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

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: montelukast; Drug: Theophylline

• Registration Number: NCT00756418
• Lead Sponsor: Organon and Co

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06-01
• Primary Completion: 2004-08-28
• Study Completion: 2004-08-28
• Study First Submitted: 2008-09-19
• Study First Submitted QC: 2008-09-19
• Study First Posted: 2008-09-22
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	montelukast	-
2	Theophylline	-

Primary Outcome Measures

Name	Time	Method
Improvement of AM PEF over first 2 Weeks	Over first 2 Weeks