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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00756418
• Other study ID #: 0476-396
• Secondary ID: MK0476-3962008_0
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2003
• Est. completion date: August 28, 2004

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: August 28, 2004
• Est. primary completion date: August 28, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• montelukast
montelukast 5 mg QD 4-weeks.
• Theophylline
Theophylline 100 to 200 mg BID 4-weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of AM PEF over first 2 Weeks		Over first 2 Weeks