Comparison of salmeterol with disodium cromoglycate in the treatment of adult asthma.
BACKGROUND
Disodium cromoglycate and salmeterol, a long acting beta 2-agonist, achieve their therapeutic effects through different mechanisms but both are used as maintenance therapies in asthma.


OBJECTIVE
It was the purpose of this study to assess the comparative efficacy and safety of both drugs when used as prophylactic therapy for adults with symptomatic mild to moderate asthma.


METHODS
In this 8-week, double-blind, double-dummy, parallel group, multicenter study, 134 adult patients with a forced expiratory volume in one second (FEV1) ranging from 60% to 90% predicted, reversibility in FEV1 of greater than 15% and a total daily symptom score of at least 2 or a diurnal variation in peak expiratory flow (PEF) of greater than 15% on three of the seven days of the run-in period, were randomized to either salmeterol, 50 microgram twice daily (via metered-dose inhaler), or disodium cromoglycate, 20 mg four times daily (via Spinhaler), plus corresponding placebo. Approximately 50% of the total population were concurrently receiving inhaled corticosteroids.


RESULTS
Salmeterol was significantly better than disodium cromoglycate in improving both morning (mean difference between treatments = 31 L/min; P = .007) and evening PEF (mean difference between treatments = 29 L/min; P = .008). Both treatments were however, associated with significant improvement in FEV1, daytime and night-time symptoms score and use of rescue salbutamol (P < .001). Although salmeterol tended to produce greater improvement than disodium cromoglycate in all these parameters only the difference in rescue salbutamol achieved statistical significance (P = .021). Salmeterol was the preferred treatment of both the patients and the physicians (P = .002). Both treatments were well tolerated with a similarly low incidence of adverse event reports, the majority of which were related to underlying disease.


CONCLUSIONS
Salmeterol, 50 microgram twice daily, provides better control of symptomatic mild to moderate asthma than disodium cromoglycate, 20 mg four times daily.
Bousquet
J
J
Hôpital Arnaud de Villeneuve, Service des Maladies Respiratoires, Montpellier, France.
Aubert
B
B
Bons
J
J
D000293:Adolescent; D000318:Adrenergic beta-Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018927:Anti-Asthmatic Agents / Q000009:adverse effects / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy*; D004205:Cromolyn Sodium / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000068299:Salmeterol Xinafoate
D000318:Adrenergic beta-Agonists; D018927:Anti-Asthmatic Agents; D000068299:Salmeterol Xinafoate; D004205:Cromolyn Sodium; D000420:Albuterol