Source: Annual Congress 2002 - Asthma - Therapy and management -1
Disease area: Airway diseases

Abstract

Safety and effectiveness of formoterol Turbuhaler® (Oxis®) 4.5 μg (F) was compared with salbutamol 200 μg (S) as reliever. 18,124 asthma patients (10,384 women), aged 4–91 y, were randomised in this 6-month open study to reliever therapy of F or S. S was given by pMDI or dry powder inhaler depending on country. Existing maintenance therapy was varied at the clinician's discretion. Primary efficacy variable was time to first asthma exacerbation, defined as an asthma deterioration requiring: hospitalisation, emergency treatment, a course of oral corticosteroid or increased maintenance therapy (intention-to-treat analysis). F was safe to use as a reliever. Compared with S, F significantly reduced the risk of exacerbations (table), reduced use of maintenance and reliever therapy and decreased the percentage of days with symptoms. Oxis® as reliever therapy improves overall asthma control compared with salbutamol.

Variable	Hazard ratio F/S	p-value
All exacerbations*	0.861	<0.001
Severe exacerbations	0.880	0.0013
Hospitalisation +	0.841	0.841
Emergency treatment +	0.885	0.027
Oral corticosteroids +	0.870	0.0033
Increased maintenance	0.839	<0.001

*All exacerbations decreased by 14%
+ Classed as severe

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Formoterol turbuhaler compared with salbutamol as reliever medication in asthma: a worldwide, randomised, effectiveness trial (RELIEF Study). Eur Respir J 2002; 20: Suppl. 38, 391

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