NCT00489346

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
994

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2001

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2002

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2007

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

8 months

First QC Date

June 20, 2007

Last Update Submit

August 12, 2024

Conditions

Asthma, Bronchial

Outcome Measures

Primary Outcomes (1)

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

    Duration of Trial

Secondary Outcomes (1)

  • Improved effect of MK0476 and fluticasone on FEV1 values

    Duration of Trial

Interventions

MK0476, montelukast sodium / Duration of Treatment: 1 YearDRUG
Comparator : fluticasone propionate / Duration of Treatment: 1 YearDRUG

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 16061590BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

montelukastDuration of Therapy

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2007

First Posted

June 21, 2007

Study Start

October 1, 2001

Primary Completion

June 1, 2002

Study Completion

June 1, 2002

Last Updated

August 15, 2024

Record last verified: 2022-02