Efficacy of salmeterol xinafoate in the treatment of COPD.
OBJECTIVE
To examine and compare the efficacy and safety of salmeterol xinafoate, a long-acting inhaled beta2-adrenergic agonist, with inhaled ipratropium bromide and inhaled placebo in patients with COPD.


METHODS
A stratified, randomized, double-blind, double-dummy, placebo-controlled, parallel group clinical trial.


METHODS
Multiple sites at clinics and university medical centers throughout the United States.


METHODS
Four hundred eleven symptomatic patients with COPD with FEV1 < or = 65% predicted and no clinically significant concurrent disease.


METHODS
Comparison of inhaled salmeterol (42 microg twice daily), inhaled ipratropium bromide (36 microg four times a day), and inhaled placebo (2 puffs four times a day) over 12 weeks.


RESULTS
Salmeterol xinafoate was significantly (p < 0.0001) better than placebo and ipratropium in improving lung function at the recommended doses over the 12-week trial. Both salmeterol and ipratropium reduced dyspnea related to activities of daily living compared with placebo; this improvement was associated with reduced use of supplemental albuterol. Analyses of time to first COPD exacerbation revealed salmeterol to be superior to placebo and ipratropium (p < 0.05). Adverse effects were similar among the three treatments.


CONCLUSIONS
These collective data support the use of salmeterol as first-line bronchodilator therapy for the long-term treatment of airflow obstruction in patients with COPD.
Mahler
D A
DA
Dartmouth Medical School, Lebanon, NH, USA. Donald.a.mahler@hitchcock.org
Donohue
J F
JF
Barbee
R A
RA
Goldman
M D
MD
Gross
N J
NJ
Wisniewski
M E
ME
Yancey
S W
SW
Zakes
B A
BA
Rickard
K A
KA
Anderson
W H
WH
D000280:Administration, Inhalation; D000318:Adrenergic beta-Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D000420:Albuterol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D009241:Ipratropium / Q000008:administration & dosage; D008173:Lung Diseases, Obstructive / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D000068299:Salmeterol Xinafoate; D014797:Vital Capacity
D000318:Adrenergic beta-Agonists; D001993:Bronchodilator Agents; D000068299:Salmeterol Xinafoate; D009241:Ipratropium; D000420:Albuterol