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Clinical Trials/NCT00756418
NCT00756418CompletedPhase 4

A Randomized Open-Label Comparative Study of Montelukast Versus Theophylline Added to Inhaled Corticosteroid in Pediatric Patients With Bronchial Asthma

Organon and Co0 sites84 target enrollmentStarted: June 1, 2003Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
84
Primary Endpoint
Improvement of AM PEF over first 2 Weeks
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
6 Years to 14 Years (Child)
Sex
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

Arms & Interventions

1

Experimental

Intervention: montelukast (Drug)

2

Active Comparator

Intervention: Theophylline (Drug)

Outcomes

Primary Outcomes

Improvement of AM PEF over first 2 Weeks

Time Frame: Over first 2 Weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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