Ketotifen versus inhaled budesonide for controlling childhood asthma.

BACKGROUND International asthma guideline recommends inhaled corticosteroids therapy for children of all ages as the first controller. However, in some less developed parts of the world, ketotifen, an old inexpensive medicine with antihistaminic and anti-allergic reactions, has been found to be the most favored prophylactic agents. OBJECTIVE To compare the efficacy and safety of ketotifen and inhaled budesonide in asthmatic children aged 8 months to 14 years at Banpong Hospital, located 80 km south from Bangkok. MATERIAL AND METHOD Children who had been admitted with acute asthmatic attack in 2008 at Banpong Hospital and had > 3 episodes of wheeze with good response to nebulized bronchodilators were randomized into two groups. Ketotifen group (n = 16) were given oral ketotifen 0.5 mg or 1 mg twice daily depending on age. Budesonide group (n = 14) were given as inhaled budesonide 200 microg (MDI) twice daily. Caregivers recorded children's asthmatic symptoms and nebulized treatments in diaries every day. The enrolled children received these two treatment regimens and were followed up for 26 weeks. RESULTS Number of ER visits decreased significantly after both treatments (p < 0.005). The percentage of children with reduction in ER visits was comparable between ketotifen and budesonide (p = 0.16). Ketotifen group also demonstrated a reduction in days of hospital stay (p < 0.05). Budesonide treatment resulted in more symptom-free days (p < 0.05). Both medications were well tolerated and safe. The only demonstrated side effect of ketotifen was weight gain. The growth rate in height for both groups did not differ. CONCLUSION Both ketotifen and inhaled budesonide are effective, safe, and well-tolerated in the prevention of asthma exacerbation in children particularly in the country with limited resource.