Ed. Bateman et al., SALMETEROL FLUTICASONE COMBINATION INHALER - A NEW, EFFECTIVE AND WELL TOLERATED TREATMENT FOR ASTHMA/, Clinical drug investigation, 16(3), 1998, pp. 193-201
Objective: The efficacy and tolerability of a new combination inhaler
containing both salmeterol 50 mu g and fluticasone 100 mu g in a singl
e device was compared with the delivery of the two drugs via two separ
ate inhalers in a multicentre, double-blind, double-dummy study. Patie
nts: 244 symptomatic asthma patients (age range 12 to 78 years) were r
andomised to a 12-week treatment period with either salmeterol/flutica
sone (50/100 mu g twice daily) via a single inhaler (combination) and
placebo twice daily via another, or salmeterol 50 mu g twice daily via
one inhaler and fluticasone 100 mu g twice daily via another (concurr
ent). Results: Morning peak expiratory flow rate (PEFR), symptoms and
tolerability were collected throughout the treatment period. Adjusted
mean improvements in morning PEFR were 42 and 33 L/min for combination
and concurrent therapies, respectively, over the 12-week treatment pe
riod. Adjusted mean improvements in forced expiratory volume in 1 seco
nd (FEV1) from baseline at week 12 were 0.20 and 0.17L for combination
and concurrent therapies, respectively. 60% of patients receiving com
bination inhaler and 64% of those receiving concurrent therapy had a m
ean daytime symptom score of zero over the treatment period compared w
ith 17 and 15%, respectively, at baseline. Both treatments were well t
olerated. Geometric mean morning serum cortisol levels were similar an
d no differences in the frequency of abnormal results were noted betwe
en the two groups. Conclusion: This was the first study reporting the
control of asthma by administration of salmeterol and fluticasone in c
ombination via a single inhaler. The new combination inhaler was as ef
fective and well tolerated as the two drugs administered individually
and has potential advantages in terms of convenience.