Montelukast Post-Marketing Comparative Study With Theophyline Added to Inhaled Corticosteroid - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00756418

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: montelukast Drug: Theophylline	Phase IV

MedlinePlus related topics: Asthma

Drug Information available for: Theophylline Montelukast sodium Montelukast Theophylline sodium glycinate Corticosteroids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Open-Label Comparative Study of Montelukast Versus Theophylline Added to Inhaled Corticosteroid in Pediatric Patients With Bronchial Asthma

Further study details as provided by Merck:

Primary Outcome Measures:

Improvement of AM PEF over first 2 Weeks [ Time Frame: Over first 2 Weeks ] [ Designated as safety issue: No ]

Enrollment:	84
Study Start Date:	June 2003
Primary Completion Date:	August 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: montelukast montelukast 5 mg QD 4-weeks.
2: Active Comparator	Drug: Theophylline Theophylline 100 to 200 mg BID 4-weeks.

Eligibility

Ages Eligible for Study:	6 Years to 14 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756418

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_027, MK0476-396
Study First Received:	September 19, 2008
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00756418 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Vasodilator Agents
Bronchial Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Asthma
Anti-Asthmatic Agents
Cardiovascular Agents
Hormones
Leukotriene Antagonists
Montelukast

Lung Diseases, Obstructive
Hypersensitivity
Phosphodiesterase Inhibitors
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity
Theophylline

Additional relevant MeSH terms:

Respiratory System Agents
Vasodilator Agents
Bronchial Diseases
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses
Immune System Diseases
Asthma

Anti-Asthmatic Agents
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions
Montelukast
Phosphodiesterase Inhibitors
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Theophylline
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 07, 2009