The addition of salmeterol 50 µg bid to anticholinergenic treatment in patients with COPD: A randomized placebo controlled trial
K Chapman | P Arvidsson | AG Chuchalin | DP Dhillon | P Faurschou | RS Goldstein | AF Kuipers
the past, the role of long-acting beta2-
agonists in chronic obstructive pulmonary disease (COPD)
relative to other agents has been unclear.
To compare the effect of adding salmeterol
(50 µg bid) or placebo to concurrent anticholinergic
therapy on symptom scores, quality of life, prebronchodilator
lung function and exacerbations in patients with moderately
This was a double-blind, randomized, parallel-group
study in patients aged 40 years or older receiving anticholinergic
medication. Patients were randomly assigned to treatment
with placebo (n=207) or salmeterol (n=201) via a Diskus/Accuhaler
inhaler for 24 weeks.
The morning trough (prestudy drug) forced expiratory
volume in 1 s (FEV1) increased significantly
above baseline levels among the salmeterol-treated patients.
Improvement in FEV1 was greater in the salmeterol
group than in the placebo group at four weeks (difference
0.06 L, P<0.005), eight weeks (0.06 L, P<0.005)
and 16 weeks (0.05 L, P<0.05) after the start of
treatment. There was a nonsignificant trend in favour
of salmeterol after 24 weeks of treatment (P=0.198).
Improvements in morning peak flow were significantly
greater in the salmeterol group over 24 weeks (P<0.01).
Although symptom scores were numerically higher in the
salmeterol group than in the placebo group and there
was less requirement for rescue bronchodilator use,
these differences were not statistically significant.
In the salmeterol group, fewer patients had exacerbations
of COPD, and there was a trend toward an improved quality
of life. The safety profile of the two groups was similar.
Salmeterol has a beneficial effect when added to existing
anticholinergic therapy in patients with COPD. The regular
use of salmeterol for six months was not associated
with worsening of the underlying airflow obstruction;
rather, there was a tendency for the trough FEV1
to improve above the baseline levels over the treatment