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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: montelukast (Drug); Theophylline (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Improvement of AM PEF over first 2 Weeks


Minimum age: 6 Years. Maximum age: 14 Years. Gender(s): Both.


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


Locations and Contacts

Additional Information

Starting date: June 2003
Last updated: April 24, 2015

Page last updated: August 23, 2015

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