Comparison of nebulised sodium cromoglycate and oral theophylline in controlling symptoms of chronic asthma in pre-school children: a double blind study.

The efficacy of nebulised sodium cromoglycate and an oral theophylline solution at currently recommended doses were compared in one to six-year-old children with chronic asthma. Twenty-six children completed a 24-week double-blind trial of treatment with sodium cromoglycate (SCG), theophylline and a combination of both. The three regimens were administered, each for eight weeks, in a random sequence. SCG was administered by inhalation as a nebulised solution in standard doses of 20 mg qid and serum drug concentrations were recorded. Theophylline was given as liquid aminophylline. Dosage was individualised with the assistance of serum theophylline measurements and averaged 6.1 mg/kg/dose q6h. Patients had an average of 61% symptom-free days while on SCG and combination regimens, compared with only 46.5% for days free of symptoms when on theophylline alone (p less than 0.05). There was significantly less use of supplementary medication for acute symptoms (p less than 0.05) when on the combination of SCG and theophylline. No regimen was more frequently associated with symptoms of exercise intolerance or decreased appetite. Numerous adverse side effects to theophylline were recorded, but none were recognised with SCG. SCG is at least as effective as theophylline in controlling asthmatic symptoms in the 1-6-year-old age group.

RCT Entities:   Population Interventions Outcomes