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Ketotifen for asthma in children aged 5 to 15 years: a randomized placebo-controlled trial
S K Kabra1, R M Pandey, R Singh
1Department of Pediatrics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi.
Insights
Ketotifen, a prophylactic asthma medication, significantly reduced the need for antiasthma drugs and emergency visits in children aged 5-15. Clinical improvements were observed after 14 weeks of treatment.
Area of Science:
- Pediatric Pulmonology
- Clinical Pharmacology
- Asthma Management
Background:
- Previous studies on ketotifen for mild-to-moderate asthma showed benefits within 10-12 weeks.
- Limited data exists on the long-term efficacy of ketotifen in pediatric asthma patients beyond 12 weeks.
Purpose of the Study:
- To evaluate the efficacy of ketotifen (1 mg twice daily) as an oral prophylactic agent in children with asthma.
- To assess the drug's impact on asthma symptom scores, medication use, and emergency room visits over a 6-month period.
Main Methods:
- A 6-month, double-blind, placebo-controlled trial involving 120 children (5-15 years) with asthma.
- Participants received either ketotifen (1 mg BID) or placebo, with rescue antiasthma medications permitted.
- Outcome measures included antiasthma drug duration, symptom scores, symptom-free days, peak expiratory flow rate (PEFR), FEV1, and ER visits.
Main Results:
- Ketotifen group showed significantly fewer days requiring salbutamol, theophylline, and oral steroids compared to placebo.
- Average symptom scores improved, and symptom-free days increased in the ketotifen group.
- Emergency room visits were halved in the ketotifen group (10 vs. 20 visits, P < .05).
Conclusions:
- Ketotifen, 1 mg twice daily, is an effective prophylactic treatment for asthma in children aged 5-15 years.
- Significant clinical improvements in asthma control are observable after 14 weeks of ketotifen therapy.
- The study supports ketotifen's role in improving asthma management outcomes for pediatric patients.
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+/-3.5 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.