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clinmed/2000030001v1 (March 21, 2000)
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The treatment of moderate to severe asthma in children with a combination of nebulised sodium cromoglycate and salbutamol
Kenshi Furusho, Kiyoshi Nishikawa, Sei Sasaki, Toru Akasaka, Masahiko Arita, and Alan Edwards
Background: The management of severe, intractable asthma in childhood still presents the clinician with difficult challenges despite the availability of modern drugs. Following reports of good results using the combination of nebulised sodium cromoglycate with Beta-2 agonists, the Severe Asthma Inhalation Research Committee of Japan organised a multicentre trial of this treatment in children with moderate to severe asthma.
Objectives: To investigate the relative efficacy, tolerability and safety of the combination of sodium cromoglycate and salbutamol in the treatment of moderate and severe childhood asthma.
Methods: Open, randomised, crossover trial of 12 weeks duration, comparing the combination of sodium cromoglycate and salbutamol with salbutamol alone and with sodium cromoglycate alone. All treatments administered twice daily by powered nebuliser. Main outcome measures were the change in asthma score, and the patient’s opinion of treatment.
Results: The change in asthma scores from baseline values significantly in favour of the combination. When compared to salbutamol, mean difference -7.5, 95% CI –11.70 to-3.29 ( p<0.0001). When compared to sodium cromoglycate, mean difference -8.53, 95% CI –14.03 to -3.25 (p <0.0001). Patient opinions also significantly in favour of combination treatment (p<0.001 v salbutamol; p <0.01 v sodium cromoglycate). Two patients reported adverse effects.
Conclusions: Regular twice daily inhalation of a combination of sodium cromoglycate and salbutamol gave better control of symptoms than previous treatments in patients with severe, intractable asthma. Few adverse effects with this therapy suggest it is extremely useful, safe and effective.