Regular Article
Addition of salmeterol to fluticasone propionate treatment in moderate-to-severe asthma

https://doi.org/10.1053/rmed.2003.1483Get rights and content
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Abstract

This study was designed to determine whether the benefit of adding salmeterol was superior to doubling the dose of fluticasone propionate (FP) over 6 months, compared to a control group who remained on a lower dose of FP. The multi-centre, double-blind, parallel group study involved 496 symptomatic asthmatic patients with a history of exacerbations on 500–800 micrograms (μg) inhaled corticosteroids (ICS) twice daily (b.d.) in a broadly representative group of 100 hospitals and general practices in six countries. Two doses of FP—250 μg b.d. (FP250) or 500 μg b.d. (FP500)—were compared with the lower dose of FP plus a long-acting β2-agonist, salmeterol 50 μg b.d. (SM/FP250). Patients symptomatic on the run-in dose of FP250 alone formed the control group in the treatment period. Over 6 months, SM/FP250 significantly improved mean morning peak expiratory flow rates (amPEF) by 42.1l/min, more than twice the improvement achieved with either dose of FP alone. SM/FP250 also resulted in more symptom-free days and nights (P<0.002) and days and nights with no relief medication (P<0.001). The number of severe exacerbations was low: 3, 6 and 8% in the SM/FP250, low- and high-dose FP groups, respectively. This study confirms that adding salmeterol to low-dose inhaled FP offers greater improvements than either maintaining or doubling the dose of FP. Significant benefit was gained from adding salmeterol in a group of patients who appeared to have been at the top of their steroid dose–response curve receiving FP250. There was no evidence of tolerance and a low incidence of exacerbations in all treatment groups.

Keywords

salmeterol
fluticasone
asthma.

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Correspondence should be addressed to: Dr P.W. Ind, Hammersmith Hospital, Ducane Road, London, W120NN, UK. Fax: +44-20-8743-9733 E-mail address: [email protected] (P. W. Ind)