Montelukast Post-marketing Comparative Study With Theophyline Added to Inhaled Corticosteroid (0476-396)

• Status: Completed
• Trial end date: 2004-08-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Montelukast; Theophylline

Criteria

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