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

NCT ID: NCT00756418

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-01
• Study Completion Date: 2004-08-28

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

montelukast

Intervention Type: DRUG

montelukast 5 mg QD 4-weeks.

2

Group Type: ACTIVE_COMPARATOR

Theophylline

Intervention Type: DRUG

Theophylline 100 to 200 mg BID 4-weeks.

Interventions

montelukast

montelukast 5 mg QD 4-weeks.

Intervention Type: DRUG

Theophylline

Theophylline 100 to 200 mg BID 4-weeks.

Intervention Type: DRUG

Other Intervention Names

MK0476

Eligibility 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: RESULT

PMID: 17075269 (View on PubMed)

Other Identifiers

MK0476-396

Identifier Type: -

Identifier Source: secondary_id

2008_027

Identifier Type: -

Identifier Source: secondary_id

0476-396

Identifier Type: -

Identifier Source: org_study_id