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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Montelukast

Drug

montelukast 5 mg QD 4-weeks.

Other names: MK0476

Theophylline

Drug

Theophylline 100 to 200 mg BID 4-weeks.

Primary outcomes

Improvement of AM PEF over first 2 Weeks

Time frame: Over first 2 Weeks

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Randomized Open-Label Comparative Study of Montelukast Versus Theophylline Added to Inhaled Corticosteroid in Pediatric Patients With Bronchial Asthma

Important dates

Study start: 2003
Primary completion: 2004
Study completion: 2004
First posted: Sep 22, 2008
Registry last updated: Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed