Asthma
Conditions
Brief summary
A clinical study explores the safety and efficacy of montelukast and to compare the safety and efficacy of montelukast with those of theophylline in pediatric bronchial asthma patients when they are used in conjunction with inhaled steroids.
Interventions
DRUGmontelukast
montelukast 5 mg QD 4-weeks.
DRUGTheophylline
Theophylline 100 to 200 mg BID 4-weeks.
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric Bronchial Asthma Patients Aged 6 To 14 Years (At The Beginning Of The Treatment Period) * The Severity Must Be Mild, Moderate Or Severe, Persistent Bronchial Asthma * The Patient Must Have Symptoms That Can Be Used As Efficacy Variables (Such As Repeated Coughing And Mild Or Moderate Asthma Attacks) During The Observation Period, And Must Be Using Inhaled Steroids
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 AM PEF over first 2 Weeks | Over first 2 Weeks |
Outcome results
None listed