[Usefulness of salmeterol in nocturnal asthma: a comparative study with theophylline-ketotifen association. A French multicenter group].
Ninety-six patients with nocturnal asthma (FEV1 = 60-90% pred, reversibility greater than or equal to 15%, at least 2 awakenings in the week preceding the trial) were included in a double-blind, randomized, crossover, multicenter study which compared the efficacy and side effects of inhaled salmeterol (50 micrograms morning and evening) to the association theophylline-ketotifen (300 mg and 1 mg morning and evening, respectively). The trial included a run-in period of 14 days and 2 periods of successive treatment of 28 days each. The efficacy was expressed in terms of therapeutic success, defined by the total disappearance of nocturnal symptoms during the treatment week. A statistically significant difference (p less than 0.01) was found between salmeterol and the association for this criteria: during the first period, 46% of subjects treated by salmeterol did not present nocturnal awakenings during the last treatment week by comparison with 15% of subjects taking the association; during the second period, corresponding figures were 39% for salmeterol by comparison with 26% for the association. Differences were also significant, favoring salmeterol, for other criteria (lung function tests, extra-need for salbutamol). Side effects were 5 times more frequent for the association (p less than 0.004). Salmeterol is clearly superior to the association theophylline-ketotifen in the treatment of nocturnal asthma.
Service de Pneumologie, CHU de Rouen Hôpital de Bois-Guillaume.
J F
JF
Muir
D
D
Georges
D000293:Adolescent; D000318:Adrenergic beta-Agonists / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007665:Ketotifen / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D000068299:Salmeterol Xinafoate; D013806:Theophylline / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors
D000318:Adrenergic beta-Agonists; D000068299:Salmeterol Xinafoate; D013806:Theophylline; D000420:Albuterol; D007665:Ketotifen
Apport du salmétérol dans l'asthme nocturne: étude comparative à l'association théophylline LA-kétotifène. Groupe Multicentrique Français.