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Formoterol Turbuhaler as reliever medication in patients with acute asthma

¹ Depts of Respiratory Medicine, Royal Melbourne Hospital and Melbourne University, Melbourne, ² Dept of Thoracic Medicine, Royal Adelaide Hospital, Adelaide, ³ Dept of Emergency Medicine, Lyell McEwin Health Services, Elizabeth Vale, ⁴ Asthma and Allergy Research Institute, and Centre for Asthma, Allergy and Respiratory Research, Universtiy of Western Australia, Nedlands, and ⁵ AstraZeneca, Sydney, Australia, ⁶ AstraZeneca R&D, Lund, Sweden.

CORRESPONDENCE: A. R. Rubinfeld, Dept of Respiratory Medicine, Royal Melbourne Hospital, Grattan Street, Parkville, Victoria 3050, Australia. Fax: 61 393428493. E-mail: abe.rubinfeld{at}mh.org.au

Keywords: Acute asthma, formoterol, reliever medication, salbutamol, Turbuhaler®

Received: March 9, 2005
Accepted January 2, 2006

The aim of this study was to compare the efficacy and safety of formoterol versus salbutamol as reliever medication in patients presenting at an emergency dept with acute asthma.

A randomised, double-blind, double-dummy, parallel group study was performed in four Australian emergency treatment centres. The study included a total of 78 adult patients (mean baseline forced expiratory volume in one second (FEV₁) 1.83 L; 59% predicted) with acute asthma. Based on the expected dose equivalence of formoterol Turbuhaler® 4.5 µg (delivered dose) and salbutamol pressurised metered-dose inhaler 200 µg (metered dose), patients received a total of formoterol Turbuhaler® 36 µg (delivered) or salbutamol pressurised metered-dose inhaler with spacer 1,600 µg (metered), divided into two equal doses at 0 and 30 min. FEV₁, peak expiratory flow and systemic ß₂-agonist effects were monitored for 4 h. The primary variable was FEV₁ % pred at 45 min.

At 45 min, mean increases in FEV₁ expressed in % pred were 6.6% and 9.3%, respectively, with a small adjusted mean difference in favour of salbutamol (3.0%, 95% confidence interval –2.0–8.0). Transient increases in systemic ß₂-agonist effects occurred predominantly with salbutamol, although no significant treatment differences were observed. Eight patients discontinued due to adverse events.

In this study of patients presenting at emergency depts with acute asthma, formoterol Turbuhaler® 36 µg was well tolerated and, as rescue therapy, had an efficacy that was not different from that of salbutamol pressurised metered-dose inhaler with spacer 1,600 µg in the number of patients studied.

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