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

Sponsor
Organon and Co (Industry)
Overall Status
Completed
CT.gov ID
NCT00756418
Collaborator
(none)
84
Enrollment
2
Arms
14.9
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Actual Study Start Date :
Jun 1, 2003
Actual Primary Completion Date :
Aug 28, 2004
Actual Study Completion Date :
Aug 28, 2004

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: montelukast
montelukast 5 mg QD 4-weeks.
Other Names:
  • MK0476

    		•
    Active Comparator: 2

    Drug: Theophylline
    Theophylline 100 to 200 mg BID 4-weeks.

    Outcome Measures

    Primary Outcome Measures

    1. Improvement of AM PEF over first 2 Weeks [Over first 2 Weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 14 Years
    Sexes Eligible for Study:
    All
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Organon and Co

    Investigators

    • Study Director: Medical Monitor, Merck Sharp & Dohme LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Organon and Co
    ClinicalTrials.gov Identifier:
    NCT00756418
    Other Study ID Numbers:
    • 0476-396
    • MK0476-396
    • 2008_027
    First Posted:
    Sep 22, 2008
    Last Update Posted:
    Feb 18, 2022
    Last Verified:
    Feb 1, 2022
    Additional relevant MeSH terms:
    Asthma
    Theophylline
    Montelukast

    Study Results

    No Results Posted as of Feb 18, 2022