Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00756418
First received: September 19, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  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 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:

MedlinePlus related topics: Asthma Steroids
U.S. FDA Resources

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
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.

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Theophylline
Montelukast
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Vasodilator Agents
Cardiovascular Agents
Leukotriene Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on May 21, 2013