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In international guidelines inhaled corticosteroids are considered the primary treatment for persistent asthma 1 and inhaled short acting [beta]2 agonists are recommended for relief of symptoms as needed. If patients remain symptomatic two of the available options are to increase the dose of inhaled corticosteroids or to add a long acting [beta]2 agonist.
Inhaled corticosteroids have been shown to improve lung function and symptoms, to decrease airway hyperresponsiveness, and to reduce the number of asthma exacerbations. 1-4 Long acting inhaled [beta]2 agonists have been shown to improve lung function and symptom score, to decrease nocturnal asthma, and to decrease the need for short acting [beta]2 agonists. 5 6 On the other hand, the regular use of short acting [beta]2 agonists has been associated with less good asthma control and an increase in the number of exacerbations. 7 Accordingly, there are concerns that maintenance therapy with long acting [beta]2 agonists could lead to deterioration of asthma control. Recently, however, three large trials by Greening et al , 8 Woolcock et al , 9 and Pauwels et al 10 have reported that the combination of the long acting [beta]2 agonists salmeterol or formoterol with the inhaled corticosteroids beclomethasone dipropionate (BDP) or budesonide (BUD) provide better improvement in lung function and symptom control, without increasing the exacerbation rate, than doubling the dose of the inhaled corticosteroid.
To date no studies have been performed using the combination of salmeterol (SLM) and fluticasone propionate (FP). This study was therefore undertaken to compare the effects on lung function and symptom control of adding salmeterol or doubling the dose of FP in asthmatic subjects still symptomatic on a low or intermediate dose of inhaled corticosteroids.
Methods
PATIENTS
Asthmatic patients aged at least 18 years and receiving 400-600[mu]g BDP or 800-1200[mu]g BUD daily were recruited to the study. Patients were excluded if they had changed their asthma medication in the preceding six weeks, had used oral steroids in the previous three months, had an upper or lower respiratory tract infection requiring antibiotic treatment, or had been admitted to hospital for their asthma in the previous month.
The study was performed at 27 centres in The Netherlands and was approved by the medical ethics committee of each...