A Study to Evaluate MK0476 and Fluticasone to Control Asthma in Patients With Mild Persistent Asthma (0476-910)

A study to evaluate MK0476 and Fluticasone to control asthma in patients with mild persistent asthma.

Completed

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Key information

Conditions

Asthma, Bronchial Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient is male or female, 6-14 years of age with mild persistent asthma
Patient has a history of the following symptoms: wheezing, chest tightness, cough, etc.
Patient has asthma diagnosed by a doctor

Exclusion criteria

Patient is hospitalized
Patient has had major surgery or participated in another clinical trial in the last 4 weeks
Patient has been on a breathing tube for asthma

Treatment and study plan

MK0476, montelukast sodium / Duration of Treatment: 1 Year

Drug

Comparator : fluticasone propionate / Duration of Treatment: 1 Year

Drug

Primary outcomes

Improvement of asthma with MK0476 and Fluticasone as measured by number of asthma rescue-free days

Time frame: Duration of Trial

Secondary outcomes

Improved effect of MK0476 and fluticasone on FEV1 values

Time frame: Duration of Trial

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Double-Blind, Randomized, Double-Dummy, Multicenter Study to Evaluate and Compare Oral Montelukast and Inhaled Fluticasone in the Control of Asthma for 6- to 14-Year-Olds With Mild Persistent Asthma

Important dates

Study start: 2001
Primary completion: 2002
Study completion: 2002
First posted: Jun 21, 2007
Registry last updated: Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed