ADMINISTRATION OF HALF-DOSE THEOPHYLLINE TOGETHER WITH KETOTIFEN TO ASTHMATIC-CHILDREN - A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

Administration of theophylline to asthmatic children is frequently ass ociated with an adverse influence on their behavior. The efficacy and behavioral effects of the administration of high-dose theophylline (T) and ketotifen (K) in various combinations were evaluated prospectivel y in a double-blind, placebo controlled study in 55 children with mode rately severe perennial asthma. During a baseline period of 2 weeks, t heophylline (serum level of 10-20 mu g/ml) was administered to all the children. After this period the patients were randomly allocated into four comparable groups. The children were treated during a 12-week pe riod with: T + K-Placebo (T group); T + K (T + K group); half-dose T K (T/2 + K group); or placebo of both T and K (P group). During the 1 2-week treatment period, as compared to the baseline period, only the three groups of children who received active therapy (T + P, T + K, T/ 2 + K) showed a similar reduction in the number of days with asthmatic symptomatology, improvement of the total asthmatic symptoms score, an d increased PEFR. The behavioral activity of the children (assessed by the Conner's rating scale) improved significantly only in the groups receiving placebo or T/2 + K. The results of this study suggest that a combination therapy of half the recommended therapeutic dose of theop hylline with ketotifen can be clinically as effective as therapy with a full dose of theophylline, but with significantly less adverse behav ioral effects.