Ketotifen for asthma in children aged 5 to 15 years: a randomized placebo-controlled trial

Background: The prophylactic agent ketotifen has been studied in mild-to-moderate asthma. Various trials showed benefit from 10 to 12 weeks of therapy, but no trial in children with followup beyond 12 weeks of the drug is available. Objectives: We studied the efficacy of ketotifen, 1 mg twice a day, orally as a prophylactic drug in children with asthma. Methods: The double-blind, placebo-controlled trial studied 120 asthmatic children of either sex between the ages of 5 to 15 years at a tertiary care hospital. After an observation period of 4 weeks, children were randomly assigned to receive either ketotifen, 1 mg twice a day, or placebo for 6 months. Antiasthma drugs were continued as required. Main outcome measures included average duration for regular antiasthma drugs, average symptom scores, symptom free days, peak expiratory flow rate, FEV1, and need for emergency room visits. Results: Of the 120 children enrolled, 13 could not complete the trial. Thus 58 children remained in the treatment group and 49 were in the placebo group. Both groups were comparable in their baseline characteristics. The average number of days that required antiasthma drugs were significantly less in the treatment group: salbutamol (27 +/- 4.7 versus 37 +/- 35 P < .05), theophylline (37 +/- 4.7 versus 51 +/- 4.8 P < .05), oral steroids (2 +/- 0.4 versus 5 +/- 1.6 P < .05), and inhalation steroids (18 +/- 2.7 versus 16 +/- 10.8 P < .05). The average symptom scores and symptom free days for cough, wheeze, and breathlessness also favored the ketotifen group. Emergency room visits were also significantly lower in the ketotifen group (20 versus 10 P < .05). Statistically significant improvement in all the above parameters were observed after 14 weeks of therapy. The mean PEFR, FEV1 and side effects of medications were comparable between the two groups. Conclusions: Ketotifen, 1 mg twice a day, is an effective prophylaxis for asthma in children between 5 to 15 years. Significant clinical improvement is evident after 14 weeks of therapy.