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

August 12, 2024 updated by: Organon and Co

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

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

Study Overview

Status

Completed

Conditions

Asthma, Bronchial

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

994

Phase

Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 14 years (Child)

Accepts Healthy Volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement of asthma with MK0476 and Fluticasone as measured by number of asthma rescue-free days Time Frame: Duration of Trial	Duration of Trial

Secondary Outcome Measures

Outcome Measure	Time Frame
Improved effect of MK0476 and fluticasone on FEV1 values Time Frame: Duration of Trial	Duration of Trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Investigators

Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Garcia Garcia ML, Wahn U, Gilles L, Swern A, Tozzi CA, Polos P. Montelukast, compared with fluticasone, for control of asthma among 6- to 14-year-old patients with mild asthma: the MOSAIC study. Pediatrics. 2005 Aug;116(2):360-9. doi: 10.1542/peds.2004-1172. Erratum In: Pediatrics. 2005 Oct;116(4):1058.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Primary Completion (Actual)

June 1, 2002

Study Completion (Actual)

June 1, 2002

Study Registration Dates

First Submitted

June 20, 2007

First Submitted That Met QC Criteria