Asthma
Conditions
Brief summary
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.
Interventions
DRUGComparator: ketotifen / Duration of Treatment: 4 Weeks
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of morning peak expiratory flow over first 2 weeks | — |
Outcome results
None listed