Efficacy and safety of ketotifen in young children with asthma

Area of Science:

• Pediatric Pulmonology
• Clinical Pharmacology

Background:

• Asthma is a common chronic respiratory disease in children.
• Ketotifen is an antihistamine and mast cell stabilizer used for asthma prophylaxis.

Purpose of the Study:

• To evaluate the prophylactic effect of ketotifen versus placebo in children aged 1 to 3 years with mild to moderate asthma.
• To assess symptom control, medication usage, and side effects associated with ketotifen therapy in this pediatric population.

Main Methods:

• A 28-week, double-blind, crossover study involving 30 children (1-3 years) with mild to moderate asthma.
• Data collection included patient daily diaries for symptoms and concomitant medications, alongside physician assessments at regular intervals.
• A 2-week baseline, 12-week treatment/placebo periods, and a 2-week washout phase were implemented.

Main Results:

• No statistically significant differences were found between ketotifen and placebo in tested asthma parameters.
• A reduction in concomitant medication use was noted during the initial ketotifen treatment phase.
• Weight gain was the primary observed side effect of ketotifen in this age group; sedation was not reported.

Conclusions:

• Ketotifen demonstrated no significant prophylactic benefit over placebo for mild to moderate asthma in young children (1-3 years).
• While weight gain was a notable side effect, the absence of sedation is a key finding differentiating from adult studies.