Comparison of Nebulised Sodium Cromoglycate and Oral Theophylline in Controlling Symptoms of Chronic Asthma in Pre-school Children: A Double Blind Study*

Abstract
The efficacy of nebulized sodium cromoglycate [SCG] and an oral theophylline solution at currently recommended doses were compared in 1-6 yr old children with chronic asthma. Children (26) completed a 24-wk double-blind trial of treatment with SCG, theophylline and a combination of both. The 3 regimens were administered, each for 8 wk, in a random sequence. SCG was administered by inhalation as a nebulized solution in standard doses of 20 mg qid [4 times/day] and serum drug concentrations were recorded. Theophylline was given as liquid aminophylline. Dosage was individualized with the assistance of serum theophylline measurements and averaged 6.1 mg/kg per dose every 6 h. 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 < 0.05). There was significantly less use of supplementary medication for acute symptoms (P < 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 recognized with SCG. SCG is at least as effective as theophylline in controlling asthmatic symptoms in the 1-6 yr old age group.