Comparative study of extended release albuterol sulfate and long-acting inhaled salmeterol xinafoate in the treatment of nocturnal asthma.
BACKGROUND
Nocturnal worsening of asthma is a common problem in asthma and is associated with increased morbidity and mortality. Long acting beta-2 agonists are considered long-term symptom control medications, especially for nocturnal symptoms.


OBJECTIVE
To compare efficacy of an extended release oral beta-2 agonist, albuterol sulfate (Volmax), to a long-acting inhaled agent, salmeterol (Serevent) in the treatment of nocturnal asthma.


METHODS
This was a multicenter double-blind, double-dummy, randomized, crossover design with a 1-week baseline period and two 3-week treatment periods separated by a 7 to 9-day washout. An optional 2-week, open-label phase was conducted to evaluate patient preference.


RESULTS
A total of 46 patients were included in the efficacy analysis. For the primary outcome variable of morning peak expiratory flow, there were similar and significant improvements over the 3-week treatment period for both medications compared with baseline (P < .001). Similar improvements were seen in the overnight change in PEF values (P < .001). The morning and overnight changes in FEV1 were not significantly different between treatment arms (P > .05). There were significant improvements in both treatment periods in regard to the percentage of nights without awakenings (baseline 53.6+/-5.3%), extended release albuterol 83.3+/-3.0% (P < .001), and salmeterol 88.8+/-2.4%. The percentage of patients who had no awakenings during treatment did not differ significantly for the two medications. Both treatments also resulted in a decrease in the use of rescue albuterol (extended release 2.66+/-0.35 puffs per day, salmeterol 1.85+/-0.29) from baseline (4.57+/-0.41, P < .001). There was a significant difference between groups (P = .001). The reasons why patients preferred one medication over the other varied.


CONCLUSIONS
Both extended release albuterol tablets and inhaled salmeterol resulted in similar bronchodilation and good control of nocturnal asthma symptoms.
Martin
R J
RJ
National Jewish Medical and Research Center, Denver, Colorado 80206, USA.
Kraft
M
M
Beaucher
W N
WN
Kiechel
F
F
Sublett
J L
JL
LaVallee
N
N
Shilstone
J
J
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D000568:Amenorrhea / Q000139:chemically induced; D001249:Asthma / Q000188:drug therapy*; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume; D006261:Headache / Q000139:chemically induced; D006339:Heart Rate; D006801:Humans; D008875:Middle Aged; D010366:Peak Expiratory Flow Rate; D000068299:Salmeterol Xinafoate; D013997:Time Factors
D003692:Delayed-Action Preparations; D000068299:Salmeterol Xinafoate; D000420:Albuterol