The combination of nebulized sodium cromoglycate and salbutamol in the treatment of moderate-to-severe asthma in children

The aim of this multi-centre prospective study was to evaluate the efficacy, tolerability, and safety of the combination of sodium cromoglycate (SCG) and salbutamol (administered as a nebulized solution), compared to SCG alone and salbutamol alone, in the management of severe, intractable asthma in childhood. The study was an open, randomized, cross-over trial of 12 weeks' duration in children with moderate-to-severe intractable asthma. All treatments were administered twice daily by powered nebulizer. The primary outcome measure was the change in asthma severity, as measured by the mean asthma score during the last 2 weeks of a baseline period and the last 2 weeks of each treatment. Secondary outcome measure was the patient's opinion of the effectiveness of treatment. The change in asthma scores from baseline values were significantly greater with the combination treatment compared to each component administered separately. The mean difference in asthma score between the combination and salbutamol was: -7.5; 95% CI, -11.70 to -3.29 (p < 0.0001). The mean difference between the combination and SCG was: -8.53; 95% CI, -14.03 to -3.25 (p < 0.0001). Patients were also significantly in favor of combination treatment (p < 0.001 vs. salbutamol; p < 0.01 vs. SCG). Two patients reported adverse effects. We concluded that regular twice-daily inhalation of a combination of SCG and salbutamol gave better control of symptoms than previous treatments in patients with severe, intractable asthma. Few adverse effects with this therapy suggest that it is extremely useful, safe, and effective.