NCT00756418

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for phase_4 asthma

Timeline
Completed

Started Jun 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2004

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2008

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

1.2 years

First QC Date

September 19, 2008

Last Update Submit

August 12, 2024

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Improvement of AM PEF over first 2 Weeks

    Over first 2 Weeks

Study Arms (2)

1

EXPERIMENTAL
Drug: montelukast

2

ACTIVE COMPARATOR
Drug: Theophylline

Interventions

montelukastDRUG

montelukast 5 mg QD 4-weeks.

Also known as: MK0476
1
TheophyllineDRUG

Theophylline 100 to 200 mg BID 4-weeks.

2

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kondo N, Katsunuma T, Odajima Y, Morikawa A. A randomized open-label comparative study of montelukast versus theophylline added to inhaled corticosteroid in asthmatic children. Allergol Int. 2006 Sep;55(3):287-93. doi: 10.2332/allergolint.55.287.

    PMID: 17075269RESULT

MeSH Terms

Conditions

Asthma

Interventions

montelukastTheophylline

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2008

First Posted

September 22, 2008

Study Start

June 1, 2003

Primary Completion

August 28, 2004

Study Completion

August 28, 2004

Last Updated

August 15, 2024

Record last verified: 2022-02