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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: September 19, 2008
Last updated: April 24, 2015
Last verified: April 2015
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
Drug: montelukast
Drug: Theophylline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Open-Label Comparative Study of Montelukast Versus Theophylline Added to Inhaled Corticosteroid in Pediatric Patients With Bronchial Asthma

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

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
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: montelukast
montelukast 5 mg QD 4-weeks.
Other Name: MK0476
Active Comparator: 2 Drug: Theophylline
Theophylline 100 to 200 mg BID 4-weeks.


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

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
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Please refer to this study by its identifier: NCT00756418

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00756418     History of Changes
Other Study ID Numbers: 0476-396  MK0476-396  2008_027 
Study First Received: September 19, 2008
Last Updated: April 24, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Enzyme Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Purinergic Agents
Purinergic Antagonists
Purinergic P1 Receptor Antagonists
Respiratory System Agents
Therapeutic Uses
Vasodilator Agents processed this record on February 10, 2016