Montelukast Post-Marketing Comparative Study With Ketotifen (0476-379)

Montelukast, on Pediatric Bronchial Asthma in Multicenter Comparative Double-Blind Clinical Study (Phase IV) With Ketotifen Fumarate

The clinical study evaluates the safety of montelukast and compares montelukast to ketotifen, used as a control drug, in terms of improvement in morning peak expiratory flow (am pef) over first 2 weeks in patients with pediatric bronchial asthma aged 6 to < 15.

The effect of body weight on the efficacy and safety of montelukast will also be evaluated in this study.

Inclusion Criteria:

• Intermittent asthma, mild persistent asthma, moderate persistent asthma, or severe persistent asthma patients with 2 or more mild or moderate attacks at baseline

Exclusion Criteria:

• Patient using anti-asthma treatment or therapy including corticosteroids or oral anti-allergic drugs
• Patient with complications that will impair the judgment of efficacy of this drug
• Patient with convulsive disorders such as epilepsy or such a history
• Patient with liver disease, renal impairment, heart disease or such other complication