Salmeterol xinafoate as maintenance therapy compared with albuterol in patients with asthma.
OBJECTIVE
To compare the efficacy and safety of inhaled salmeterol xinafoate, a long-acting beta 2-adrenoceptor agonist, with that of albuterol, a short-acting inhaled beta 2-agonist, in the treatment of asthma.


METHODS
Randomized, double-blind, placebo-controlled, parallel-group study.


METHODS
Eleven outpatient clinical centers.


METHODS
A total of 322 male and female patients at least 12 years of age with chronic symptomatic asthma requiring daily therapy.


METHODS
Patients were treated with salmeterol xinafoate (42 micrograms inhaled twice daily), albuterol (180 micrograms inhaled four times daily), or placebo (four times a day) for 12 weeks; patients in all three groups could use inhaled albuterol as backup medication for breakthrough symptoms.


METHODS
Serial 12-hour forced expiratory flow in 1 second (FEV1), peak expiratory flow (PEF), asthma symptoms, nocturnal awakenings due to asthma, episodes of asthma exacerbations, and electrocardiography.


RESULTS
The mean area under the curve for FEV1 throughout each 12-hour period was consistently greater after a single dose of salmeterol than after two doses of albuterol administered 6 hours apart (P < .001), with the difference ranging from 3.1 to 4.3 L.h. Salmeterol produced an average increase in morning and evening PEF of 26 and 29 L/min, respectively, over pretreatment values compared with decreases of -13 and -3 L/min, respectively, in the albuterol group and -2 L/min both in the morning and evening in the placebo group (P < .001). Patients in the salmeterol group had significantly fewer days and nights with symptoms than did either the albuterol or placebo group (P < .001). Responses to salmeterol were similar at day 1 and at week 12. Adverse events in all treatment groups were equally infrequent, and no clinically significant change in cardiac rhythm was observed with salmeterol treatment.


CONCLUSIONS
Salmeterol inhaled twice daily is more effective than albuterol inhaled four times a day (or as needed) in patients with asthma requiring maintenance therapy. No deterioration of asthma control was observed with the use of salmeterol over a 3-month period.
D'Alonzo
G E
GE
University of Texas Health Science Center, Houston.
Nathan
R A
RA
Henochowicz
S
S
Morris
R J
RJ
Ratner
P
P
Rennard
S I
SI
D000280:Administration, Inhalation; D000293:Adolescent; D000318:Adrenergic beta-Agonists / Q000008:administration & dosage / Q000627:therapeutic use*; D000328:Adult; D000420:Albuterol / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002908:Chronic Disease; D002940:Circadian Rhythm; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004562:Electrocardiography; D015716:Electrocardiography, Ambulatory; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D010366:Peak Expiratory Flow Rate; D012129:Respiratory Function Tests; D000068299:Salmeterol Xinafoate
D000318:Adrenergic beta-Agonists; D001993:Bronchodilator Agents; D000068299:Salmeterol Xinafoate; D000420:Albuterol