS burden vs conventional asthma management with three different inhalers.

Zusammenfassung

Hintergrund: Diese nicht-interventionelle Studie (NCT00884689) verglich Budesonid/Formoterol (Symbicort® maintenance and reliever therapy, SMART™) mit der freien Kombination eines inhalativen Kortikosteroids (ICS) und langwirksamem Beta2-Sympathomimetikums (LABA) in separaten Inhalatoren in Verbindung mit einem kurzwirksamen Beta2-Sympathomimetikum (SABA) als Bedarfsmedikation.

Methode: Die Zuteilung von erwachsenen Patienten und die verschriebene Dosis lagen im Ermessen des Arztes. Primärer Endpunkt war die mittlere Anzahl der Hübe der Notfallmedikation pro Tag.

Ergebnisse: 482 Patienten wurden in die Studie eingeschlossen (SMART™ n = 310; freie Kombination n=172). Die SMART™ Gruppe verwendete weniger Notfallmedikation als die freie Kombinationsgruppe (mittlere Differenz – 0,27 Hübe/Tag; p = 0,013). Schwerwiegende Asthma-Exazerbationen waren selten (mittlere Rate 0,20 vs. 0,17/Jahr für SMART™ vs. freie Kombination). Die mittlere ICS-Dosis (BDP Äquivalent) betrug 615 µg (SMART™-Gruppe) und 678 µg (freie Kombination).

Schlussfolgerung: Unter Alltagsbedingungen im Vergleich zur freien Kombination verwendeten Patienten unter SMART™ Regime, trotz einer geringeren ICS-Gesamtdosis, weniger Notfallmedikation.

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