Oral Prophylaxis of Bronchial Asthma in Children

Dr. V. Spicak, Department of Allergology, University Hospital, Prague-Motol (CSSR) In a controlled, double-blind study of 12 weeks duration the protective action of ketotifen in young children was compared with the effect of placebo and it was also determined whether concomitant therapy (steroids and/or bronchodilators) could be reduced. 50 children aged between 1 and 9 years with confirmed allergic bronchial asthma of 6 months to 6 years duration and with reversible bronchospasm were randomly divided into two comparable groups. In 34 children (15 on placebo, 19 on ketotifen) desensitization had previously been tried. No child was receiving other prophylactic treatment but all were taking /?2-stimulators and/or steroids. According to their body weight they received daily doses of 1, 1.5 or 2 mg of ketotifen. This was given in the form of scored tablets twice or three times a day, the same regimen applying to placebo tablets. At the beginning of the study the medical history was recorded and a general examination including full blood count and liver function tests (SGOT, SGPT, alkaline phosphatase) carried out. At weeks 2, 4, 8 and 12, the patients were assessed clinically, Extended abstract Full paper to be published elsewhere. and daily use of concurrent medication was recorded. At weeks 4, 8 and 12, blood was taken for laboratory tests. At the end of the study an overall assessment of efficacy and safety was made by the investigator. The definitions used were: very effective (symptoms hardly present, no more wheezing or asthma attacks and concomitant medication no longer required), effective (marked improvement, number of asthma episodes reduced by more than 50%, concomitant therapy reduced), weakly effective (slight improvement, number of asthma episodes hardly changed, concomitant medication unaltered), and ineffective (no improvement in symptoms, a change in therapy necessary). All 50 patients completed the study. In both groups there was a comparable improvement in dyspnoea and asthmatic complaints. The incidence of asthmatic attacks was significantly lower in the ketotifen group (mean 1.65 ± 2.1) as compared with the placebo group (mean 3.73 ± 3.6; p < 0.01) from week 8 onwards. 5 of the 6 children taking corticosteroids were in the ketotifen group and 4 were able to reduce their daily dosage, 3 ultimately discontinuing corticosteroids altogether. All the children were receiving /3⁄4-stimulants and whilst on ketotifen 17 reduced their daily Oral Prophylaxis of Bronchial Asthma in Children 19