Status:
COMPLETED
Montelukast Post-marketing Comparative Study With Theophyline Added to Inhaled Corticosteroid (0476-396)
Lead Sponsor:
Organon and Co
Conditions:
Asthma
Eligibility:
All Genders
6-14 years
Phase:
PHASE4
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 u...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2004
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00756418
Start Date
June 1 2003
End Date
August 28 2004
Last Update
August 15 2024
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