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Montelukast Post-Marketing Comparative Study With Ketotifen (0476-379) | Clinical Trials | Clareo Health

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Montelukast Post-Marketing Comparative Study With Ketotifen (0476-379)

Montelukast, on Pediatric Bronchial Asthma in Multicenter Comparative Double-Blind Clinical Study (Phase IV) With Ketotifen Fumarate

NCT00446056•Organon and Co

View on ClinicalTrials.gov

Summary

The clinical study evaluates the safety of montelukast and compares montelukast to ketotifen, used as a control drug, in terms of improvement in morning peak expiratory flow (am pef) over first 2 weeks in patients with pediatric bronchial asthma aged 6 to \< 15. The effect of body weight on the efficacy and safety of montelukast will also be evaluated in this study.

Eligibility

Age

6 - 14 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Intermittent asthma, mild persistent asthma, moderate persistent asthma, or severe persistent asthma patients with 2 or more mild or moderate attacks at baseline

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

Key Dates

Start Date

September 25, 2003

Primary Completion Date

June 16, 2004

Completion Date

June 16, 2004

Last Updated

August 15, 2024

Enrollment

188

ACTUAL participants

Conditions

Asthma

Interventions

MK0476, montelukast sodium / Duration of Treatment: 4 Weeks

DRUG

Comparator: ketotifen / Duration of Treatment: 4 Weeks

DRUG

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NCT07486401

Asthma ExacerbationsBiomarkers / Blood+1 more

View study

RECRUITING

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

NCT02327897

Asthma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Montelukast Post-Marketing Comparative Study With Ketotifen (0476-379)

Inclusion Criteria

Exclusion Criteria

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

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