Efficacy and tolerability of Ketotifen in Nepalese asthmatic children: a clinical study.

OBJECTIVE To assess the efficacy of Ketotifen in asthmatic children and to record its adverse effects, if any. DESIGN Prospective clinical trial. SETTING Pediatric asthma follow up clinic of a teaching hospital. PARTICIPANTS 23 asthmatic children between 3 and 15 years; 100% completed the trial on full protocol. INTERVENTIONS Ketotifen 1mg (adjusted according to body weight, 50 mcg/kg/dose) orally twice daily for 9 months. MAIN OUTCOME MEASURES PRIMARY OUTCOME Decrease in frequency of asthmatic attacks and severity of exacerbations with improvements in peak expiratory flow rates (PEFR). Other measures included decrease in bronchodilator requirement, steroid doses and parental perception regarding patient quality of life. RESULTS 34.78% children were symptom free by the end of 2nd 3 months and 65.21% had no further attack by the end of 3rd 3 months of Ketotifen prophylaxis. Those children with activity and sleep 'affected' (8.69%) and 'may be affected' (30.43%) together improved to 'may be affected' group (21.73%) by the end of 2nd 3 months and further reduced to 8.69% by the conclusion of 3rd 3 months. The duration of exacerbations was reduced in the remaining cases. Variability of PEFR decreased from 26.08% to 8.69% of children after the 3rd 3 months of Ketotifen prophylaxis. No significant adverse effect of therapy was observed during the study. CONCLUSION Oral Ketotifen is effective and well tolerated for use in prophylactic treatment of bronchial asthma in children.